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Arthroscopic Subacromial Spacer Implantation in Patients With Massive Irreparable Rotator Cuff Tears: Clinical and Radiographic Results of 39 Retrospectives Cases
Arthroscopic Subacromial Spacer Implantation in Patients With Massive Irreparable Rotator Cuff Tears: Clinical and Radiographic Results of 39 Retrospectives Cases Julien Deranlot, M.D., Olivier Herisson, M.D., Geoffroy Nourissat, M.D., Ph.D., David Zbili, M.D., Jean David Werthel, M.D., M.S., Marie Vigan, Ph.D., and Francois Bruchou, M.D.
Purpose: To evaluate the clinical and radiographic outcome of a biodegradable subacromial spacer in the treatment of massive irreparable rotator cuff tear. Methods: Between January 2011 and December 2014, all shoulders with symptomatic massive irreparable rotator cuff tears treated at our institution with arthroscopic implantation of a biodegradable subacromial spacer followed for at least 1 year were included in our series. Patients with osteoarthritis grade 3 in the Hamada classification were excluded. Outcome measures included pre- and postoperative, range of motion, Constant score, acromiohumeral distance, and Hamada classification on anteroposterior and lateral radiographs. Results: Thirtynine consecutive shoulders (37 patients) met the inclusion criteria. The mean age of patients was 69.8 (53-84) years. At the last follow-up (mean 32.8 12.4 months), range of motion was significantly increased for all patients in anterior elevation (from 130 to 160 , P ¼ .02), abduction (from 100 to 160 , P ¼ .01), and external rotation (from 30 to 45 , P ¼ .0001). The mean Constant score was also significantly (P < .001) improved from 44.8 (15.2) preoperatively to 76.0 (17.1) at the last follow-up. The mean acromiohumeral distance significantly (P ¼ .002) decreased from 8.2 mm (3.4) to 6.2 mm (3.1) at the last follow-up. The Hamada score progressed of 1 radiographic stage in 4 shoulders (15%) and progressed of 3 stages in 2 (4%), whereas the other 32 shoulders remained stable. No intra- or postoperative complications were found except for 1 patient who required a revision for spacer migration. Conclusions: Arthroscopic implantation of a subacromial spacer for irreparable rotator cuff tear leads to significant improvement in shoulder function at a minimum of 1 year postoperatively. Level of Evidence: Level IV, therapeutic case series; treatment study.
N
umerous treatments have been proposed for the management of patients with symptomatic irreparable rotator cuff tears. Treatment choice depends on age, tolerance of pain, dysfunction, and functional demand. Medical treatment and rehabilitation should always be considered before any surgical treatment.1
From Clinique Drouot (J.D., M.V.); Clinique Groupe Maussins (J.D., O.H., G.N.), Paris; Hôpitaux Universitaires Paris Ile-de-France Ouest, Université de Versailles Saint-Quentin-en-Yvelines (D.Z., J.D.W.), Boulogne-Billancourt; and Hôpital Privée de l’Ouest Parisien Groupe OrthoWest (F.B.), Trappes, France. The authors report that they have no conflicts of interest in the authorship and publication of this article. Received October 10, 2016; accepted March 31, 2017. Address correspondence to Julien Deranlot, M.D., Clinique Drouot, 20 rue Laffitte, 75009 Paris, France. E-mail: [email protected] Ó 2017 by the Arthroscopy Association of North America 0749-8063/16930/$36.00 http://dx.doi.org/10.1016/j.arthro.2017.03.029
However, when this has failed, many different surgical procedures have been described including acromial decompression with biceps tenotomy or tenodesis, partial cuff repair, tendon transfer, tendon allograft, synthetic patch, superior capsule reconstruction, or reverse shoulder arthroplasty.2-14 Currently, there is no guideline to manage massive irreparable cuff tear, and since 2012 several authors have described the implantation of a biodegradable subacromial spacer into the subacromial space in this indication.14,15 The subacromial spacer has been designed to create a physical barrier between tissues in the subacromial space and keep the humeral head down when the cuff is not efficient to facilitate deltoid action. However, the literature is limited concerning the clinical results, and only one prospective study has been published with satisfactory clinical outcomes.16 The purpose of this retrospective study was to evaluate the clinical and radiographic outcome of a
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biodegradable subacromial spacer in the treatment of massive irreparable rotator cuff tear. Our hypothesis was that a biodegradable subacromial spacer would be a safe and reproducible procedure providing a significant functional improvement for irreparable rotator cuff tear with no arthritis.
