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Bone–Patellar Tendon–Bone Versus Soft-Tissue Allograft for Anterior Cruciate Ligament Reconstruction: A Systematic Review
Systematic Review
BoneePatellar TendoneBone Versus Soft-Tissue Allograft for Anterior Cruciate Ligament Reconstruction: A Systematic Review Christopher D. Joyce, B.S., Kyle L. Randall, M.D., Michael W. Mariscalco, M.D., Robert A. Magnussen, M.D., M.P.H., and David C. Flanigan, M.D.
Purpose: To describe the outcomes of boneepatellar tendonebone (BPTB) and soft-tissue allografts in anterior cruciate ligament (ACL) reconstruction with respect to graft failure risk, physical examination findings, instrumented laxity, and patient-reported outcomes. Methods: A search of the PubMed, Scopus, CINAHL (Cumulative Index to Nursing and Allied Health Literature) Complete, Cochrane Collaboration, and SPORTDiscus databases was performed. Englishlanguage studies with outcome data on primary ACL reconstruction with nonirradiated BPTB and soft-tissue allografts were identified. Outcome data included failure risk, physical examination findings, instrumented laxity measurements, and patient-reported outcome scores. Results: Seventeen studies met the inclusion criteria. Of these studies, 11 reported on BPTB allografts exclusively, 5 reported on soft-tissue allografts exclusively, and 1 compared both types. The comparative study showed no difference in failure risk, Lachman grade, pivot-shift grade, instrumented laxity, or overall International Knee Documentation Committee score between the 2 allograft types. Data from all studies yielded a failure risk of 10.3% (95% confidence interval [CI], 4.5% to 18.1%) in the soft-tissue group and 15.2% (95% CI, 11.3% to 19.6%) in the BPTB group. The risk of a Lachman grade greater than 5 mm was 6.4% (95% CI, 1.7% to 13.7%) in the soft-tissue group and 8.6% (95% CI, 6.3% to 11.2%) in the BPTB group. The risk of a grade 2 or 3 pivot shift was 1.4% (95% CI, 0.3% to 3.3%) in the soft-tissue group and 4.1% (95% CI, 1.9% to 7.2%) in the BPTB group. Conclusions: One comparative study showed no difference in results after ACL reconstruction with nonirradiated BPTB and soft-tissue allografts. Inclusion of case series in the analysis showed qualitatively similar outcomes with the 2 graft types. Level of Evidence: Level IV, systematic review of Level III and IV studies.
N
umerous techniques and graft choices have been described for reconstruction of the anterior cruciate ligament (ACL). Surgeon or patient preference, surgeon experience, and patient age and activity level all play a role in graft choice (autograft v allograft). The use of allografts has increased in recent years because they offer less donor-site morbidity, a decreased operative time, and an unlimited graft source in the setting of multiligament and revision reconstructions.1-4
From The Ohio State University Sports Medicine Center and Cartilage Restoration Program, Columbus, Ohio, U.S.A. The authors report the following potential conflict of interest or source of funding: D.C.F. receives support from Smith&Nephew, Vericel, and DePuy Mitek. Received September 29, 2014; accepted August 4, 2015. Address correspondence to David C. Flanigan, M.D., The Ohio State University Sports Medicine Center and Cartilage Restoration Program, 2050 Kenny Rd, Ste 3100, Columbus, OH 43221, U.S.A. E-mail: david.flanigan@ osumc.edu Ó 2015 by the Arthroscopy Association of North America 0749-8063/14820/$36.00 http://dx.doi.org/10.1016/j.arthro.2015.08.003
However, allografts are associated with a higher expense, a risk of disease transmission, and an increased risk of graft rupture in the younger, more active population.3,5-7 There have been numerous systematic reviews comparing the results of autograft hamstring versus boneepatellar tendonebone (BPTB) grafts.8,9 A recent meta-analysis by Mohtadi et al.8 is representative of the typical findings and noted that there was insufficient evidence to recommend one graft choice over the other. Although data from this analysis suggested that patellar tendon autografts produce a more statically stable knee, they were associated with more anterior knee problems. There have also been many studies comparing ACL autograft with allograft.10-14 Prodromos et al.14 showed that the overall stability rate was 72% for all autografts compared with 59% for all allografts (P < .001), which did not account for the effect of irradiation on the allograft tissue. Mariscalco et al.13 compared exclusively nonirradiated allograft tissue with autograft in a
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systematic review and concluded that there was no significant difference between the 2 graft sources in outcomes. The aim of this article is to describe the results of BPTB allografts and soft-tissue allografts for ACL reconstruction. We hypothesize that BPTB and softtissue allografts show no difference in (1) graft failure risk, (2) laxity on postoperative physical examination, (3) instrumented laxity, or (4) patient-reported outcome scores after ACL reconstruction.
Methods Literature Search and Study Selection A review of the literature was performed by 2 authors (C.J. and M.M.) using the PubMed, Scopus, CINAHL (Cumulative Index to Nursing and Allied Health Literature) Complete, Cochrane Collaboration, and SPORTDiscus databases through April 10, 2014. The search terms used were “anterior cruciate ligament,” “allograft,” and [“patellar” OR “soft tissue” OR “hamstring” OR “semitendinosus” OR “tibialis” OR “peroneus” OR “iliotibial” OR “fascia lata” OR “Achilles”]. Completion of the search in each database resulted in a list of 1,579 titles. After removal of all duplicate studies (407), 1,172 titles remained. Articles were excluded according to our inclusion and exclusion criteria as outlined in Table 1, yielding 22 potential articles for inclusion in the review. Seven articles did not mention whether the grafts were irradiated or nonirradiated, and an attempt was made to contact the corresponding author for each article. Five authors did not reply, and these studies were excluded. Seventeen studies remained and were included in this review. The literature search is summarized in Figure 1. Table 1. Inclusion and Exclusion Criteria Inclusion criteria Published prospective series describing outcomes of ACL reconstruction using allograft Minimum follow-up of 2 yr Reconstruction with patellar tendon or soft-tissue allograft Use of nonirradiated graft Exclusion criteria Laboratory or animal studies Follow-up <2 yr Use of graft tissue other than patellar tendon or soft-tissue allograft Use of irradiated graft Unclear graft type or irradiation Use of fascia lata graft Use of Achilles allograft Animal studies Reviews without original data Nonepeer-reviewed studies ACL, anterior cruciate ligament.
Fig 1. Search strategy and results. (CINAHL, Cumulative Index to Nursing and Allied Health Literature.)
Data Extraction Two authors independently extracted data from the 17 studies included in this systematic review. Study descriptive data included country of origin, procedure date range, level of evidence, number of surgeons, allograft type, surgical approach, and femoral and tibial fixation method. Patient demographic data included age, sex, length of follow-up, and follow-up percentage. Outcome data included Lachman grade, pivot-shift grade, overall International Knee Documentation Committee (IKDC) score, Lysholm score, Tegner score, and rerupture risk. Quality Appraisal Two authors independently determined the methodologic quality of each study separately using the Delphi list quality score15 and the modified Coleman methodology score.14 The Delphi list uses 9 questions to score the quality assessment: Was a method of randomization used? Was the treatment allocation concealed? Were the groups similar at baseline? Was eligibility criteria specified? Was the outcome assessor blinded? Was the care provider blinded? Was the patient blinded? Were point estimates and measures of variability used? Was there an intention-to-treat analysis? In this assessment, each study was given 1 point for yes, a 1-point deduction for no, and 0 points for “don’t know.”15 The modified Coleman score is determined by study size, mean follow-up, percentage of patients with follow-up, number of interventions per group, study type, diagnostic certainty of ACL tear, description of ACL reconstruction procedure, description of postoperative rehabilitation, specifications of
3
ALLOGRAFT COMPARISON Table 2. Study Description Author BPTB allograft Bach et al.16 Barrett et al.17 Barrett et al.18 Kleipool et al.21 Lee et al.32 Melberg and Indelicato19 Nin et al.20 Noyes and Barber-Westin22 Peterson et al.23 Siebold et al.24 Sun et al.26 Sun et al.25 Soft-tissue allograft Almqvist et al.31 Lawhorn et al.27 Lee et al.32 Snow et al.28 Sun et al.29 Sun et al.30
Journal
Year
Country
Procedure Date Range
Level of Evidence
AJSM AJSM Arthroscopy KSSTA Arthroscopy SMAR KSSTA JBJS Arthroscopy AOTS KSSTA Arthroscopy
2005 2005 2010 1998 2010 1993 1996 1996 2001 2003 2009 2009
US US US Netherlands Republic of Korea US Spain US US Germany China China
1986-2000 1994-2000 1993-2005 1989-1991 2000-2002 1985-1992 1988-1996 1986-1987 1991-1992 1993-1998 2004-2006 2000-2004
IV IV IV IV III IV IV IV IV IV IV IV
KSSTA Arthroscopy Arthroscopy KSSTA AJSM KSSTA
2009 2012 2010 2010 2011 2012
Belgium US Republic of Korea England China China
1995-1997 2002-2006 2002-2005 NR 2000-2004 2005-2008
IV IV III IV IV IV
AJSM, American Journal of Sports Medicine; AOTS, Archives of Orthopaedic and Trauma Surgery; BPTB, boneepatellar tendonebone; JBJS, Journal of Bone & Joint Surgery; KSSTA, Knee Surgery, Sports Traumatology, Arthroscopy; NR, not reported; SMAR, Sports Medicine and Arthroscopy Review.
outcome criteria, procedures for assessing outcomes, and description of patient selection process.14 The maximum possible modified Coleman score is 100 points, with 85 to 100 points being considered excellent; 70 to 84 points, good; 55 to 69 points, fair; and 54 points or less, poor. Statistical Methods Data extracted and compiled from the BPTB allograft studies were compared with data extracted and compiled from the soft-tissue allograft studies. Data for each graft type were combined using a random-effects model by the method of DerSimonian-Laird to calculate an overall pooled estimate of failure risk, Lachman grade greater than 5 mm, and grade 2 or 3 pivot shift for each graft type.
