- Email: [email protected]
interposition arthroplasty—A case series with functional outcomes
The Foot 21 (2011) 119–123
Contents lists available at ScienceDirect
The Foot journal homepage: www.elsevier.com/locate/foot
Gelfoam first metatarsophalangeal replacement/interposition arthroplasty—A case series with functional outcomes Eyal Heller, Dror Robinson ∗ Foot and Ankle Service, Department of Orthopedics, Hasharon Hospital, Rabin Medical Center, Keren Kayemet 7, Petah Tikwa, Israel1
a r t i c l e
i n f o
Article history: Received 25 July 2010 Received in revised form 11 November 2010 Accepted 30 November 2010 Keywords: Great toe Hallux rigidus, metatarsal Total joint replacement Interposition arthroplasty, foot surgery
a b s t r a c t Reported below are the functional results of a case-series of Gelfoam® -based first metatarsophalangeal total joint replacements using an interposition arthroplasty technique carried out between April 1997 and December 2007. All patients who underwent Gelfoam-based arthroplasty under the care of a single surgeon were included; outcome scores and complications were recorded. A total of 31 joints in 31 consecutive patients were followed for a mean duration of 64 (range 24–150) months, and the mean patient age at the time of operation was 48 ± 9 (range 35–80) years. Hallux rigidus was the primary diagnosis in all of the cases except one in which a failed chevron ostetomy was the indication for treatment. The mean American Orthopaedic Foot & Ankle Society Hallux-Metatarsophalangeal-Interphalangeal score increased from an average of 35 pre-operatively to an average of 74 at final follow-up (range 67–100), with 20 (64.5%) joints rated good to excellent. One (3.5%) joint was fused 6 months after the arthroplasty procedure. Based on these results, we concluded that first MTPJ total joint GelfoamTM -based interpostion arthroplasty is a cheap alternative to other joint replacement systems for the MTP joint. The results appear similar to those achieved using more expensive devices. © 2011 Elsevier Ltd. All rights reserved.
Osteoarthritis of the first MTP joint leads to limitation of joint motion. First line therapy is conservative consisting of rockerbottom soles. In some cases operation is necessary. Limited MTP motion leads to inefficient toe-off phase of gait. The optimal operation is one that results in painless joint with normal range of movement, normal toe length, and restores normal gait pattern. Most of the operative procedures available today do not achieve these goals. Operative procedures can be divided into joint motion preserving procedures and joint obliterating procedures such as arthrodesis. Cheilectomy alone is reserved for less severe joint destruction [1], Keller’s arthroplasty with capsular interposition [2] often leads to an unstable and floppy toe. A realignment decompression osteotomy often leads to pain relief and improved joint motion, particularly in cases where metatarsal elevation is an important pathological finding [3]. However, in some cases the pain remains due to the lack of cartilage covering of the joint surfaces. This is a common finding in hallux rigidus, however joint space deterioration is not necessarily symptomatic [4].
∗ Corresponding author. E-mail address: [email protected] (D. Robinson). 1 Affiliated with Tel Aviv University Sackler School of Medicine. 0958-2592/$ – see front matter © 2011 Elsevier Ltd. All rights reserved. doi:10.1016/j.foot.2010.11.007
While fusion is considered the gold standard treatment of severe hallux rigidus it is associated with loss of foot function and abnormal gait [5]. Interposition arthroplasty is considered an innovative procedure, whose main advantage appears to be that it does not burn any bridges. Joint replacement surgery or fusion are still a viable alternative following this procedure. Valenti’s interposition arthroplasty involves insertion of soft tissues into the denuded joint surfaces [6,7]. It is useful for stage I–II hallux rigidus. The current procedure describes a similar technique, that can be applied in any stage of hallux rigidus and enhances fibrocartilage formation in the newly created joint space. This procedure can be used in conjunction with osteotomy of the first metatarsus, and has been used by us during the last two decades. First MTPJ mobility not only allows a normal gait pattern and action of the windlass mechanism, but also is desirable in many cases to allow fashionable footwear to be worn. In such cases, fusion of the joint might be less desirable. It is known that arthrodesis of the first MTPJ can significantly decrease step length [8].