Methods Study Design Between January 2011 and December 2014, all patients who had undergone arthroscopic implantation of a biodegradable subacromial spacer were included. The exclusion criterion was an osteoarthritis >3 in the Hamada classification. A subscapularis tear was a contraindication because it may lead to a risk of anterior migration of the spacer. The decision to perform surgery was made after failure of nonoperative treatment and rehabilitation for at least 6 months. The indication for arthroscopic implantation of a subacromial spacer was: all patients who came at our institution between January 2011 and December 2014 for a symptomatic and irreparable rotator cuff tear with tendon retraction (Patte > stage 2 in the Patte classification),17 fatty infiltration of muscles (Goutallier 3),18 no osteoarthritis (
Postoperative Protocol Patients were placed in a sling with passive and active motion exercises started on the day after surgery. Functional Evaluation The same operating surgeon examined all patients preoperatively. Two independent orthopaedic shoulder surgeons examined patients postoperatively. The Constant score and the range of motion were measured during the preoperative clinical examination.20 Active abduction and external rotation were measured in degrees. Internal rotation was recorded. The Constant score was adjusted for age and gender. Postoperatively, the clinical evaluation included range of motion and Constant score.21,22 Radiographic Evaluation Shoulder anteroposterior and lateral radiographs were performed for all patients preoperatively and at the last follow-up. The radiologic evaluation was performed by a senior osteoarticular radiologist. Postoperative radiographs were taken at the time of the last follow-up of the patient. The morphology of the acromion was assessed preoperatively according to the Bigliani classification.23 All patients underwent a preoperative computed tomographic arthrography or magnetic resonance imaging to evaluate rotator cuff retraction in the frontal plane according to the Patte17 classification and fatty infiltration according to the Goutallier classification.18 Acromiohumeral distances and Hamada classification24 were assessed pre- and postoperatively. Statistical Analysis Continuous variables are summarized in mean and standard deviation and categorical in percentages. Student’s t-tests or Wilcoxon tests for the paired sample were used to compare mean depending on the sample size. Chi-squared tests were performed to test for categorical variables. P values were assessed at the .05 level. Considering the results, we performed a subgroup analysis (post hoc) to identify differences according to the status of the long head biceps tendon. All statistical analyses were performed with SAS software, version 9.4 (SAS Institute, Cary, NC). Assuming that differences in Constant score pre- and postoperatively would exceed the minimal of 10,12 power analysis indicated that a minimum sample size of 32 patients was required to establish significant differences with statistical power of 0.95 (alpha ¼ 5%).
Results Thirty-seven consecutive patients (39 shoulders) with a massive irreparable rotator cuff tear underwent arthroscopic implantation of a biodegradable subacromial space. The average follow-up was
3
ARTHROSCOPIC SUBACROMIAL SPACER IMPLANTATION
Anatomic Lesions Intraoperative biceps findings are summarized in Table 2. Thirty-seven shoulders had a stage 3 frontal retraction according to the Patte classification. Twenty-one shoulders had an isolated tear of the supraspinatus tendon and 18 had tendon tears of both the supraspinatus and the infraspinatus. Twenty-seven shoulders had a stage 3, 2 had a stage 2, and 10 had a stage 4 fatty infiltration according to the Goutallier classification.
Fig 1. Schematic representation of the spacer deployment (step 1: arthroscopic evaluation, step 2: selection of the correct subacromial spacer size, step 3: insertion and inflation with saline solution, step 4: stability assessment) and the peroperative view once the spacer inflates (view through the spacer).
32.8 months (12.4). The average age of the subjects at the time of surgery was 69.8 (53-84) years. Sociodemographic data are summarized in Table 1. One patient required a revision procedure for spacer migration at 3 months. This patient was treated by revision surgery with a new arthroscopic subacromial spacer replacement. The latest adjusted Constant score for this patient was 63 after 36 months of follow-up.
Table 1. Baseline Characteristics of Patients: Social Demographics, Paraclinic Evaluation Gender, n (%) Female Male Age at operation (y), mean (SD) Occupation, n (%) Retired Manual work Sedentary work Operated limb, n (%) Right Left Bilateral Retraction, n (%) Stage 2 Stage 3 Sagittal extension, n (%) Supraspinatus Supra and infraspinatus Goutallier fatty infiltration, n (%) Stage 2 Stage 3 Stage 4 Hamada classification, n (%) Stage 1 Stage 2 Stage 5 SD, standard deviation.