Results Study Characteristics Seventeen studies meeting the inclusion criteria were reviewed: 11 reported on BPTB allografts exclusively,16-26 5 reported on soft-tissue allografts exclusively (2 hamstring, 2 tibialis anterior, and 1 tibialis anterior and posterior),27-31 and 1 compared both allograft types.32 The level of evidence was determined as related to our research question. One study included Level III evidence,32 and the remaining 16 studies included Level IV evidence16-31 (Table 2). All grafts used in the BPTB group were nonirradiated, fresh-frozen BPTB allografts. In the soft-tissue group, all ACL reconstructions were performed with nonirradiated, fresh-frozen allografts. The surgical technique for each
article, including number of surgeons, approach, and femoral and tibial fixation method, is reported in Table 3. Demographic Characteristics The mean age of the patients who underwent BPTB allograft placement was 32.4 years (range, 13 to 69 years), and the mean age for soft-tissue allograft patients was 29.2 years (range, 15 to 60 years). The mean length of follow-up was 46.9 months (range, 9 to 194 months) in the BPTB group and 57.6 months (range, 24 to 120 months) in the soft-tissue group. The BPTB group contained 61.8% male and 38.2% female patients (we excluded 1 study that did not report sex22), and the soft-tissue group contained 76.6% male and 23.4% female patients. The soft-tissue group contained a higher proportion of male patients, and the overall follow-up percent was higher in the soft-tissue group, at 84.5%, compared with the BPTB group, at 77.9% (Table 4). Qualitative Appraisal Methodologic quality scores for each article were compiled using the Delphi list and modified Coleman scores (Table 4). The average modified Coleman score for all 17 studies was 66.6 points. According to the stratification, there were 3 studies of excellent quality, 3 of good quality, 8 of fair quality, and 3 of poor quality. Comparative Study The 1 identified study that directly compared outcomes between BPTB and soft-tissue allografts showed no difference in failure risk, Lachman grade, pivot-shift
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Table 3. Surgical Details Author BPTB allograft Bach et al.16 (2005)
No. of Surgeons
Allograft Type
Approach
2
BPTB
Barrett et al.17 (2005)
1
BPTB
Endoscopic (56), dual incision (3) Endoscopic
Barrett et al.18 (2010) Kleipool et al.21 (1998) Lee et al.32 (2010) Melberg and Indelicato19 (1993) Nin et al.20 (1996)
1 1 1 1
BPTB BPTB BPTB BPTB
Endoscopic Endoscopic Endoscopic Endoscopic
1
BPTB
1
BPTB
Endoscopic (40), dual incision (20) Mini-arthrotomy (18), endoscopic (10) Endoscopic Endoscopic Endoscopic Endoscopic
Noyes and Barber-Westin22 (1996)
Femoral Fixation Interference screw
Interference screw
Interference screw (33), button (2), button-screw combination (3) NR Interference screw Interference screw Interference screw
Interference screw/post (36), button (2)
NR Interference screw Interference screw Interference screw
Press fit
Screw and washer
NR
NR
Peterson et al.23 (2001) Siebold et al.24 (2003) Sun et al.26 (2009, KSSTA) Sun et al.25 (2009, Arthroscopy) Soft-tissue allograft Almqvist et al.31 (2009)
1 NR 1 1
BPTB BPTB BPTB BPTB
NR
Tibialis anterior, posterior
Endoscopic
Lawhorn et al.27 (2012) Lee et al.32 (2010)
5 1
Tibialis anterior Tibialis anterior
Endoscopic Endoscopic
NR
Tibialis anterior
NR
Doubled hamstring Doubled hamstring
Endoscopic
EndoButton (Smith & Nephew Endoscopy, Andover, MA) EndoButton
Endoscopic
EndoButton
Snow et al.28 (2010)
Sun et al.29 (2011)
1
Sun et al.30 (2012)
1
Tibial Fixation
Interference Interference Interference Interference
screw screw screw screw
Mitek anchors (DePuy Synthes, Warsaw, IN) Cross pin Cross pin
Interference Interference Interference Interference
screw screw screw screw
Interference screw and staple Screw and spiked washer Interference screw and staple Interference screw and staple Interference screw and staple Interference screw
BPTB, boneepatellar tendonebone; KSSTA, Knee Surgery, Sports Traumatology, Arthroscopy; NR, not reported.
grade, instrumented laxity, or overall IKDC score between the 2 allograft types.32 Failure Risk Across All Studies Clinical failure risk was determined using an algorithm described by Crawford et al.33 This standardized failure risk is defined by the following: grade 2þ or worse Lachman, grade 2þ or worse pivot shift, overall IKDC grade C or D, or instrumented laxity with a sideto-side difference greater than 5 mm. In addition, patients with ruptured grafts were not included in the data from 3 studies,16,21,22 and thus the patients with ruptured grafts were added to the clinical failure risk to produce a redefined cumulative failure risk. Six studies did not report the graft rupture risk.17,19,25,26,29,30 The redefined cumulative failure risk in patients with softtissue allografts is reported in Table 5. The pooled failure risk was 10.3% (95% confidence interval [CI],
4.5% to 18.1%) in the soft-tissue allograft group (Fig 2) and 15.2% (95% CI, 11.3% to 19.6%) in the BPTB allograft group (Fig 3). Laxity on Physical Examination Across All Studies Laxity on physical examination was determined with Lachman and pivot-shift testing at follow-up. Lachman testing was reported in 9 BPTB studies and 3 soft-tissue studies (Table 6). The pooled risk of a Lachman grade greater than 5 mm was 6.4% (95% CI, 1.7% to 13.7%) in the soft-tissue allograft group and 8.6% (95% CI, 6.3% to 11.2%) in the BPTB allograft group. Pivot-shift testing was reported in 9 BPTB studies and 4 soft-tissue studies (Table 7). The pooled risk of a grade 2 or 3 pivot shift was 1.4% (95% CI, 0.3% to 3.3%) in the soft-tissue allograft group and 4.1% (95% CI, 1.9% to 7.2%) in the BPTB allograft group.
5
ALLOGRAFT COMPARISON Table 4. Study Demographic Characteristics and Follow-Up
Author BPTB allograft Bach et al.16 (2005) Barrett et al.17 (2005) Barrett et al.18 (2010) Kleipool et al.21 (1998) Melberg and Indelicato19 (1993) Lee et al.32 (2010) Nin et al.20 (1996) Noyes and Barber-Westin22 (1996) Peterson et al.23 (2001) Siebold et al.24 (2003) Sun et al.26 (2009, KSSTA) Sun et al.25 (2009, Arthroscopy) Soft-tissue allograft Almqvist et al.31 (2009) Lawhorn et al.27 (2012) Lee et al.32 (2010) Snow et al.28 (2010) Sun et al.29 (2011) Sun et al.30 (2012)
No. of Patients
Mean Age (Range), yr
Mean Length of Follow-Up (Range), mo
Sex
3 5 7 6 5
55 55 53 69 53
39 (24-96) 47 (24-78) 84 (60-108)
NR 59 100
3 5 3
56 56 68
63 90 100 93
6 5 1 2
56 74 86 94
3 3 3 3 3 1
72 69 56 48 94 84
60 60 28
27.9 (13-60) 23 (16-32) 23 (14-51)
51 M and 9 F 34 M and 26 F NR
30 183 34 80
28 39.8 31.8 33
(15-55) (20-69) (19-64) (19-65)
19 M and 11 F 120 M and 63 F 22 M and 12 F 63 M and 17 F
62.5 39 27.3 67
50 48 153 64 95 38
25 33.3 28.6 27 31 31.7
(17-50) (16-53) (15-60) (16-55) (18-59) (21-56)
36 M and 14 F 38 M and 10 F 127 M and 26 F 33 M and 31 F 78 M and 17 F 31 M and 7 F
NR (120-144)y 24 34 (24-52) 44.5 (24-55) 95 (72-120) 42.1 (31-55)
M M M M M
and and and and and
38 18 48 19 26
F F F F F
Modified Coleman Methodology Score
66 100 70 92 43
41 47 28.1 28 25
21 20 30 17 67
Delphi Score
(26-170) (24-74) (9-194) (30-64) (24-51)
59* 38 78 36 93
(18-61) (40-58) (13-39) (14-43) (14-49)
% Follow-Up
51 36.4 62.7 46 30
(55-73) (24-74) (14-44) (50-96)
83.3 65.7 NR 87.7 91 97.4
BPTB, boneepatellar tendonebone; F, female; KSSTA, Knee Surgery, Sports Traumatology, Arthroscopy; M, male; NR, not reported. *One patient underwent bilateral ACL repairs (59 patients, 60 knees). y For average calculation, a follow-up time of 120 months was used.