1. Materials and methods All patients who underwent a first MTPJ Gelfoam® (absorbable gelatin powder, Pharmacia & Upjohn Co., Division of Pfizer Inc., New York, NY 10017 [9]) interposition arthroplasty, under the care of a single specialist foot and ankle orthopaedic surgeon (DR) were included in the series. Patients were selected to undergo a first
120
E. Heller, D. Robinson / The Foot 21 (2011) 119–123
Fig. 2. In another patient, adequate exposure is achieved using the dorsomedial incision. The medialization of the incision prevents the risk of long toe extensor entrapment by the skin sutures.
of the medical record during the course of each patient’s treatment, and then retrospectively collated. The functional scores were obtained in an outpatient setting with interviews to complete the AOFAS-HMI score conducted by one of the authors. Scores and examination findings were procured postoperatively and the results recorded before commencement of this investigation, for which the data were collated retrospectively for the purpose of this study. Preoperative AOFAS-HMI scores were obtained for this series of patients, and the stage of hallux limitus/rigidus was recorded. All patients were available for at least three years followup. In order to minimize radiation exposure repeated radiographs were not performed in asymptomatic or minimally symptomatic patients. 1.1. Operative technique
Fig. 1. (a) A representative 72-year-old patient. The joint is subluxed with clinically stage 3 hallux rigidus and abducto hallux valgus with severe pronation deformity. (b) The intermetatarsal angle was 18◦ , the hallux valgus angle was 65◦ . The oblique view indicates that the joint is subluxed also in the sagittal plane.
MTPJ arthroplasty if they were diagnosed with hallux rigidus that had failed conservative treatment and when given the operative options of arthrodesis or joint motion preserving operation, opted for motion preservation. Patients with failed primary surgery were also given the option of arthrodesis or revision arthroplasty if the bone quality could support the Gelfoam implant. Patients would be excluded if the bone stock was not sufficient or the collaterals were obviously destroyed as determined by radiographic evaluation (7 patients were excluded for this reason and are not included in the analysis). Inclusion criteria were patients with hallux rigidus of the first MTPJ suffering with limited movement and pain who had failed conservative treatment; operations were carried out between January 1997 and December 2007. Patients were followed-up initially at 2 weeks for wound assessment, at 6 months, and then annually. At each follow-up, clinical examination, and functional scores were taken and after six months and two years a standing radiograph was performed. Anteroposterior (AP) and lateral standing radiographs were assessed quantitatively for gross malalignment, hallux valgus angle, intermetatarsal angle and joint space (Fig. 1). Feet were scored using the American Orthopaedic Foot and Ankle Society (AOFAS) hallux metatarsophalangeal–interphalangeal (HMI) 100-point scale [10]. Data were prospectively collected as part
A tourniquet was used for most patients and placed at the proximal calf level and inflated to 250 mm Hg. A dorso-medial approach was used over the first MTPJ with retraction of the extensor hallucis longus and placement of a dorsal capsular incision to expose the metatarsal head and the base of the proximal phalanx (Fig. 2). The hallux was not dislocated and capsular attachments preserved in particular the collateral ligaments (Fig. 3). Synovectomy was perfomed using sharp dissection. The osteophytes were removed as well as any bunion. The cartilage surfaces are removed accept for areas that appear completely normal in the joint. Once the bone ends were removed, microfracture of the joint surfaces was performed by malleting a 1.8 mm Kirshner wire. Then Gelfoam
Fig. 3. The joint space appears completely obliterated. Note that the collateral ligament is intact though inferiorly displaced and barely visible at the bottom of the photograph.
E. Heller, D. Robinson / The Foot 21 (2011) 119–123
121
Table 1 Distribution of AOFAS-HMIa scale scores (N = 31 patients). Variable
Student’s t-test
Pre-operative Count (%)
Pain (0–40 points) Function (0–10 points) Footwear requirements (0–10) Restriction of MTPJ motion (0–10) Restriction of IPJ motion (0–5) MTPJ–IPJ stability (0–5) Callus related to MTPJ and/or IPJ (0–5) Alignment (0–15)
p < 0.01 p < 0.05 p > 0.05 p > 0.05 p > 0.05 p > 0.05 p < 0.05 p < 0.01
8 2 2 3 5 5 2 8
± ± ± ± ± ± ± ±
8 5 4 3 1 2 2 3
Post-operative Count (%) 32 7 5 6 5 5 4 15
± ± ± ± ± ± ± ±
11 3 2 4 1 1 1 3
From Kitaoka et al. [10]. IPJ, interphalangeal joint; MTPJ, metatarsophalangeal joint. a American Orthopaedic Foot & Ankle Society Hallux-Metatarsophalangeal-Interphalangeal score (minimum score 0, worst outcome; maximum score 100, best outcome).