22 (59.5) 15 (40.5) 69.8 (7.9) 31 (81.8) 1 (2.6) 6 (15.8) 27 (73.0) 8 (21.6) 2 (5.4) 1 (2.6) 37 (97.4) 20 (52.6) 18 (47.4) 2 (5.1) 26 (68.4) 10 (26.3) 24 (77.4) 6 (19.4) 1 (2.6)
Clinical Outcome At the last follow-up, range of motion was significantly increased for all patients in anterior elevation (P ¼ .02), abduction (P ¼ .01), and external rotation (P ¼ .0001). Clinical results are detailed in Table 3. Functional Results The mean preoperative Constant score was 40 (14.6). The mean preoperative adjusted Constant score was 45 (15.2). At 1-year follow-up, the mean Constant score was improved to 59 (13.7), and at the last follow-up, the mean Constant score and adjusted Constant score were significantly improved to 64 (13.6) (P < .0001) and 76 (17.1), respectively (Fig 2). A significant improvement occurred between the 1-year follow-up and the 3-year follow-up regarding the adjusted Constant score (P ¼ .02). The last follow-up adjusted Constant score was excellent (>100 points) for 3 shoulders (9%), good (86-99 points) for 8 (23%), fair (65-85 points) for 16 (45%), and poor (<65 points) for 8 shoulders (23%). All items of the Constant score were significantly improved (Table 4). Spontaneous preoperative rupture of the tendon of the long head of the biceps did not influence significantly the postoperative Constant score (P ¼ .2). Radiographic Results The preoperative radiological assessment is summarized in Table 1. At the last follow-up, the mean acromiohumeral distance significantly decreased from 8.2 to 6.2 mm (P ¼ .002). The mean acromiohumeral distance difference was 2.1 mm (3.2). Concerning the Hamada score, 4 patients progressed of 1 radiographic stage (15%) and 1 patient progressed of 3 stages (4%). Table 2. Peroperative Biceps Tendon Evaluation Long head of the biceps tendon, n (%) Prerupture Rupture Hypertrophy Subluxation
2 3 11 23
(5.1) (7.7) (28.2) (59)
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Table 3. Preoperative and Postoperative Clinical and Radiographic Outcome
Table 4. Preoperative and Postoperative Constant Score Preoperative
Clinical outcome Anterior elevation Abduction External rotation Radiographic evaluation Acromiohumeral distance
Preoperative
3-Year Follow-up
P Value
124 (48) 113 (53) 32 (19)
14 (35) 136 (43) 52 (25)
.02 .01 .0001
8 (3)
6 (3)
.002
NOTE. Values are presented as mean (standard deviation). P values of Student’s t-tests or Wilcoxon tests for a paired sample.
Spontaneous preoperative rupture of the tendon of the long head of the biceps did not influence significantly the postoperative acromiohumeral distance (P ¼ .4).
Discussion The most important finding of this study is that a subacromial spacer is a safe and reproducible procedure that leads to significant functional improvement in patients with massive irreparable rotator cuff tear with no arthritis. The definition of massive tears is controversial. Cofield25 described them as tears >5 cm in length. Gerber et al.11 described them as tears involving 2 or more tendons although some authors restricted this definition to tears of more than 2 tendons.26,27 The rotator cuff reparability is determined by several factors that typically include acromiohumeral distance, frontal retraction according to the Patte classification, and fatty infiltration of the muscle. Many palliative interventions are possible for patients with symptomatic massive irreparable rotator cuff tear, but there is no surgical guideline to treat this population. Tenotomy of the long head of the biceps tendon is probably the safer and less aggressive surgical treatment to address symptoms in patients with massive irreparable rotator cuff tear.2-5 Partial repair or tendon transfers such as the latissimus dorsi transfer or more recently the lower trapezius transfer could be satisfactory therapeutic
Pain Activities of daily living Range of motion Strength Total
4 5 26 3 39
(3) (3) (10) (3) (14)
Postoperative 8 15 34 7 64
(1) (4) (7) (4) (14)
P Value <.0001 <.0001 .0003 <.0001 <.0001
NOTE. Values are presented as mean (standard deviation). P values of Student’s t-tests or Wilcoxon tests for a paired sample.
options.10,12,28-30 However, prospective randomized studies comparing those procedures with isolated biceps tenotomy are limited. Tuberoplasty could also be a surgical option, but the procedure has not been validated.31,32 Mihata et al.14 recently described an alternative for the irreparable cuff tears with a superior capsular reconstruction. In their study, the American Shoulder and Elbow Score was significantly improved from 23.5 to 92.9. Active range of motions was significantly improved for active anterior elevation and external rotation. However, this procedure requiring an autograft with fascia lata increases the morbidity of the procedure (donor site). More recently, alternatives have been developed with allograft or xenograft with interesting results.33,34 Recently, arthroscopic subacromial spacer implantation has been proposed to restore a pain-free functional shoulder function.16 Concerning the functional outcome, the results of this study are in agreement with the study of Senekovic et al.16 In their study, the Constant score showed statistically significant improvement with 68.8% of the patients who had an improvement of at least 25 points. Walch et al.5 reported results of 307 open biceps tenotomy. At a mean 57-month follow-up, the adjusted Constant score increased by an average of 25.3 points with a final score of 88.9. Boileau et al.4 reported the results of 39 tenotomies versus 33 tenodesis. At a mean 35-month follow-up, the mean Constant score increased by an average of 20 points with an average final score of 66.5. The results did not significantly differ between the 2 groups.
Fig 2. Boxplot repartition for (A) Constant and (B) adjusted Constant score: pre- and postoperative measures.
ARTHROSCOPIC SUBACROMIAL SPACER IMPLANTATION
The mean acromiohumeral distance was found to decrease significantly in this study. In addition, 22 shoulders had no deterioration according to the Hamada radiographic classification. The average reduction in acromiohumeral distance between the pre- and postoperative evaluation was 2.1 mm, which is more than what has been reported by Walch et al.5 and by Boileau et al.4 after tenotomy or tenodesis of the biceps. Therefore, in comparison, subacromial spacers were found to have less satisfactory radiographic results in this study. This retrospective study showed an improvement of the functional outcome, which seems to remain stable over time. Those results are similar to what has been reported for isolated tenotomy. In addition, the preoperative status of the long head biceps tendon did not influence significantly the postoperative Constant score (P ¼ .2).