Instrumented Laxity Across All Studies Laxity was measured with either a KT-1000 or KT2000 arthrometer (MEDmetric, San Diego, CA) in 10 BPTB studies and 5 soft-tissue studies (Table 8). The pooled risk of instrumented anteroposterior laxity greater than 5 mm was 4.4% (95% CI, 0.6% to 11.6%) in the soft-tissue allograft group and 4.9% (95% CI, 2.8% to 7.4%) in the BPTB allograft group. Overall IKDC Score Across All Studies Eight BPTB studies and 4 soft-tissue studies used the objective IKDC scoring system to describe the results of the ACL reconstruction as normal (A), nearly normal (B), abnormal (C), and severely abnormal (D) (Table 9). The pooled risk of having an overall IKDC score of C or D was 6.5% (95% CI, 2.4% to 12.4%) in the soft-tissue allograft group and 12.2% (95% CI, 9.3% to 15.3%) in the BPTB allograft group. Patient-Reported Outcome Scores Across All Studies Mean Lysholm scores at follow-up ranged from 88 to 90 in the soft-tissue allograft group and from 82 to 94 in the BPTB allograft group. Mean Tegner scores at followup ranged from 6.5 to 7.6 in the soft-tissue allograft group and from 4.1 to 7.6 in the BPTB allograft group (Table 10).
Discussion Although both BPTB and soft-tissue allografts are used in clinical practice, this systematic review identified only 1 study in the literature that directly compared these grafts. The study showed no significant differences in any outcome variable between the 2 grafts.32 Expansion of this systematic review to include the Level IV evidence available on this topic showed qualitatively similar findings to the 1 comparative study on this topic. By pooling data from all available studies of the outcomes of ACL reconstruction with nonirradiated allograft, we constructed 95% CIs for the risk of graft failure, increased knee anteroposterior and rotational laxity, and fair/poor overall IKDC scores. Although direct statistical comparison of these studies is precluded by potential differences in patient populations, the overlap between the calculated CIs lends support to the findings of the comparative study that the choice of nonirradiated allograft (soft tissue v BPTB) is likely not a major determinant of outcomes. There are additional studies in the literature comparing allograft types that were not included in our review because of the inclusion and exclusion criteria. A recent study by O’Brien et al.34 compared nonirradiated BPTB allografts with doubled tibialis anterior allografts in patients younger than 30 years. The study was a retrospective matched-pair comparison with 20
6
Table 5. Failure Risk Stated Rerupture Rate
Abnormal Lachman Grade
Abnormal Pivot-Shift Grade
Abnormal Instrumented Laxity
IKDC Overall Grade C or D
61 38 78 37 93
1/61 NR 12/78 1/37 NR
4/60 1/38 NR 5/36 10/93
1/60 1/38 NR 3/36 7/93
0/60 3/38 NR 2/36 4/93
0/60 5/38 NR 6/36 7/93
4/60 5/38 19/78 6/36 7/60
60 60 30
5/60 0/60 2/30
2/60 6/60 NR
2/60 6/60 NR
NR NR 1/28
7/60 9/60 6/28
10/93 (10.8%) 9/60 (15%) 6/28 (21.4%)
10/93 (10.8%) (95% CI, 5.3%-18.9%) 9/60 (15%) (95% CI, 7.1%-26.6%) 8/30 (26.7%) (95% CI, 12.3%-45.9%)
30 183 34 80
1/30 19/183 NR NR
3/30 NR 3/34 6/80
1/30 NR 0/34 0/80
0/30 8/164 3/34 6/80
NR 26/164 3/34 5/80
3/30 (10%) 45/183 (24.6%) 3/34 (8.8%) 6/80 (7.5%)
3/30 (10%) (95% CI, 2.1%-26.5%) 45/183 (24.6%) (95% CI, 18.5%-31.5%) 3/34 (8.8%) (95% CI, 1.9%-23.7%) 6/80 (7.5%) (95% CI, 2.8%-15.6%)
55 48 153 64 95 38
5/55 0/48 5/153 5/64 NR NR
NR NR 3/153 NR 8/95 4/38
NR 0/48 4/153 1/25 0/95 0/38
NR 0/48 NR 0/25 8/95 4/38
11/50 0/48 11/153 3/59 9/95 4/38
11/50 (22%) 0/48 (0%) 11/153 (7.2%) 8/64 (12.5%) 9/95 (9.5%) 4/38 (10.5%)
16/55 (29.1%) (95% CI, 17.6%-42.9%) 0/48 (0%) (95% CI, 0.0%-7.4%) 11/153 (7.2%) (95% CI, 3.6%-12.5%) 8/64 (12.5%) (95% CI, 5.6%-23.2%) 9/95 (9.5%) (95% CI, 4.4%-17.2%) 4/38 (10.5%) (95% CI, 2.9%-24.8%)
Clinical Failure* (6.7%) (13.2%) (24.4%) (16.7%) (11.7%)
Redefined Cumulative Failure Risk 5/61 5/38 19/78 7/37 7/60
(8.2%) (95% CI, 2.7%-18.1%) (13.2%) (95% CI, 4.4%-28.1%) (24.4%) (95% CI, 15.3%-35.4%) (18.9%) (95% CI, 8.0%-35.2%) (11.7%) (95% CI, 4.8%-22.6%)
BPTB, boneepatellar tendonebone; CI, confidence interval; IKDC, International Knee Documentation Committee; KSSTA, Knee Surgery, Sports Traumatology, Arthroscopy; NR, not reported. *Clinical failure risk as defined by Crawford et al.33
C. D. JOYCE ET AL.
Author BPTB allograft Bach et al.16 (2005) Barrett et al.17 (2005) Barrett et al.18 (2010) Kleipool et al.21 (1998) Melberg and Indelicato19 (1993) Lee et al.32 (2010) Nin et al.20 (1996) Noyes and Barber-Westin22 (1996) Peterson et al.23 (2001) Siebold et al.24 (2003) Sun et al.26 (2009, KSSTA) Sun et al.25 (2009, Arthroscopy) Soft-tissue allograft Almqvist et al.31 (2009) Lawhorn et al.27 (2012) Lee et al.32 (2010) Snow et al.28 (2010) Sun et al.29 (2011) Sun et al.30 (2012)
No. of Patients
7
ALLOGRAFT COMPARISON Table 6. Lachman Grade at Follow-Up
Fig 2. Forest plot showing risk of graft failure after anterior cruciate ligament reconstruction with soft-tissue allograft. The overall pooled risk of graft failure is 10.3% (95% confidence interval, 4.5% to 18.1%).
patients in each group; however, follow-up was less than 2 years. The authors showed no significant difference between the 2 grafts with respect to graft rupture risk or patient-reported outcomes. Noyes et al.35 studied BPTB allografts and fascia lata allografts in a prospective study that concluded that BPTB allografts had significantly lower anteroposterior displacement with KT-1000 testing than fascia lata allografts. There was no significant difference in the final rating between the 2 groups. No direct comparison was made between the 2 groups regarding physical examination findings or graft failure risk. The authors concluded that BPTB allografts were more effective at restoring anteroposterior translation than fascia lata grafts because of firmer fixation of the osseous portion of the graft. The BPTB patients from their study were included in a later study by Noyes and Barber-Westin22 with longer follow-up that is included in this review. The patients with fascia lata grafts were not included in this review.
Author BPTB allograft Bach et al.16 (2005) Barrett et al.17 (2005) Kleipool et al.21 (1998) Melberg and Indelicato19 (1993) Lee et al.32 (2010) Nin et al.20 (1996) Peterson et al.23 (2001) Sun et al.26 (2009, KSSTA) Sun et al.25 (2009, Arthroscopy) Soft-tissue allograft Lee et al.32 (2010) Sun et al.29 (2011) Sun et al.30 (2012)
Grade
No. of Patients
0
1
2
3
60 38 36 93 60 60 30 34 80
39 31 21 47 53 43 24 28 65
17 6 10 36 5 11 3 3 9
4 1 5 6 2 6 3 3 6
0 0 0 4 0 0 0 0 0
153 95 38
139 78 30
11 9 4
3 8 4
0 0 0
BPTB, boneepatellar tendonebone; KSSTA, Knee Surgery, Sports Traumatology, Arthroscopy.
One strength of our study is that it is the only systematic review comparing nonirradiated soft-tissue allografts with BPTB allografts in the literature. The findings of this study, including the estimated risks of failure and poor outcomes, may not apply when irradiated tissue is used for ACL reconstruction. A second strength is the standardized and comprehensive manner in which this review was conducted. Limitations The study does have significant limitations. One limitation is the relatively small number of studies reporting on soft-tissue allografts (6 studies) compared with BPTB allografts (12 studies), leading to the inclusion of more patients with BPTB allografts in this review. Furthermore, concomitant intra-articular injuries varied greatly among the studies, potentially altering the outcomes of Table 7. Pivot-Shift Grade at Follow-Up
Fig 3. Forest plot showing risk of graft failure after anterior cruciate ligament reconstruction with boneepatellar tendonebone allograft. The overall pooled risk of graft failure is 15.2% (95% confidence interval, 11.3% to 19.6%). (KSSTA, Knee Surgery, Sports Traumatology, Arthroscopy.)