ington, WV 25701, USA [12]) and transitioned to full weight bearing after 4 weeks. 2. Results
Fig. 4. The joint space is restored after osteophytectomy and bunionectomy as well as minimal proximal phalanx resection. The collateral ligament position is restored following a base osteomtomy of the first metatarsus.
sponge was packed into the joint cavity. Typically, the joint was overstuffed to allow for muscular and fibrous tightening during the postoperative period while still maintaining great toe length. Closure was then performed in anatomical layers using Vicryl® (Ethicon Inc., Somerville, NJ) 2–0 sutures for the subcutaneous tissue and 4–0 Prolene® (Ethicon Inc., Somerville, NJ) sutures for the skin. The wound was dressed with chlorhexidine-soaked gauze, and a wool and crepe bandage. No cast splint was used in these cases (nowadays we routinely use the DARCO TASTM -Toe Alignment Splint [11]). Patients initially walked in a heel weight-bearing orthotic shoe (Orthowedge, DARCO International, Inc., 810 Memorial Blvd., Hunt-
Fig. 5. Gelfoam® interposition arthroplasty prior to wound closure.
A total of 31 first MTPJ Gelfoam arthroplasties were undertaken in 31 patients, performed between January 1997 and December 2007, and none of the patients were lost to follow-up. All of the patients were included in the results with a mean follow-up of 55 (range 24–134 months). Of the 31 patients, 24 (74%) patients, were male, and 7 (26%), were female. The operations were carried out on 15 (48%) left and 16 (52%) right first MTPJs. The mean age of the patients at the time of the operation was 48 ± 9 (range 35–80) years. Indications for the operation included 30 (96%) hallux rigidus in 9 cases combined with hallux valgus, 1 (4%) patient who needed a revision of prior first MTPJ surgery. Preoperative hallux rididus grading [13] was performed in all patients. There were 25 grade 3 patients, 4 grade 4 patients and 1 grade 2 patients. One patient had previous chevron osteotomy performed due to a mistaken diagnosis of hallux valgus rather than hallux rigidus and valgus. Despite good realignment of the hallux, due to persistent pain, she had to be revised.
Fig. 6. While joint range of motion is improved over the preoperative range, and the patient is pain-free, the limited joint range of motion appears to be the major drawback of the Gelfoam® interposition arthroplasty technique. In this case 15◦ of plantar flexion and 25◦ of dorsiflesion.
122
E. Heller, D. Robinson / The Foot 21 (2011) 119–123
Fig. 7. Pre-operative versus post-operative radiographs, demonstrate improved joint space following arthroplasty (in this case combined with a distal metatarsal osteotomy to correct the hallux abducto valgus deformity). The lateral radiographs taken in maximal active great toe dorsiflexion, allow appreciation of the improvement in active dorsiflexion following the procedure.
The average score and standard deviations of in each subcategory of the AOFAS-HMI scale of patients can be seen in Table 1. The mean pre-operative score was 35 ± 8 (the median average score was 38) and the mean last follow-up postoperative AOFAS-HMI score was 74 ± 12 points, and the median average score was 78. In this series, 24 (77%) of the patients achieved greater than 30◦ range of motion (ROM), and 2 (6.4%) achieved 75◦ or more. We also asked the patient to grade pre-operatively and postoperatively their condition on a 4 point scale (excellent, good, medium, poor). Pre-operatively all patients graded their condition as poor (otherwise they would not have opted for surgery), while post-operatively 9 patients graded as excellent, 11 patients as good and 9 patients graded their condition as medium. Only patient continued to grade her situation as poor (Figs. 4–6). Radiographic evaluation indicated an increase of joint space from 1 ± 1 mm preoperatively to 3 ± 1 mm post-operatively (Fig. 7). In no patient was gross malalignment present. The hallux valgus angle decreased from 33 ± 4◦ to 18 ± 6◦ (the difference was statistically significant). The intermetatarasal angle (IMA) remained