2.
3.
4.
5.
Limitations There are some limitations of this study. First, this is a retrospective study that entails in it all the limitations of a retrospective study, Secondly, the number of patients is limited, even if we consider only massive irreparable cuff tear. Thirdly, clinical and radiographic data assessment was performed by a single examiner, and the preoperative assessment was performed by the surgeon, exposing to a measurement bias. However, the reliability of these measurements was improved by the use of standardized and validated assessment tools. Finally, there was a high rate of isolated irreparable supraspinatus tears in our series. Irreparability was assessed by the surgeon according to the fatty infiltration and to his intraoperative ability to fix the tendon on the footprint without any tension. The subacromial spacer appears to be a safe and reliable procedure for irreparable rotator cuff tear with a low rate of complication, even when the tendon of the long head of the biceps is already spontaneously torn. At a mean 3-year follow-up, results are encouraging and close to those obtained after tenotomy or tenodesis of the long head of the biceps, except for abduction and external rotation that seem to be more significantly improved by the spacer. Longer follow-up is mandatory to confirm this clinical difference and to confirm that the radiological modifications observed in this study are stable over time.
10.
Conclusions
15.
Arthroscopic implantation of a subacromial spacer for irreparable rotator cuff tears leads to significant improvement in shoulder function at a minimum of 1-year postoperatively.
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References 1. Levy O, Mullett H, Roberts S, Copeland S. The role of anterior deltoid reeducation in patients with massive
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irreparable degenerative rotator cuff tears. J Shoulder Elbow Surg 2008;17:863-870. Berth A, Neumann W, Awiszus F, Pap G. Massive rotator cuff tears: Functional outcome after debridement or arthroscopic partial repair. J Orthop Traumatol 2010;11: 13-20. Moser M, Jablonski MV, Horodyski M, Wright TW. Functional outcome of surgically treated massive rotator cuff tears: A comparison of complete repair, partial repair, and debridement. Orthopedics 2007;30:479-482. Boileau P, Baqué F, Valerio L, Ahrens P, Chuinard C, Trojani C. Isolated arthroscopic biceps tenotomy or tenodesis improves symptoms in patients with massive irreparable rotator cuff tears. J Bone Joint Surg Am 2007;89:747-757. Walch G, Edwards TB, Boulahia A, Nové-Josserand L, Neyton L, Szabo I. Arthroscopic tenotomy of the long head of the biceps in the treatment of rotator cuff tears: Clinical and radiographic results of 307 cases. J Shoulder Elbow Surg 2005;14:238-246. Scheibel M, Lichtenberg S, Habermeyer P. Reversed arthroscopic subacromial decompression for massive rotator cuff tears. J Shoulder Elbow Surg 2004;13:272-278. Aoki M, Okamura K, Fukushima S, Takahashi T, Ogino T. Transfer of latissimus dorsi for irreparable rotator-cuff tears. J Bone Joint Surg Br 1996;78:761-766. Augereau B, Apoil A. [Repair using a deltoid flap of an extensive loss of substance of the rotary cuff of the shoulder]. Rev Chir Orthop Reparatrice Appar Mot 1988;74: 298-301 [in French]. Birmingham PM, Neviaser RJ. Outcome of latissimus dorsi transfer as a salvage procedure for failed rotator cuff repair with loss of elevation. J Shoulder Elbow Surg 2008;17:871-874. Burkhart SS, Nottage WM, Ogilvie-Harris DJ, Kohn HS, Pachelli A. Partial repair of irreparable rotator cuff tears. Arthroscopy 1994;10:363-370. Gerber C, Fuchs B, Hodler J. The results of repair of massive tears of the rotator cuff. J Bone Joint Surg Am 2000;82:505-515. Gerber C, Maquieira G, Espinosa N. Latissimus dorsi transfer for the treatment of irreparable rotator cuff tears. J Bone Joint Surg Am 2006;88:113-120. Habermeyer P, Magosch P, Rudolph T, Lichtenberg S, Liem D. Transfer of the tendon of latissimus dorsi for the treatment of massive tears of the rotator cuff: A new single-incision technique. J Bone Joint Surg Br 2006;88: 208-212. Mihata T, Lee TQ, Watanabe C, et al. Clinical results of arthroscopic superior capsule reconstruction for irreparable rotator cuff tears. Arthroscopy 2013;29:459-470. Savarese E, Romeo R. New solution for massive, irreparable rotator cuff tears: The subacromial “biodegradable spacer”. Arthrosc Tech 2012;1:e69-e74. Senekovic V, Poberaj B, Kovacic L, Mikek M, Adar E, Dekel A. Prospective clinical study of a novel biodegradable sub-acromial spacer in treatment of massive irreparable rotator cuff tears. Eur J Orthop Surg Traumatol 2013;23:311-316. Patte D. Classification of rotator cuff lesions. Clin Orthop 1990;254:81-86.