Author BPTB allograft Bach et al.16 (2005) Barrett et al.17 (2005) Kleipool et al.21 (1998) Lee et al.32 (2010) Melberg and Indelicato19 (1993) Nin et al.20 (1996) Peterson et al.23 (2001) Sun et al.26 (2009, KSSTA) Sun et al.25 (2009, Arthroscopy) Soft-tissue allograft Lawhorn et al.27 (2012) Lee et al.32 (2010) Snow et al.28 (2010) Sun et al.29 (2011) Sun et al.30 (2012)
Grade
No. of Patients
0
1
2
3
60 38 36 60 93 60 30 34 80
54 34 28 53 63 43 25 31 74
5 3 5 5 23 11 4 3 6
0 1 3 2 7 6 1 0 0
1 0 0 0 0 0 0 0 0
48 153 25 95 38
44 137 18 87 34
4 12 6 8 4
0 4 1 0 0
0 0 0 0 0
BPTB, boneepatellar tendonebone; KSSTA, Knee Surgery, Sports Traumatology, Arthroscopy.
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C. D. JOYCE ET AL.
Table 8. Instrumented Laxity Measurements
Table 10. Postoperative Patient-Reported Outcome Scores Side-to-Side Difference
Author BPTB allograft Bach et al.16 (2005) Barrett et al.17 (2005) Kleipool et al.21 (1998) Melberg and Indelicato19 (1993) Noyes and Barber-Westin22 (1996) Peterson et al.23 (2001) Siebold et al.24 (2003) Sun et al.26 (2009, KSSTA) Sun et al.25 (2009, Arthroscopy) Soft-tissue allograft Lawhorn et al.27 (2012) Snow et al.28 (2010) Sun et al.29 (2011) Sun et al.30 (2012)
No. of Patients
<3 mm
3-5 mm
>5 mm
60 38 36 93 28 30 164 34 80
57 33 27 80 23 22 107 29 67
3 2 7 9 4 8 49 2 7
0 3 2 4 1 0 8 3 6
48 25 95 38
43 15 78 32
5 10 9 2
0 0 8 4
NOTE. Instrumented laxity was measured with either a KT-1000 or KT-2000 arthrometer. BPTB, boneepatellar tendonebone; KSSTA, Knee Surgery, Sports Traumatology, Arthroscopy.
each study. The use of a random-effects model in the meta-analysis allows modeling of these differences, but the overall estimate of failure risk is dependent to some extent on these associated pathologies. The largest limitation is that only 1 comparative study was identified. The remaining studies are all case series, introducing multiple possible biases into the results if the 2 patient groups were directly compared because of many potential differences in the patient groups that cannot be controlled for. One such difference in the groups is that the soft-tissue allograft group had a significantly larger number of male patients. Previous work suggests that male patients may exhibit decreased laxity compared Table 9. Overall International Knee Documentation Committee Grade at Follow-Up
Author BPTB allograft Barrett et al.17 (2005) Kleipool et al.21 (1998) Melberg and Indelicato19 (1993) Lee et al.32 (2010) Nin et al.20 (1996) Siebold et al.24 (2003) Sun et al.26 (2009, KSSTA) Sun et al.25 (2009, Arthroscopy) Soft-tissue allograft Lawhorn et al.27 (2012) Lee et al.32 (2010) Sun et al.29 (2011) Sun et al.30 (2012)
Grade
No. of Patients
A
B
C
D
38 36 93 60 60 164 34 80
19 17 50 25 30 48 12 30
14 13 36 28 21 90 19 45
5 5 5 6 8 26 2 4
0 1 2 1 1 0 1 1
48 153 95 38
43 65 33 12
5 77 53 22
0 11 8 3
0 0 1 1
BPTB, boneepatellar tendonebone; KSSTA, Knee Surgery, Sports Traumatology, Arthroscopy.
Author BPTB allograft Bach et al.16 (2005) Barrett et al.17 (2005) Barrett et al.18 (2010) Kleipool et al.21 (1998) Peterson et al.23 (2001) Sun et al.26 (2009, KSSTA) Sun et al.25 (2009, Arthroscopy) Soft-tissue allograft Snow et al.28 (2010) Sun et al.29 (2011) Sun et al.30 (2012)
Lysholm Score
Tegner Score
82 17 91 83 94 90 91 8 91 6
6 4.1 5 5 5.4 7.5 7.6
88 90 8 90 7
6.5 7.6 7.3
NOTE. Data are presented as mean or mean SD. BPTB, boneepatellar tendonebone; KSSTA, Knee Surgery, Sports Traumatology, Arthroscopy.
with female patients after ACL reconstruction.36 The identification of only 1 comparative study in the literature on this subject should serve as a call for further comparative studies in this area.
Conclusions One comparative study showed no difference in results after ACL reconstruction with nonirradiated BPTB and soft-tissue allografts. Inclusion of case series in the analysis showed qualitatively similar outcomes with the 2 graft types.
References 1. Shaerf DA, Pastides PS, Sarraf KM, Willis-Owen CA. Anterior cruciate ligament reconstruction best practice: A review of graft choice. World J Orthop 2014;5:23-29. 2. Miller MD, Harner CD. The use of allograft. Techniques and results. Clin Sports Med 1993;12:757-770. 3. Baer GS, Harner CD. Clinical outcomes of allograft versus autograft in anterior cruciate ligament reconstruction. Clin Sports Med 2007;26:661-681. 4. Duquin TR, Wind WM, Fineberg MS, Smolinski RJ, Buyea CM. Current trends in anterior cruciate ligament reconstruction. J Knee Surg 2009;22:7-12. 5. Greis PE, Koch BS, Adams B. Tibialis anterior or posterior allograft anterior cruciate ligament reconstruction versus hamstring autograft reconstruction: An economic analysis in a hospital-based outpatient setting. Arthroscopy 2012;28: 1695-1701. 6. Asselmeier MA, Caspari RB, Bottenfield S. A review of allograft processing and sterilization techniques and their role in transmission of the human immunodeficiency virus. Am J Sports Med 1993;21:170-175. 7. Kaeding CC, Aros B, Pedroza A, et al. Allograft versus autograft anterior cruciate ligament reconstruction: Predictors of failure from a MOON prospective longitudinal cohort. Sports Health 2011;3:73-81. 8. Mohtadi NG, Chan DS, Dainty KN, Whelan DB. Patellar tendon versus hamstring tendon autograft for anterior
ALLOGRAFT COMPARISON
9.
10.
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14.
15.
16.
17.
18.
19. 20.
21.
22.
cruciate ligament rupture in adults. Cochrane Database Syst Rev 2011;7:CD005960. Li S, Chen Y, Lin Z, Cui W, Zhao J, Su W. A systematic review of randomized controlled clinical trials comparing hamstring autografts versus bone-patellar tendon-bone autografts for the reconstruction of the anterior cruciate ligament. Arch Orthop Trauma Surg 2012;132:1287-1297. Foster TE, Wolfe BL, Ryan S, Silvestri L, Kaye EK. Does the graft source really matter in the outcome of patients undergoing anterior cruciate ligament reconstruction? An evaluation of autograft versus allograft reconstruction results: A systematic review. Am J Sports Med 2010;38: 189-199. Carey JL, Dunn WR, Dahm DL, Zeger SL, Spindler KP. A systematic review of anterior cruciate ligament reconstruction with autograft compared with allograft. J Bone Joint Surg Am 2009;91:2242-2250. Krych AJ, Jackson JD, Hoskin TL, Dahm DL. A metaanalysis of patellar tendon autograft versus patellar tendon allograft in anterior cruciate ligament reconstruction. Arthroscopy 2008;24:292-298. Mariscalco MW, Magnussen RA, Mehta D, Hewett TE, Flanigan DC, Kaeding CC. Autograft versus nonirradiated allograft tissue for anterior cruciate ligament reconstruction: A systematic review. Am J Sports Med 2014;42: 492-499. Prodromos C, Joyce B, Shi K. A meta-analysis of stability of autografts compared to allografts after anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthrosc 2007;15:851-856. Verhagen AP, de Vet HC, de Bie RA, et al. The Delphi list: A criteria list for quality assessment of randomized clinical trials for conducting systematic reviews developed by Delphi consensus. J Clin Epidemiol 1998;51:1235-1241. Bach BR Jr, Aadalen KJ, Dennis MG, et al. Primary anterior cruciate ligament reconstruction using freshfrozen, nonirradiated patellar tendon allograft: Minimum 2-year follow-up. Am J Sports Med 2005;33:284-292. Barrett G, Stokes D, White M. Anterior cruciate ligament reconstruction in patients older than 40 years: Allograft versus autograft patellar tendon. Am J Sports Med 2005;33: 1505-1512. Barrett GR, Luber K, Replogle WH, Manley JL. Allograft anterior cruciate ligament reconstruction in the young, active patient: Tegner activity level and failure rate. Arthroscopy 2010;26:1593-1601. Melberg MW, Indelicato PA. Fresh-frozen allograft experience. Sports Med Arthrosc 1993;1:77-88. Nin JR, Leyes M, Schweitzer D. Anterior cruciate ligament reconstruction with fresh-frozen patellar tendon allografts: Sixty cases with 2 years’ minimum follow-up. Knee Surg Sports Traumatol Arthrosc 1996;4:137-142. Kleipool AE, Zijl JA, Willems WJ. Arthroscopic anterior cruciate ligament reconstruction with bone-patellar tendon-bone allograft or autograft. A prospective study with an average follow up of 4 years. Knee Surg Sports Traumatol Arthrosc 1998;6:224-230. Noyes FR, Barber-Westin SD. Reconstruction of the anterior cruciate ligament with human allograft. Comparison of early and later results. J Bone Joint Surg Am 1996;78:524-537.