similar during the follow-up period (11 ± 3◦ versus 7 ± 4◦ ). In some cases where a proximal base osteotomy was performed (5 out of 31), the IMA decreased from a pre-operative mean IMA of 14 ± 6◦ to 10 ± 4◦ . There are too few cases to allow subgroup analysis. There is minimal shortening of the first metatarsal using this procedure because length lost by the arthroplasty procedure is regained using the spacer that increases the joint space. The single case available for histological evaluation (see Fig. 8) appears to indicate that the spacer is replaced by fibrous tissue adhering to the bone. One female patient who had constant pain not related to activity and stiffness (pre-operative AOFAS-HMI 23, and post-operative AOFAS-HMI 20) required an arthrodesis with bone graft owing to constant pain. After the operation her function did not improve and her pain score remained maximal. Histological analysis confirmed fibro-arthrosis in the joint without an inflammatory component (Fig. 8). In summary, 3 (10%) of the cases were associated with postoperative complications, 1 (3.13%) case of neuroma in scar resolved after one year of pain, 1 case (3%) had to be revised as described
E. Heller, D. Robinson / The Foot 21 (2011) 119–123
123
[15]. It is known that PDGF release from platelets encourages fibrocartilage repair of chondral lesions. The spongy physical properties of the gelatin sponge enhance clot formation and provide structural support for the forming clot [9]. We were able to achieve 100% follow-up, and there was observed a two-fold AOFAS-HMI score improvement. Our postoperative AOFAS-HMI scores compare well with prior publications that focus on first MTPJ total joint replacement with similar follow-up periods and patient numbers using the AOFAS-HMI scale [16–18]. Most points were lost because of pain and limitations of the range of joint movement. It should be explained to the patients that full range of motion or complete pain relief are not a realistic prospect. Financial disclosure
Fig. 8. Histological evaluation of a retrieved Gelfoam® arthroplasty, reveals fibrosis, with some giant cells but no inflammatory cells in close proximity to living trabecular bone (original magnification 60×, H&E stain).
above, and in one case limited active toe extension was suspected to be due to EHL tendon entrapment, but it was not revised. 3. Discussion Our study focused on functional outcomes and complications associated with GelfoamTM arthroplasty. Gelfoam is a medical device intended for application to bleeding surfaces as a hemostatic. It is a water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified pork skin gelatin. When it is saturated with sterile sodium chloride solution, it is indicated in surgical procedures, including those involving cancellous bone bleeding, as a hemostatic device. It is our experience that in order to achieve collateral tightness while restricting the amount of material packed into the joint, it is better not to immerse the product in water, but to insert it in dry. The product gets rapidly soaked in blood, even when a tourniquet is used. Gelfoam should be used sparingly according to the manufacturers instructions [9]. This is partly due to the unusual risk of infection, and this procedure should not be used in the presence of known infection. The suitability of Gelfoam for this procedure is dependent on two properties that have previously been the cause of complications related to its use. One property is its tendency to swell. This has previously caused neural damage when used after laminectomy in close proximity to the neural elements [9]. Gelfoam should not be packed into bony cavities as it might cause pressure-necrosis. We have not observed such a complication in our series. This is perhaps due to the lack of tight capsular suturing employed in this series. The upside of this swelling tendency is the ability of the implant to maintain joint spacing. The other property of Gelfoam is its tendency to encourage fibrosis. It has been reported to cause tendon fibrosis following tendon suturing. The mechanism of action of surface-mediated hemostatic devices is supportive and mechanical. Surface acting devices, when applied directly to bleeding surfaces, arrest bleeding by forming a clot. Steadman et al. have shown that such “super” clot encourages fibrocartilage repair of the joint [14]. Jenkins and Senz have suggested that the clotting effect of Gelfoam may be due to thromboplastin release from platelets