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18. Goutallier D, Postel JM, Bernageau J, Lavau L, Voisin MC. Fatty muscle degeneration in cuff ruptures. Pre- and postoperative evaluation by CT scan. Clin Orthop 1994;304: 78-83. 19. Hamada K, Yamanaka K, Uchiyama Y, Mikasa T, Mikasa M. A radiographic classification of massive rotator cuff tear arthritis. Clin Orthop 2011;469:2452-2456. 20. Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop 1987;214:160-164. 21. Hudak PL, Amadio PC, Bombardier C. Development of an upper extremity outcome measure: The DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG). Am J Ind Med 1996;29:602-608. 22. Godfrey J, Hamman R, Lowenstein S, Briggs K, Kocher M. Reliability, validity, and responsiveness of the simple shoulder test: Psychometric properties by age and injury type. J Shoulder Elbow Surg 2007;16:260-267. 23. Bigliani LU, Ticker JB, Flatow EL, Soslowsky LJ, Mow VC. The relationship of acromial architecture to rotator cuff disease. Clin Sports Med 1991;10:823-838. 24. Hamada K, Fukuda H, Mikasa M, Kobayashi Y. Roentgenographic findings in massive rotator cuff tears. A longterm observation. Clin Orthop 1990;254:92-96. 25. Cofield RH. Rotator cuff disease of the shoulder. J Bone Joint Surg Am 1985;67:974-979. 26. Fossati C, Arrigoni P, Ragone V, et al. How do massive immobile rotator cuff tears behave after arthroscopic interval slides? Comparison with mobile tears. Joints 2014;2:66-70. 27. Iagulli ND, Field LD, Hobgood ER, Ramsey JR, Savoie FH. Comparison of partial versus complete arthroscopic repair
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of massive rotator cuff tears. Am J Sports Med 2012;40: 1022-1026. Omid R, Heckmann N, Wang L, McGarry MH, Vangsness CT, Lee TQ. Biomechanical comparison between the trapezius transfer and latissimus transfer for irreparable posterosuperior rotator cuff tears. J Shoulder Elbow Surg 2015;24: 1635-1643. Elhassan BT, Wagner ER, Werthel J-D. Outcome of lower trapezius transfer to reconstruct massive irreparable posterior-superior rotator cuff tear. J Shoulder Elbow Surg 2016;25:1346-1353. Gerber C, Vinh TS, Hertel R, Hess CW. Latissimus dorsi transfer for the treatment of massive tears of the rotator cuff. A preliminary report. Clin Orthop 1988;232:51-61. Fenlin JM, Chase JM, Rushton SA, Frieman BG. Tuberoplasty: Creation of an acromiohumeral articulationda treatment option for massive, irreparable rotator cuff tears. J Shoulder Elbow Surg 2002;11:136-142. Verhelst L, Vandekerckhove P-J, Sergeant G, Liekens K, Van Hoonacker P, Berghs B. Reversed arthroscopic subacromial decompression for symptomatic irreparable rotator cuff tears: Mid-term follow-up results in 34 shoulders. J Shoulder Elbow Surg 2010;19:601-608. Gupta AK, Hug K, Boggess B, Gavigan M, Toth AP. Massive or 2-tendon rotator cuff tears in active patients with minimal glenohumeral arthritis: Clinical and radiographic outcomes of reconstruction using dermal tissue matrix xenograft. Am J Sports Med 2013;41:872-879. Gupta AK, Hug K, Berkoff DJ. Dermal tissue allograft for the repair of massive irreparable rotator cuff tears. Am J Sports Med 2012;40:141-147.
Purpose: To evaluate the clinical and radiographic outcome of a biodegradable subacromial spacer in the treatment of massive irreparable rotator cuff tear. Methods: Between January 2011 and December 2014, all shoulders with symptomatic massive irreparable rotator cuff tears treated at our institution with arthroscopic implantation of a biodegradable subacromial spacer followed for at least 1 year were included in our series. Patients with osteoarthritis grade 3 in the Hamada classification were excluded. Outcome measures included pre- and postoperative, range of motion, Constant score, acromiohumeral distance, and Hamada classification on anteroposterior and lateral radiographs. Results: Thirtynine consecutive shoulders (37 patients) met the inclusion criteria. The mean age of patients was 69.8 (53-84) years. At the last follow-up (mean 32.8 12.4 months), range of motion was significantly increased for all patients in anterior elevation (from 130 to 160 , P ¼ .02), abduction (from 100 to 160 , P ¼ .01), and external rotation (from 30 to 45 , P ¼ .0001). The mean Constant score was also significantly (P < .001) improved from 44.8 (15.2) preoperatively to 76.0 (17.1) at the last follow-up. The mean acromiohumeral distance significantly (P ¼ .002) decreased from 8.2 mm (3.4) to 6.2 mm (3.1) at the last follow-up. The Hamada score progressed of 1 radiographic stage in 4 shoulders (15%) and progressed of 3 stages in 2 (4%), whereas the other 32 shoulders remained stable. No intra- or postoperative complications were found except for 1 patient who required a revision for spacer migration. Conclusions: Arthroscopic implantation of a subacromial spacer for irreparable rotator cuff tear leads to significant improvement in shoulder function at a minimum of 1 year postoperatively. Level of Evidence: Level IV, therapeutic case series; treatment study.