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23. Peterson RK, Shelton WR, Bomboy AL. Allograft versus autograft patellar tendon anterior cruciate ligament reconstruction: A 5-year follow-up. Arthroscopy 2001;17:9-13. 24. Siebold R, Buelow JU, Bos L, Ellermann A. Primary ACL reconstruction with fresh-frozen patellar versus Achilles tendon allografts. Arch Orthop Trauma Surg 2003;123: 180-185. 25. Sun K, Tian SQ, Zhang JH, Xia CS, Zhang CL, Yu TB. Anterior cruciate ligament reconstruction with bone-patellar tendon-bone autograft versus allograft. Arthroscopy 2009;25: 750-759. 26. Sun K, Tian S, Zhang J, Xia C, Zhang C, Yu T. Anterior cruciate ligament reconstruction with BPTB autograft, irradiated versus non-irradiated allograft: A prospective randomized clinical study. Knee Surg Sports Traumatol Arthrosc 2009;17:464-474. 27. Lawhorn KW, Howell SM, Traina SM, Gottlieb JE, Meade TD, Freedberg HI. The effect of graft tissue on anterior cruciate ligament outcomes: A multicenter, prospective, randomized controlled trial comparing autograft hamstrings with fresh-frozen anterior tibialis allograft. Arthroscopy 2012;28:1079-1086. 28. Snow M, Campbell G, Adlington J, Stanish WD. Two to five year results of primary ACL reconstruction using doubled tibialis anterior allograft. Knee Surg Sports Traumatol Arthrosc 2010;18:1374-1378. 29. Sun K, Zhang J, Wang Y, et al. Arthroscopic reconstruction of the anterior cruciate ligament with hamstring tendon autograft and fresh-frozen allograft: A prospective, randomized controlled study. Am J Sports Med 2011;39: 1430-1438. 30. Sun K, Zhang J, Wang Y, et al. A prospective randomized comparison of irradiated and non-irradiated hamstring tendon allograft for ACL reconstruction. Knee Surg Sports Traumatol Arthrosc 2012;20:187-194. 31. Almqvist KF, Willaert P, De Brabandere S, Criel K, Verdonk R. A long-term study of anterior cruciate ligament allograft reconstruction. Knee Surg Sports Traumatol Arthrosc 2009;17:818-822. 32. Lee JH, Bae DK, Song SJ, Cho SM, Yoon KH. Comparison of clinical results and second-look arthroscopy findings after arthroscopic anterior cruciate ligament reconstruction using 3 different types of grafts. Arthroscopy 2010;26: 41-49. 33. Crawford SN, Waterman BR, Lubowitz JH. Long-term failure of anterior cruciate ligament reconstruction. Arthroscopy 2013;29:1566-1571. 34. O’Brien DF, Kraeutler MJ, Koyonos L, Flato RR, Ciccotti MG, Cohen SB. Allograft anterior cruciate ligament reconstruction in patients younger than 30 years: A matched-pair comparison of bone-patellar tendon-bone and tibialis anterior. Am J Orthop (Belle Mead NJ) 2014;43: 132-136. 35. Noyes FR, Barber SD, Mangine RE. Bone-patellar ligament-bone and fascia lata allografts for reconstruction of the anterior cruciate ligament. J Bone Joint Surg Am 1990;72:1125-1136. 36. Ryan J, Magnussen RA, Cox CL, Hurbanek JG, Flanigan DC, Kaeding CC. ACL reconstruction: Do outcomes differ by sex? A systematic review. J Bone Joint Surg Am 2014;96:507-512.
BoneePatellar TendoneBone Versus Soft-Tissue Allograft for Anterior Cruciate Ligament Reconstruction: A Systematic Review Christopher D. Joyce, B.S., Kyle L. Randall, M.D., Michael W. Mariscalco, M.D., Robert A. Magnussen, M.D., M.P.H., and David C. Flanigan, M.D.
Purpose: To describe the outcomes of boneepatellar tendonebone (BPTB) and soft-tissue allografts in anterior cruciate ligament (ACL) reconstruction with respect to graft failure risk, physical examination findings, instrumented laxity, and patient-reported outcomes. Methods: A search of the PubMed, Scopus, CINAHL (Cumulative Index to Nursing and Allied Health Literature) Complete, Cochrane Collaboration, and SPORTDiscus databases was performed. Englishlanguage studies with outcome data on primary ACL reconstruction with nonirradiated BPTB and soft-tissue allografts were identified. Outcome data included failure risk, physical examination findings, instrumented laxity measurements, and patient-reported outcome scores. Results: Seventeen studies met the inclusion criteria. Of these studies, 11 reported on BPTB allografts exclusively, 5 reported on soft-tissue allografts exclusively, and 1 compared both types. The comparative study showed no difference in failure risk, Lachman grade, pivot-shift grade, instrumented laxity, or overall International Knee Documentation Committee score between the 2 allograft types. Data from all studies yielded a failure risk of 10.3% (95% confidence interval [CI], 4.5% to 18.1%) in the soft-tissue group and 15.2% (95% CI, 11.3% to 19.6%) in the BPTB group. The risk of a Lachman grade greater than 5 mm was 6.4% (95% CI, 1.7% to 13.7%) in the soft-tissue group and 8.6% (95% CI, 6.3% to 11.2%) in the BPTB group. The risk of a grade 2 or 3 pivot shift was 1.4% (95% CI, 0.3% to 3.3%) in the soft-tissue group and 4.1% (95% CI, 1.9% to 7.2%) in the BPTB group. Conclusions: One comparative study showed no difference in results after ACL reconstruction with nonirradiated BPTB and soft-tissue allografts. Inclusion of case series in the analysis showed qualitatively similar outcomes with the 2 graft types. Level of Evidence: Level IV, systematic review of Level III and IV studies.
N
umerous techniques and graft choices have been described for reconstruction of the anterior cruciate ligament (ACL). Surgeon or patient preference, surgeon experience, and patient age and activity level all play a role in graft choice (autograft v allograft). The use of allografts has increased in recent years because they offer less donor-site morbidity, a decreased operative time, and an unlimited graft source in the setting of multiligament and revision reconstructions.1-4
From The Ohio State University Sports Medicine Center and Cartilage Restoration Program, Columbus, Ohio, U.S.A. The authors report the following potential conflict of interest or source of funding: D.C.F. receives support from Smith&Nephew, Vericel, and DePuy Mitek. Received September 29, 2014; accepted August 4, 2015. Address correspondence to David C. Flanigan, M.D., The Ohio State University Sports Medicine Center and Cartilage Restoration Program, 2050 Kenny Rd, Ste 3100, Columbus, OH 43221, U.S.A. E-mail: david.flanigan@ osumc.edu Ó 2015 by the Arthroscopy Association of North America 0749-8063/14820/$36.00 http://dx.doi.org/10.1016/j.arthro.2015.08.003
However, allografts are associated with a higher expense, a risk of disease transmission, and an increased risk of graft rupture in the younger, more active population.3,5-7 There have been numerous systematic reviews comparing the results of autograft hamstring versus boneepatellar tendonebone (BPTB) grafts.8,9 A recent meta-analysis by Mohtadi et al.8 is representative of the typical findings and noted that there was insufficient evidence to recommend one graft choice over the other. Although data from this analysis suggested that patellar tendon autografts produce a more statically stable knee, they were associated with more anterior knee problems. There have also been many studies comparing ACL autograft with allograft.10-14 Prodromos et al.14 showed that the overall stability rate was 72% for all autografts compared with 59% for all allografts (P < .001), which did not account for the effect of irradiation on the allograft tissue. Mariscalco et al.13 compared exclusively nonirradiated allograft tissue with autograft in a
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systematic review and concluded that there was no significant difference between the 2 graft sources in outcomes. The aim of this article is to describe the results of BPTB allografts and soft-tissue allografts for ACL reconstruction. We hypothesize that BPTB and softtissue allografts show no difference in (1) graft failure risk, (2) laxity on postoperative physical examination, (3) instrumented laxity, or (4) patient-reported outcome scores after ACL reconstruction.