The authors have received no benefits or grants related to this study. Conflict of interest None reported. References [1] Wagenmann B, Schuh R, Trnka HJ. Functional outcome of cheilectomy for the treatment of hallux rigidus. Z Orthop Unfall 2010. [2] Hahn MP, Gerhardt N, Thordarson DB. Medial capsular interpositional arthroplasty for severe hallux rigidus. Foot Ankle Int 2009;30:494–9. [3] Malerba F, Milani R, Sartorelli E, Haddo O. Distal oblique first metatarsal osteotomy in grade 3 hallux rigidus: a long-term followup. Foot Ankle Int 2008;29:677–82. [4] Smith RW, Katchis SD, Ayson LC. Outcomes in hallux rigidus patients treated nonoperatively: a long-term follow-up study. Foot Ankle Int 2000;21: 906–13. [5] Brage ME, Ball ST. Surgical options for salvage of end-stage hallux rigidus. Foot Ankle Clin 2002;7:49–73. [6] Saxena A. The Valenti procedure for hallux limitus/rigidus. J Foot Ankle Surg 1995;34:485–8. [7] Saxena A. Valenti arthroplasty. J Foot Ankle Surg 1996;35:86–7. [8] DeFrino PF, Brodsky JW, Pollo FE, Crenshaw SJ, Beischer AD. First metatarsophalangeal arthrodesis: a clinical, pedobarographic and gait analysis study. Foot Ankle Int 2002;23:496–502. [9] Gelfoam® , absorbable gelatin powder (absorbable gelatin powder from absorbable gelatin sponge, USP); 2010. http://www.pfizer.com/files/products/ uspi gelfoam powder.pdf. [10] Kitaoka HB, Alexander IJ, Adelaar RS, Nunley JA, Myerson MS, Sanders M. Clinical rating systems for the ankle–hindfoot, midfoot, hallux, and lesser toes. Foot Ankle Int 1994;15:349–53. [11] DARCO TASTM -Toe Alignment Splint; 2010. http://www.darcointernational. com/tas. OrthoWedgeTM ; [12] DARCO 2010. http://www.darcointernational.com/ orthowedge. [13] Coughlin MJ, Shurnas PS. Hallux rigidus. Grading and long-term results of operative treatment. J Bone Joint Surg Am 2003;85-A:2072–88. [14] Steadman JR, Rodkey WG, Rodrigo JJ. Microfracture: surgical technique and rehabilitation to treat chondral defects. Clin Orthop Relat Res 2001:S362–9. [15] Jenkin HP, Senz E. Control of arterial hemorrhage by a gelatin sponge cuff and chromic surgical gut sheath; a new experimental method. Arch Surg 1947;55:637–49. [16] Arbuthnot JE, Cheung G, Balain B, Denehey T, Higgins G, Trevett MC. Replacement arthroplasty of the first metatarsophalangeal joint using a ceramic-coated endoprosthesis for the treatment of hallux rigidus. J Foot Ankle Surg 2008;47:500–4. [17] Fuhrmann RA, Wagner A, Anders JO. First metatarsophalangeal joint replacement: the method of choice for end-stage hallux rigidus? Foot Ankle Clin 2003;8:711–21, vi. [18] Pulavarti RS, McVie JL, Tulloch CJ. First metatarsophalangeal joint replacement using the bio-action great toe implant: intermediate results. Foot Ankle Int 2005;26:1033–7.
Contents lists available at ScienceDirect
The Foot journal homepage: www.elsevier.com/locate/foot
Gelfoam first metatarsophalangeal replacement/interposition arthroplasty—A case series with functional outcomes Eyal Heller, Dror Robinson ∗ Foot and Ankle Service, Department of Orthopedics, Hasharon Hospital, Rabin Medical Center, Keren Kayemet 7, Petah Tikwa, Israel1
a r t i c l e
i n f o
Article history: Received 25 July 2010 Received in revised form 11 November 2010 Accepted 30 November 2010 Keywords: Great toe Hallux rigidus, metatarsal Total joint replacement Interposition arthroplasty, foot surgery
a b s t r a c t Reported below are the functional results of a case-series of Gelfoam® -based first metatarsophalangeal total joint replacements using an interposition arthroplasty technique carried out between April 1997 and December 2007. All patients who underwent Gelfoam-based arthroplasty under the care of a single surgeon were included; outcome scores and complications were recorded. A total of 31 joints in 31 consecutive patients were followed for a mean duration of 64 (range 24–150) months, and the mean patient age at the time of operation was 48 ± 9 (range 35–80) years. Hallux rigidus was the primary diagnosis in all of the cases except one in which a failed chevron ostetomy was the indication for treatment. The mean American Orthopaedic Foot & Ankle Society Hallux-Metatarsophalangeal-Interphalangeal score increased from an average of 35 pre-operatively to an average of 74 at final follow-up (range 67–100), with 20 (64.5%) joints rated good to excellent. One (3.5%) joint was fused 6 months after the arthroplasty procedure. Based on these results, we concluded that first MTPJ total joint GelfoamTM -based interpostion arthroplasty is a cheap alternative to other joint replacement systems for the MTP joint. The results appear similar to those achieved using more expensive devices. © 2011 Elsevier Ltd. All rights reserved.