N
umerous treatments have been proposed for the management of patients with symptomatic irreparable rotator cuff tears. Treatment choice depends on age, tolerance of pain, dysfunction, and functional demand. Medical treatment and rehabilitation should always be considered before any surgical treatment.1
From Clinique Drouot (J.D., M.V.); Clinique Groupe Maussins (J.D., O.H., G.N.), Paris; Hôpitaux Universitaires Paris Ile-de-France Ouest, Université de Versailles Saint-Quentin-en-Yvelines (D.Z., J.D.W.), Boulogne-Billancourt; and Hôpital Privée de l’Ouest Parisien Groupe OrthoWest (F.B.), Trappes, France. The authors report that they have no conflicts of interest in the authorship and publication of this article. Received October 10, 2016; accepted March 31, 2017. Address correspondence to Julien Deranlot, M.D., Clinique Drouot, 20 rue Laffitte, 75009 Paris, France. E-mail: [email protected] Ó 2017 by the Arthroscopy Association of North America 0749-8063/16930/$36.00 http://dx.doi.org/10.1016/j.arthro.2017.03.029
However, when this has failed, many different surgical procedures have been described including acromial decompression with biceps tenotomy or tenodesis, partial cuff repair, tendon transfer, tendon allograft, synthetic patch, superior capsule reconstruction, or reverse shoulder arthroplasty.2-14 Currently, there is no guideline to manage massive irreparable cuff tear, and since 2012 several authors have described the implantation of a biodegradable subacromial spacer into the subacromial space in this indication.14,15 The subacromial spacer has been designed to create a physical barrier between tissues in the subacromial space and keep the humeral head down when the cuff is not efficient to facilitate deltoid action. However, the literature is limited concerning the clinical results, and only one prospective study has been published with satisfactory clinical outcomes.16 The purpose of this retrospective study was to evaluate the clinical and radiographic outcome of a
Arthroscopy: The Journal of Arthroscopic and Related Surgery, Vol
-,
No
-
(Month), 2017: pp 1-6
1
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J. DERANLOT ET AL.
biodegradable subacromial spacer in the treatment of massive irreparable rotator cuff tear. Our hypothesis was that a biodegradable subacromial spacer would be a safe and reproducible procedure providing a significant functional improvement for irreparable rotator cuff tear with no arthritis.
Methods Study Design Between January 2011 and December 2014, all patients who had undergone arthroscopic implantation of a biodegradable subacromial spacer were included. The exclusion criterion was an osteoarthritis >3 in the Hamada classification. A subscapularis tear was a contraindication because it may lead to a risk of anterior migration of the spacer. The decision to perform surgery was made after failure of nonoperative treatment and rehabilitation for at least 6 months. The indication for arthroscopic implantation of a subacromial spacer was: all patients who came at our institution between January 2011 and December 2014 for a symptomatic and irreparable rotator cuff tear with tendon retraction (Patte > stage 2 in the Patte classification),17 fatty infiltration of muscles (Goutallier 3),18 no osteoarthritis (
Postoperative Protocol Patients were placed in a sling with passive and active motion exercises started on the day after surgery. Functional Evaluation The same operating surgeon examined all patients preoperatively. Two independent orthopaedic shoulder surgeons examined patients postoperatively. The Constant score and the range of motion were measured during the preoperative clinical examination.20 Active abduction and external rotation were measured in degrees. Internal rotation was recorded. The Constant score was adjusted for age and gender. Postoperatively, the clinical evaluation included range of motion and Constant score.21,22 Radiographic Evaluation Shoulder anteroposterior and lateral radiographs were performed for all patients preoperatively and at the last follow-up. The radiologic evaluation was performed by a senior osteoarticular radiologist. Postoperative radiographs were taken at the time of the last follow-up of the patient. The morphology of the acromion was assessed preoperatively according to the Bigliani classification.23 All patients underwent a preoperative computed tomographic arthrography or magnetic resonance imaging to evaluate rotator cuff retraction in the frontal plane according to the Patte17 classification and fatty infiltration according to the Goutallier classification.18 Acromiohumeral distances and Hamada classification24 were assessed pre- and postoperatively. Statistical Analysis Continuous variables are summarized in mean and standard deviation and categorical in percentages. Student’s t-tests or Wilcoxon tests for the paired sample were used to compare mean depending on the sample size. Chi-squared tests were performed to test for categorical variables. P values were assessed at the .05 level. Considering the results, we performed a subgroup analysis (post hoc) to identify differences according to the status of the long head biceps tendon. All statistical analyses were performed with SAS software, version 9.4 (SAS Institute, Cary, NC). Assuming that differences in Constant score pre- and postoperatively would exceed the minimal of 10,12 power analysis indicated that a minimum sample size of 32 patients was required to establish significant differences with statistical power of 0.95 (alpha ¼ 5%).