Methods Literature Search and Study Selection A review of the literature was performed by 2 authors (C.J. and M.M.) using the PubMed, Scopus, CINAHL (Cumulative Index to Nursing and Allied Health Literature) Complete, Cochrane Collaboration, and SPORTDiscus databases through April 10, 2014. The search terms used were “anterior cruciate ligament,” “allograft,” and [“patellar” OR “soft tissue” OR “hamstring” OR “semitendinosus” OR “tibialis” OR “peroneus” OR “iliotibial” OR “fascia lata” OR “Achilles”]. Completion of the search in each database resulted in a list of 1,579 titles. After removal of all duplicate studies (407), 1,172 titles remained. Articles were excluded according to our inclusion and exclusion criteria as outlined in Table 1, yielding 22 potential articles for inclusion in the review. Seven articles did not mention whether the grafts were irradiated or nonirradiated, and an attempt was made to contact the corresponding author for each article. Five authors did not reply, and these studies were excluded. Seventeen studies remained and were included in this review. The literature search is summarized in Figure 1. Table 1. Inclusion and Exclusion Criteria Inclusion criteria Published prospective series describing outcomes of ACL reconstruction using allograft Minimum follow-up of 2 yr Reconstruction with patellar tendon or soft-tissue allograft Use of nonirradiated graft Exclusion criteria Laboratory or animal studies Follow-up <2 yr Use of graft tissue other than patellar tendon or soft-tissue allograft Use of irradiated graft Unclear graft type or irradiation Use of fascia lata graft Use of Achilles allograft Animal studies Reviews without original data Nonepeer-reviewed studies ACL, anterior cruciate ligament.
Fig 1. Search strategy and results. (CINAHL, Cumulative Index to Nursing and Allied Health Literature.)
Data Extraction Two authors independently extracted data from the 17 studies included in this systematic review. Study descriptive data included country of origin, procedure date range, level of evidence, number of surgeons, allograft type, surgical approach, and femoral and tibial fixation method. Patient demographic data included age, sex, length of follow-up, and follow-up percentage. Outcome data included Lachman grade, pivot-shift grade, overall International Knee Documentation Committee (IKDC) score, Lysholm score, Tegner score, and rerupture risk. Quality Appraisal Two authors independently determined the methodologic quality of each study separately using the Delphi list quality score15 and the modified Coleman methodology score.14 The Delphi list uses 9 questions to score the quality assessment: Was a method of randomization used? Was the treatment allocation concealed? Were the groups similar at baseline? Was eligibility criteria specified? Was the outcome assessor blinded? Was the care provider blinded? Was the patient blinded? Were point estimates and measures of variability used? Was there an intention-to-treat analysis? In this assessment, each study was given 1 point for yes, a 1-point deduction for no, and 0 points for “don’t know.”15 The modified Coleman score is determined by study size, mean follow-up, percentage of patients with follow-up, number of interventions per group, study type, diagnostic certainty of ACL tear, description of ACL reconstruction procedure, description of postoperative rehabilitation, specifications of
3
ALLOGRAFT COMPARISON Table 2. Study Description Author BPTB allograft Bach et al.16 Barrett et al.17 Barrett et al.18 Kleipool et al.21 Lee et al.32 Melberg and Indelicato19 Nin et al.20 Noyes and Barber-Westin22 Peterson et al.23 Siebold et al.24 Sun et al.26 Sun et al.25 Soft-tissue allograft Almqvist et al.31 Lawhorn et al.27 Lee et al.32 Snow et al.28 Sun et al.29 Sun et al.30
Journal
Year
Country
Procedure Date Range
Level of Evidence
AJSM AJSM Arthroscopy KSSTA Arthroscopy SMAR KSSTA JBJS Arthroscopy AOTS KSSTA Arthroscopy
2005 2005 2010 1998 2010 1993 1996 1996 2001 2003 2009 2009
US US US Netherlands Republic of Korea US Spain US US Germany China China
1986-2000 1994-2000 1993-2005 1989-1991 2000-2002 1985-1992 1988-1996 1986-1987 1991-1992 1993-1998 2004-2006 2000-2004
IV IV IV IV III IV IV IV IV IV IV IV
KSSTA Arthroscopy Arthroscopy KSSTA AJSM KSSTA
2009 2012 2010 2010 2011 2012
Belgium US Republic of Korea England China China
1995-1997 2002-2006 2002-2005 NR 2000-2004 2005-2008
IV IV III IV IV IV
AJSM, American Journal of Sports Medicine; AOTS, Archives of Orthopaedic and Trauma Surgery; BPTB, boneepatellar tendonebone; JBJS, Journal of Bone & Joint Surgery; KSSTA, Knee Surgery, Sports Traumatology, Arthroscopy; NR, not reported; SMAR, Sports Medicine and Arthroscopy Review.
outcome criteria, procedures for assessing outcomes, and description of patient selection process.14 The maximum possible modified Coleman score is 100 points, with 85 to 100 points being considered excellent; 70 to 84 points, good; 55 to 69 points, fair; and 54 points or less, poor. Statistical Methods Data extracted and compiled from the BPTB allograft studies were compared with data extracted and compiled from the soft-tissue allograft studies. Data for each graft type were combined using a random-effects model by the method of DerSimonian-Laird to calculate an overall pooled estimate of failure risk, Lachman grade greater than 5 mm, and grade 2 or 3 pivot shift for each graft type.
Results Study Characteristics Seventeen studies meeting the inclusion criteria were reviewed: 11 reported on BPTB allografts exclusively,16-26 5 reported on soft-tissue allografts exclusively (2 hamstring, 2 tibialis anterior, and 1 tibialis anterior and posterior),27-31 and 1 compared both allograft types.32 The level of evidence was determined as related to our research question. One study included Level III evidence,32 and the remaining 16 studies included Level IV evidence16-31 (Table 2). All grafts used in the BPTB group were nonirradiated, fresh-frozen BPTB allografts. In the soft-tissue group, all ACL reconstructions were performed with nonirradiated, fresh-frozen allografts. The surgical technique for each
article, including number of surgeons, approach, and femoral and tibial fixation method, is reported in Table 3. Demographic Characteristics The mean age of the patients who underwent BPTB allograft placement was 32.4 years (range, 13 to 69 years), and the mean age for soft-tissue allograft patients was 29.2 years (range, 15 to 60 years). The mean length of follow-up was 46.9 months (range, 9 to 194 months) in the BPTB group and 57.6 months (range, 24 to 120 months) in the soft-tissue group. The BPTB group contained 61.8% male and 38.2% female patients (we excluded 1 study that did not report sex22), and the soft-tissue group contained 76.6% male and 23.4% female patients. The soft-tissue group contained a higher proportion of male patients, and the overall follow-up percent was higher in the soft-tissue group, at 84.5%, compared with the BPTB group, at 77.9% (Table 4). Qualitative Appraisal Methodologic quality scores for each article were compiled using the Delphi list and modified Coleman scores (Table 4). The average modified Coleman score for all 17 studies was 66.6 points. According to the stratification, there were 3 studies of excellent quality, 3 of good quality, 8 of fair quality, and 3 of poor quality. Comparative Study The 1 identified study that directly compared outcomes between BPTB and soft-tissue allografts showed no difference in failure risk, Lachman grade, pivot-shift
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Table 3. Surgical Details Author BPTB allograft Bach et al.16 (2005)
No. of Surgeons
Allograft Type
Approach
2
BPTB
Barrett et al.17 (2005)
1
BPTB
Endoscopic (56), dual incision (3) Endoscopic
Barrett et al.18 (2010) Kleipool et al.21 (1998) Lee et al.32 (2010) Melberg and Indelicato19 (1993) Nin et al.20 (1996)
1 1 1 1
BPTB BPTB BPTB BPTB
Endoscopic Endoscopic Endoscopic Endoscopic
1
BPTB
1
BPTB
Endoscopic (40), dual incision (20) Mini-arthrotomy (18), endoscopic (10) Endoscopic Endoscopic Endoscopic Endoscopic
Noyes and Barber-Westin22 (1996)
Femoral Fixation Interference screw
Interference screw
Interference screw (33), button (2), button-screw combination (3) NR Interference screw Interference screw Interference screw
Interference screw/post (36), button (2)
NR Interference screw Interference screw Interference screw
Press fit
Screw and washer
NR
NR
Peterson et al.23 (2001) Siebold et al.24 (2003) Sun et al.26 (2009, KSSTA) Sun et al.25 (2009, Arthroscopy) Soft-tissue allograft Almqvist et al.31 (2009)
1 NR 1 1
BPTB BPTB BPTB BPTB
NR
Tibialis anterior, posterior
Endoscopic
Lawhorn et al.27 (2012) Lee et al.32 (2010)
5 1
Tibialis anterior Tibialis anterior
Endoscopic Endoscopic
NR
Tibialis anterior
NR
Doubled hamstring Doubled hamstring
Endoscopic
EndoButton (Smith & Nephew Endoscopy, Andover, MA) EndoButton
Endoscopic
EndoButton
Snow et al.28 (2010)
Sun et al.29 (2011)
1
Sun et al.30 (2012)
1
Tibial Fixation
Interference Interference Interference Interference
screw screw screw screw
Mitek anchors (DePuy Synthes, Warsaw, IN) Cross pin Cross pin
Interference Interference Interference Interference
screw screw screw screw
Interference screw and staple Screw and spiked washer Interference screw and staple Interference screw and staple Interference screw and staple Interference screw
BPTB, boneepatellar tendonebone; KSSTA, Knee Surgery, Sports Traumatology, Arthroscopy; NR, not reported.