Results Thirty-seven consecutive patients (39 shoulders) with a massive irreparable rotator cuff tear underwent arthroscopic implantation of a biodegradable subacromial space. The average follow-up was
3
ARTHROSCOPIC SUBACROMIAL SPACER IMPLANTATION
Anatomic Lesions Intraoperative biceps findings are summarized in Table 2. Thirty-seven shoulders had a stage 3 frontal retraction according to the Patte classification. Twenty-one shoulders had an isolated tear of the supraspinatus tendon and 18 had tendon tears of both the supraspinatus and the infraspinatus. Twenty-seven shoulders had a stage 3, 2 had a stage 2, and 10 had a stage 4 fatty infiltration according to the Goutallier classification.
Fig 1. Schematic representation of the spacer deployment (step 1: arthroscopic evaluation, step 2: selection of the correct subacromial spacer size, step 3: insertion and inflation with saline solution, step 4: stability assessment) and the peroperative view once the spacer inflates (view through the spacer).
32.8 months (12.4). The average age of the subjects at the time of surgery was 69.8 (53-84) years. Sociodemographic data are summarized in Table 1. One patient required a revision procedure for spacer migration at 3 months. This patient was treated by revision surgery with a new arthroscopic subacromial spacer replacement. The latest adjusted Constant score for this patient was 63 after 36 months of follow-up.
Table 1. Baseline Characteristics of Patients: Social Demographics, Paraclinic Evaluation Gender, n (%) Female Male Age at operation (y), mean (SD) Occupation, n (%) Retired Manual work Sedentary work Operated limb, n (%) Right Left Bilateral Retraction, n (%) Stage 2 Stage 3 Sagittal extension, n (%) Supraspinatus Supra and infraspinatus Goutallier fatty infiltration, n (%) Stage 2 Stage 3 Stage 4 Hamada classification, n (%) Stage 1 Stage 2 Stage 5 SD, standard deviation.
22 (59.5) 15 (40.5) 69.8 (7.9) 31 (81.8) 1 (2.6) 6 (15.8) 27 (73.0) 8 (21.6) 2 (5.4) 1 (2.6) 37 (97.4) 20 (52.6) 18 (47.4) 2 (5.1) 26 (68.4) 10 (26.3) 24 (77.4) 6 (19.4) 1 (2.6)
Clinical Outcome At the last follow-up, range of motion was significantly increased for all patients in anterior elevation (P ¼ .02), abduction (P ¼ .01), and external rotation (P ¼ .0001). Clinical results are detailed in Table 3. Functional Results The mean preoperative Constant score was 40 (14.6). The mean preoperative adjusted Constant score was 45 (15.2). At 1-year follow-up, the mean Constant score was improved to 59 (13.7), and at the last follow-up, the mean Constant score and adjusted Constant score were significantly improved to 64 (13.6) (P < .0001) and 76 (17.1), respectively (Fig 2). A significant improvement occurred between the 1-year follow-up and the 3-year follow-up regarding the adjusted Constant score (P ¼ .02). The last follow-up adjusted Constant score was excellent (>100 points) for 3 shoulders (9%), good (86-99 points) for 8 (23%), fair (65-85 points) for 16 (45%), and poor (<65 points) for 8 shoulders (23%). All items of the Constant score were significantly improved (Table 4). Spontaneous preoperative rupture of the tendon of the long head of the biceps did not influence significantly the postoperative Constant score (P ¼ .2). Radiographic Results The preoperative radiological assessment is summarized in Table 1. At the last follow-up, the mean acromiohumeral distance significantly decreased from 8.2 to 6.2 mm (P ¼ .002). The mean acromiohumeral distance difference was 2.1 mm (3.2). Concerning the Hamada score, 4 patients progressed of 1 radiographic stage (15%) and 1 patient progressed of 3 stages (4%). Table 2. Peroperative Biceps Tendon Evaluation Long head of the biceps tendon, n (%) Prerupture Rupture Hypertrophy Subluxation
2 3 11 23
(5.1) (7.7) (28.2) (59)
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Table 3. Preoperative and Postoperative Clinical and Radiographic Outcome
Table 4. Preoperative and Postoperative Constant Score Preoperative
Clinical outcome Anterior elevation Abduction External rotation Radiographic evaluation Acromiohumeral distance
Preoperative
3-Year Follow-up
P Value
124 (48) 113 (53) 32 (19)
14 (35) 136 (43) 52 (25)
.02 .01 .0001
8 (3)
6 (3)
.002
NOTE. Values are presented as mean (standard deviation). P values of Student’s t-tests or Wilcoxon tests for a paired sample.