grade, instrumented laxity, or overall IKDC score between the 2 allograft types.32 Failure Risk Across All Studies Clinical failure risk was determined using an algorithm described by Crawford et al.33 This standardized failure risk is defined by the following: grade 2þ or worse Lachman, grade 2þ or worse pivot shift, overall IKDC grade C or D, or instrumented laxity with a sideto-side difference greater than 5 mm. In addition, patients with ruptured grafts were not included in the data from 3 studies,16,21,22 and thus the patients with ruptured grafts were added to the clinical failure risk to produce a redefined cumulative failure risk. Six studies did not report the graft rupture risk.17,19,25,26,29,30 The redefined cumulative failure risk in patients with softtissue allografts is reported in Table 5. The pooled failure risk was 10.3% (95% confidence interval [CI],
4.5% to 18.1%) in the soft-tissue allograft group (Fig 2) and 15.2% (95% CI, 11.3% to 19.6%) in the BPTB allograft group (Fig 3). Laxity on Physical Examination Across All Studies Laxity on physical examination was determined with Lachman and pivot-shift testing at follow-up. Lachman testing was reported in 9 BPTB studies and 3 soft-tissue studies (Table 6). The pooled risk of a Lachman grade greater than 5 mm was 6.4% (95% CI, 1.7% to 13.7%) in the soft-tissue allograft group and 8.6% (95% CI, 6.3% to 11.2%) in the BPTB allograft group. Pivot-shift testing was reported in 9 BPTB studies and 4 soft-tissue studies (Table 7). The pooled risk of a grade 2 or 3 pivot shift was 1.4% (95% CI, 0.3% to 3.3%) in the soft-tissue allograft group and 4.1% (95% CI, 1.9% to 7.2%) in the BPTB allograft group.
5
ALLOGRAFT COMPARISON Table 4. Study Demographic Characteristics and Follow-Up
Author BPTB allograft Bach et al.16 (2005) Barrett et al.17 (2005) Barrett et al.18 (2010) Kleipool et al.21 (1998) Melberg and Indelicato19 (1993) Lee et al.32 (2010) Nin et al.20 (1996) Noyes and Barber-Westin22 (1996) Peterson et al.23 (2001) Siebold et al.24 (2003) Sun et al.26 (2009, KSSTA) Sun et al.25 (2009, Arthroscopy) Soft-tissue allograft Almqvist et al.31 (2009) Lawhorn et al.27 (2012) Lee et al.32 (2010) Snow et al.28 (2010) Sun et al.29 (2011) Sun et al.30 (2012)
No. of Patients
Mean Age (Range), yr
Mean Length of Follow-Up (Range), mo
Sex
3 5 7 6 5
55 55 53 69 53
39 (24-96) 47 (24-78) 84 (60-108)
NR 59 100
3 5 3
56 56 68
63 90 100 93
6 5 1 2
56 74 86 94
3 3 3 3 3 1
72 69 56 48 94 84
60 60 28
27.9 (13-60) 23 (16-32) 23 (14-51)
51 M and 9 F 34 M and 26 F NR
30 183 34 80
28 39.8 31.8 33
(15-55) (20-69) (19-64) (19-65)
19 M and 11 F 120 M and 63 F 22 M and 12 F 63 M and 17 F
62.5 39 27.3 67
50 48 153 64 95 38
25 33.3 28.6 27 31 31.7
(17-50) (16-53) (15-60) (16-55) (18-59) (21-56)
36 M and 14 F 38 M and 10 F 127 M and 26 F 33 M and 31 F 78 M and 17 F 31 M and 7 F
NR (120-144)y 24 34 (24-52) 44.5 (24-55) 95 (72-120) 42.1 (31-55)
M M M M M
and and and and and
38 18 48 19 26
F F F F F
Modified Coleman Methodology Score
66 100 70 92 43
41 47 28.1 28 25
21 20 30 17 67
Delphi Score
(26-170) (24-74) (9-194) (30-64) (24-51)
59* 38 78 36 93
(18-61) (40-58) (13-39) (14-43) (14-49)
% Follow-Up
51 36.4 62.7 46 30
(55-73) (24-74) (14-44) (50-96)
83.3 65.7 NR 87.7 91 97.4
BPTB, boneepatellar tendonebone; F, female; KSSTA, Knee Surgery, Sports Traumatology, Arthroscopy; M, male; NR, not reported. *One patient underwent bilateral ACL repairs (59 patients, 60 knees). y For average calculation, a follow-up time of 120 months was used.
Instrumented Laxity Across All Studies Laxity was measured with either a KT-1000 or KT2000 arthrometer (MEDmetric, San Diego, CA) in 10 BPTB studies and 5 soft-tissue studies (Table 8). The pooled risk of instrumented anteroposterior laxity greater than 5 mm was 4.4% (95% CI, 0.6% to 11.6%) in the soft-tissue allograft group and 4.9% (95% CI, 2.8% to 7.4%) in the BPTB allograft group. Overall IKDC Score Across All Studies Eight BPTB studies and 4 soft-tissue studies used the objective IKDC scoring system to describe the results of the ACL reconstruction as normal (A), nearly normal (B), abnormal (C), and severely abnormal (D) (Table 9). The pooled risk of having an overall IKDC score of C or D was 6.5% (95% CI, 2.4% to 12.4%) in the soft-tissue allograft group and 12.2% (95% CI, 9.3% to 15.3%) in the BPTB allograft group. Patient-Reported Outcome Scores Across All Studies Mean Lysholm scores at follow-up ranged from 88 to 90 in the soft-tissue allograft group and from 82 to 94 in the BPTB allograft group. Mean Tegner scores at followup ranged from 6.5 to 7.6 in the soft-tissue allograft group and from 4.1 to 7.6 in the BPTB allograft group (Table 10).
Discussion Although both BPTB and soft-tissue allografts are used in clinical practice, this systematic review identified only 1 study in the literature that directly compared these grafts. The study showed no significant differences in any outcome variable between the 2 grafts.32 Expansion of this systematic review to include the Level IV evidence available on this topic showed qualitatively similar findings to the 1 comparative study on this topic. By pooling data from all available studies of the outcomes of ACL reconstruction with nonirradiated allograft, we constructed 95% CIs for the risk of graft failure, increased knee anteroposterior and rotational laxity, and fair/poor overall IKDC scores. Although direct statistical comparison of these studies is precluded by potential differences in patient populations, the overlap between the calculated CIs lends support to the findings of the comparative study that the choice of nonirradiated allograft (soft tissue v BPTB) is likely not a major determinant of outcomes. There are additional studies in the literature comparing allograft types that were not included in our review because of the inclusion and exclusion criteria. A recent study by O’Brien et al.34 compared nonirradiated BPTB allografts with doubled tibialis anterior allografts in patients younger than 30 years. The study was a retrospective matched-pair comparison with 20
6
Table 5. Failure Risk Stated Rerupture Rate
Abnormal Lachman Grade
Abnormal Pivot-Shift Grade
Abnormal Instrumented Laxity
IKDC Overall Grade C or D
61 38 78 37 93
1/61 NR 12/78 1/37 NR
4/60 1/38 NR 5/36 10/93
1/60 1/38 NR 3/36 7/93
0/60 3/38 NR 2/36 4/93
0/60 5/38 NR 6/36 7/93
4/60 5/38 19/78 6/36 7/60
60 60 30
5/60 0/60 2/30
2/60 6/60 NR
2/60 6/60 NR
NR NR 1/28
7/60 9/60 6/28
10/93 (10.8%) 9/60 (15%) 6/28 (21.4%)
10/93 (10.8%) (95% CI, 5.3%-18.9%) 9/60 (15%) (95% CI, 7.1%-26.6%) 8/30 (26.7%) (95% CI, 12.3%-45.9%)
30 183 34 80
1/30 19/183 NR NR
3/30 NR 3/34 6/80
1/30 NR 0/34 0/80
0/30 8/164 3/34 6/80
NR 26/164 3/34 5/80
3/30 (10%) 45/183 (24.6%) 3/34 (8.8%) 6/80 (7.5%)
3/30 (10%) (95% CI, 2.1%-26.5%) 45/183 (24.6%) (95% CI, 18.5%-31.5%) 3/34 (8.8%) (95% CI, 1.9%-23.7%) 6/80 (7.5%) (95% CI, 2.8%-15.6%)
55 48 153 64 95 38
5/55 0/48 5/153 5/64 NR NR
NR NR 3/153 NR 8/95 4/38
NR 0/48 4/153 1/25 0/95 0/38
NR 0/48 NR 0/25 8/95 4/38
11/50 0/48 11/153 3/59 9/95 4/38
11/50 (22%) 0/48 (0%) 11/153 (7.2%) 8/64 (12.5%) 9/95 (9.5%) 4/38 (10.5%)
16/55 (29.1%) (95% CI, 17.6%-42.9%) 0/48 (0%) (95% CI, 0.0%-7.4%) 11/153 (7.2%) (95% CI, 3.6%-12.5%) 8/64 (12.5%) (95% CI, 5.6%-23.2%) 9/95 (9.5%) (95% CI, 4.4%-17.2%) 4/38 (10.5%) (95% CI, 2.9%-24.8%)
Clinical Failure* (6.7%) (13.2%) (24.4%) (16.7%) (11.7%)
Redefined Cumulative Failure Risk 5/61 5/38 19/78 7/37 7/60
(8.2%) (95% CI, 2.7%-18.1%) (13.2%) (95% CI, 4.4%-28.1%) (24.4%) (95% CI, 15.3%-35.4%) (18.9%) (95% CI, 8.0%-35.2%) (11.7%) (95% CI, 4.8%-22.6%)
BPTB, boneepatellar tendonebone; CI, confidence interval; IKDC, International Knee Documentation Committee; KSSTA, Knee Surgery, Sports Traumatology, Arthroscopy; NR, not reported. *Clinical failure risk as defined by Crawford et al.33
C. D. JOYCE ET AL.
Author BPTB allograft Bach et al.16 (2005) Barrett et al.17 (2005) Barrett et al.18 (2010) Kleipool et al.21 (1998) Melberg and Indelicato19 (1993) Lee et al.32 (2010) Nin et al.20 (1996) Noyes and Barber-Westin22 (1996) Peterson et al.23 (2001) Siebold et al.24 (2003) Sun et al.26 (2009, KSSTA) Sun et al.25 (2009, Arthroscopy) Soft-tissue allograft Almqvist et al.31 (2009) Lawhorn et al.27 (2012) Lee et al.32 (2010) Snow et al.28 (2010) Sun et al.29 (2011) Sun et al.30 (2012)
No. of Patients
7
ALLOGRAFT COMPARISON Table 6. Lachman Grade at Follow-Up
Fig 2. Forest plot showing risk of graft failure after anterior cruciate ligament reconstruction with soft-tissue allograft. The overall pooled risk of graft failure is 10.3% (95% confidence interval, 4.5% to 18.1%).
patients in each group; however, follow-up was less than 2 years. The authors showed no significant difference between the 2 grafts with respect to graft rupture risk or patient-reported outcomes. Noyes et al.35 studied BPTB allografts and fascia lata allografts in a prospective study that concluded that BPTB allografts had significantly lower anteroposterior displacement with KT-1000 testing than fascia lata allografts. There was no significant difference in the final rating between the 2 groups. No direct comparison was made between the 2 groups regarding physical examination findings or graft failure risk. The authors concluded that BPTB allografts were more effective at restoring anteroposterior translation than fascia lata grafts because of firmer fixation of the osseous portion of the graft. The BPTB patients from their study were included in a later study by Noyes and Barber-Westin22 with longer follow-up that is included in this review. The patients with fascia lata grafts were not included in this review.
Author BPTB allograft Bach et al.16 (2005) Barrett et al.17 (2005) Kleipool et al.21 (1998) Melberg and Indelicato19 (1993) Lee et al.32 (2010) Nin et al.20 (1996) Peterson et al.23 (2001) Sun et al.26 (2009, KSSTA) Sun et al.25 (2009, Arthroscopy) Soft-tissue allograft Lee et al.32 (2010) Sun et al.29 (2011) Sun et al.30 (2012)
Grade
No. of Patients
0
1
2
3
60 38 36 93 60 60 30 34 80
39 31 21 47 53 43 24 28 65
17 6 10 36 5 11 3 3 9
4 1 5 6 2 6 3 3 6
0 0 0 4 0 0 0 0 0
153 95 38
139 78 30
11 9 4
3 8 4
0 0 0
BPTB, boneepatellar tendonebone; KSSTA, Knee Surgery, Sports Traumatology, Arthroscopy.
One strength of our study is that it is the only systematic review comparing nonirradiated soft-tissue allografts with BPTB allografts in the literature. The findings of this study, including the estimated risks of failure and poor outcomes, may not apply when irradiated tissue is used for ACL reconstruction. A second strength is the standardized and comprehensive manner in which this review was conducted. Limitations The study does have significant limitations. One limitation is the relatively small number of studies reporting on soft-tissue allografts (6 studies) compared with BPTB allografts (12 studies), leading to the inclusion of more patients with BPTB allografts in this review. Furthermore, concomitant intra-articular injuries varied greatly among the studies, potentially altering the outcomes of Table 7. Pivot-Shift Grade at Follow-Up
Fig 3. Forest plot showing risk of graft failure after anterior cruciate ligament reconstruction with boneepatellar tendonebone allograft. The overall pooled risk of graft failure is 15.2% (95% confidence interval, 11.3% to 19.6%). (KSSTA, Knee Surgery, Sports Traumatology, Arthroscopy.)
Author BPTB allograft Bach et al.16 (2005) Barrett et al.17 (2005) Kleipool et al.21 (1998) Lee et al.32 (2010) Melberg and Indelicato19 (1993) Nin et al.20 (1996) Peterson et al.23 (2001) Sun et al.26 (2009, KSSTA) Sun et al.25 (2009, Arthroscopy) Soft-tissue allograft Lawhorn et al.27 (2012) Lee et al.32 (2010) Snow et al.28 (2010) Sun et al.29 (2011) Sun et al.30 (2012)
Grade
No. of Patients
0
1
2
3
60 38 36 60 93 60 30 34 80
54 34 28 53 63 43 25 31 74
5 3 5 5 23 11 4 3 6
0 1 3 2 7 6 1 0 0
1 0 0 0 0 0 0 0 0
48 153 25 95 38
44 137 18 87 34
4 12 6 8 4
0 4 1 0 0
0 0 0 0 0
BPTB, boneepatellar tendonebone; KSSTA, Knee Surgery, Sports Traumatology, Arthroscopy.
8
C. D. JOYCE ET AL.
Table 8. Instrumented Laxity Measurements
Table 10. Postoperative Patient-Reported Outcome Scores Side-to-Side Difference
Author BPTB allograft Bach et al.16 (2005) Barrett et al.17 (2005) Kleipool et al.21 (1998) Melberg and Indelicato19 (1993) Noyes and Barber-Westin22 (1996) Peterson et al.23 (2001) Siebold et al.24 (2003) Sun et al.26 (2009, KSSTA) Sun et al.25 (2009, Arthroscopy) Soft-tissue allograft Lawhorn et al.27 (2012) Snow et al.28 (2010) Sun et al.29 (2011) Sun et al.30 (2012)
No. of Patients
<3 mm
3-5 mm
>5 mm
60 38 36 93 28 30 164 34 80
57 33 27 80 23 22 107 29 67
3 2 7 9 4 8 49 2 7
0 3 2 4 1 0 8 3 6
48 25 95 38
43 15 78 32
5 10 9 2
0 0 8 4
NOTE. Instrumented laxity was measured with either a KT-1000 or KT-2000 arthrometer. BPTB, boneepatellar tendonebone; KSSTA, Knee Surgery, Sports Traumatology, Arthroscopy.
each study. The use of a random-effects model in the meta-analysis allows modeling of these differences, but the overall estimate of failure risk is dependent to some extent on these associated pathologies. The largest limitation is that only 1 comparative study was identified. The remaining studies are all case series, introducing multiple possible biases into the results if the 2 patient groups were directly compared because of many potential differences in the patient groups that cannot be controlled for. One such difference in the groups is that the soft-tissue allograft group had a significantly larger number of male patients. Previous work suggests that male patients may exhibit decreased laxity compared Table 9. Overall International Knee Documentation Committee Grade at Follow-Up
Author BPTB allograft Barrett et al.17 (2005) Kleipool et al.21 (1998) Melberg and Indelicato19 (1993) Lee et al.32 (2010) Nin et al.20 (1996) Siebold et al.24 (2003) Sun et al.26 (2009, KSSTA) Sun et al.25 (2009, Arthroscopy) Soft-tissue allograft Lawhorn et al.27 (2012) Lee et al.32 (2010) Sun et al.29 (2011) Sun et al.30 (2012)
Grade
No. of Patients
A
B
C
D
38 36 93 60 60 164 34 80
19 17 50 25 30 48 12 30
14 13 36 28 21 90 19 45
5 5 5 6 8 26 2 4
0 1 2 1 1 0 1 1
48 153 95 38
43 65 33 12
5 77 53 22
0 11 8 3
0 0 1 1
BPTB, boneepatellar tendonebone; KSSTA, Knee Surgery, Sports Traumatology, Arthroscopy.
Author BPTB allograft Bach et al.16 (2005) Barrett et al.17 (2005) Barrett et al.18 (2010) Kleipool et al.21 (1998) Peterson et al.23 (2001) Sun et al.26 (2009, KSSTA) Sun et al.25 (2009, Arthroscopy) Soft-tissue allograft Snow et al.28 (2010) Sun et al.29 (2011) Sun et al.30 (2012)
Lysholm Score
Tegner Score
82 17 91 83 94 90 91 8 91 6
6 4.1 5 5 5.4 7.5 7.6
88 90 8 90 7
6.5 7.6 7.3
NOTE. Data are presented as mean or mean SD. BPTB, boneepatellar tendonebone; KSSTA, Knee Surgery, Sports Traumatology, Arthroscopy.
with female patients after ACL reconstruction.36 The identification of only 1 comparative study in the literature on this subject should serve as a call for further comparative studies in this area.
Conclusions One comparative study showed no difference in results after ACL reconstruction with nonirradiated BPTB and soft-tissue allografts. Inclusion of case series in the analysis showed qualitatively similar outcomes with the 2 graft types.
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