Spontaneous preoperative rupture of the tendon of the long head of the biceps did not influence significantly the postoperative acromiohumeral distance (P ¼ .4).
Discussion The most important finding of this study is that a subacromial spacer is a safe and reproducible procedure that leads to significant functional improvement in patients with massive irreparable rotator cuff tear with no arthritis. The definition of massive tears is controversial. Cofield25 described them as tears >5 cm in length. Gerber et al.11 described them as tears involving 2 or more tendons although some authors restricted this definition to tears of more than 2 tendons.26,27 The rotator cuff reparability is determined by several factors that typically include acromiohumeral distance, frontal retraction according to the Patte classification, and fatty infiltration of the muscle. Many palliative interventions are possible for patients with symptomatic massive irreparable rotator cuff tear, but there is no surgical guideline to treat this population. Tenotomy of the long head of the biceps tendon is probably the safer and less aggressive surgical treatment to address symptoms in patients with massive irreparable rotator cuff tear.2-5 Partial repair or tendon transfers such as the latissimus dorsi transfer or more recently the lower trapezius transfer could be satisfactory therapeutic
Pain Activities of daily living Range of motion Strength Total
4 5 26 3 39
(3) (3) (10) (3) (14)
Postoperative 8 15 34 7 64
(1) (4) (7) (4) (14)
P Value <.0001 <.0001 .0003 <.0001 <.0001
NOTE. Values are presented as mean (standard deviation). P values of Student’s t-tests or Wilcoxon tests for a paired sample.
options.10,12,28-30 However, prospective randomized studies comparing those procedures with isolated biceps tenotomy are limited. Tuberoplasty could also be a surgical option, but the procedure has not been validated.31,32 Mihata et al.14 recently described an alternative for the irreparable cuff tears with a superior capsular reconstruction. In their study, the American Shoulder and Elbow Score was significantly improved from 23.5 to 92.9. Active range of motions was significantly improved for active anterior elevation and external rotation. However, this procedure requiring an autograft with fascia lata increases the morbidity of the procedure (donor site). More recently, alternatives have been developed with allograft or xenograft with interesting results.33,34 Recently, arthroscopic subacromial spacer implantation has been proposed to restore a pain-free functional shoulder function.16 Concerning the functional outcome, the results of this study are in agreement with the study of Senekovic et al.16 In their study, the Constant score showed statistically significant improvement with 68.8% of the patients who had an improvement of at least 25 points. Walch et al.5 reported results of 307 open biceps tenotomy. At a mean 57-month follow-up, the adjusted Constant score increased by an average of 25.3 points with a final score of 88.9. Boileau et al.4 reported the results of 39 tenotomies versus 33 tenodesis. At a mean 35-month follow-up, the mean Constant score increased by an average of 20 points with an average final score of 66.5. The results did not significantly differ between the 2 groups.
Fig 2. Boxplot repartition for (A) Constant and (B) adjusted Constant score: pre- and postoperative measures.
ARTHROSCOPIC SUBACROMIAL SPACER IMPLANTATION
The mean acromiohumeral distance was found to decrease significantly in this study. In addition, 22 shoulders had no deterioration according to the Hamada radiographic classification. The average reduction in acromiohumeral distance between the pre- and postoperative evaluation was 2.1 mm, which is more than what has been reported by Walch et al.5 and by Boileau et al.4 after tenotomy or tenodesis of the biceps. Therefore, in comparison, subacromial spacers were found to have less satisfactory radiographic results in this study. This retrospective study showed an improvement of the functional outcome, which seems to remain stable over time. Those results are similar to what has been reported for isolated tenotomy. In addition, the preoperative status of the long head biceps tendon did not influence significantly the postoperative Constant score (P ¼ .2).
2.
3.
4.
5.
Limitations There are some limitations of this study. First, this is a retrospective study that entails in it all the limitations of a retrospective study, Secondly, the number of patients is limited, even if we consider only massive irreparable cuff tear. Thirdly, clinical and radiographic data assessment was performed by a single examiner, and the preoperative assessment was performed by the surgeon, exposing to a measurement bias. However, the reliability of these measurements was improved by the use of standardized and validated assessment tools. Finally, there was a high rate of isolated irreparable supraspinatus tears in our series. Irreparability was assessed by the surgeon according to the fatty infiltration and to his intraoperative ability to fix the tendon on the footprint without any tension. The subacromial spacer appears to be a safe and reliable procedure for irreparable rotator cuff tear with a low rate of complication, even when the tendon of the long head of the biceps is already spontaneously torn. At a mean 3-year follow-up, results are encouraging and close to those obtained after tenotomy or tenodesis of the long head of the biceps, except for abduction and external rotation that seem to be more significantly improved by the spacer. Longer follow-up is mandatory to confirm this clinical difference and to confirm that the radiological modifications observed in this study are stable over time.
10.
Conclusions
15.
Arthroscopic implantation of a subacromial spacer for irreparable rotator cuff tears leads to significant improvement in shoulder function at a minimum of 1-year postoperatively.
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