Osteoarthritis of the first MTP joint leads to limitation of joint motion. First line therapy is conservative consisting of rockerbottom soles. In some cases operation is necessary. Limited MTP motion leads to inefficient toe-off phase of gait. The optimal operation is one that results in painless joint with normal range of movement, normal toe length, and restores normal gait pattern. Most of the operative procedures available today do not achieve these goals. Operative procedures can be divided into joint motion preserving procedures and joint obliterating procedures such as arthrodesis. Cheilectomy alone is reserved for less severe joint destruction [1], Keller’s arthroplasty with capsular interposition [2] often leads to an unstable and floppy toe. A realignment decompression osteotomy often leads to pain relief and improved joint motion, particularly in cases where metatarsal elevation is an important pathological finding [3]. However, in some cases the pain remains due to the lack of cartilage covering of the joint surfaces. This is a common finding in hallux rigidus, however joint space deterioration is not necessarily symptomatic [4].
∗ Corresponding author. E-mail address: [email protected] (D. Robinson). 1 Affiliated with Tel Aviv University Sackler School of Medicine. 0958-2592/$ – see front matter © 2011 Elsevier Ltd. All rights reserved. doi:10.1016/j.foot.2010.11.007
While fusion is considered the gold standard treatment of severe hallux rigidus it is associated with loss of foot function and abnormal gait [5]. Interposition arthroplasty is considered an innovative procedure, whose main advantage appears to be that it does not burn any bridges. Joint replacement surgery or fusion are still a viable alternative following this procedure. Valenti’s interposition arthroplasty involves insertion of soft tissues into the denuded joint surfaces [6,7]. It is useful for stage I–II hallux rigidus. The current procedure describes a similar technique, that can be applied in any stage of hallux rigidus and enhances fibrocartilage formation in the newly created joint space. This procedure can be used in conjunction with osteotomy of the first metatarsus, and has been used by us during the last two decades. First MTPJ mobility not only allows a normal gait pattern and action of the windlass mechanism, but also is desirable in many cases to allow fashionable footwear to be worn. In such cases, fusion of the joint might be less desirable. It is known that arthrodesis of the first MTPJ can significantly decrease step length [8].
1. Materials and methods All patients who underwent a first MTPJ Gelfoam® (absorbable gelatin powder, Pharmacia & Upjohn Co., Division of Pfizer Inc., New York, NY 10017 [9]) interposition arthroplasty, under the care of a single specialist foot and ankle orthopaedic surgeon (DR) were included in the series. Patients were selected to undergo a first
120
E. Heller, D. Robinson / The Foot 21 (2011) 119–123
Fig. 2. In another patient, adequate exposure is achieved using the dorsomedial incision. The medialization of the incision prevents the risk of long toe extensor entrapment by the skin sutures.
of the medical record during the course of each patient’s treatment, and then retrospectively collated. The functional scores were obtained in an outpatient setting with interviews to complete the AOFAS-HMI score conducted by one of the authors. Scores and examination findings were procured postoperatively and the results recorded before commencement of this investigation, for which the data were collated retrospectively for the purpose of this study. Preoperative AOFAS-HMI scores were obtained for this series of patients, and the stage of hallux limitus/rigidus was recorded. All patients were available for at least three years followup. In order to minimize radiation exposure repeated radiographs were not performed in asymptomatic or minimally symptomatic patients. 1.1. Operative technique
Fig. 1. (a) A representative 72-year-old patient. The joint is subluxed with clinically stage 3 hallux rigidus and abducto hallux valgus with severe pronation deformity. (b) The intermetatarsal angle was 18◦ , the hallux valgus angle was 65◦ . The oblique view indicates that the joint is subluxed also in the sagittal plane.
MTPJ arthroplasty if they were diagnosed with hallux rigidus that had failed conservative treatment and when given the operative options of arthrodesis or joint motion preserving operation, opted for motion preservation. Patients with failed primary surgery were also given the option of arthrodesis or revision arthroplasty if the bone quality could support the Gelfoam implant. Patients would be excluded if the bone stock was not sufficient or the collaterals were obviously destroyed as determined by radiographic evaluation (7 patients were excluded for this reason and are not included in the analysis). Inclusion criteria were patients with hallux rigidus of the first MTPJ suffering with limited movement and pain who had failed conservative treatment; operations were carried out between January 1997 and December 2007. Patients were followed-up initially at 2 weeks for wound assessment, at 6 months, and then annually. At each follow-up, clinical examination, and functional scores were taken and after six months and two years a standing radiograph was performed. Anteroposterior (AP) and lateral standing radiographs were assessed quantitatively for gross malalignment, hallux valgus angle, intermetatarsal angle and joint space (Fig. 1). Feet were scored using the American Orthopaedic Foot and Ankle Society (AOFAS) hallux metatarsophalangeal–interphalangeal (HMI) 100-point scale [10]. Data were prospectively collected as part
A tourniquet was used for most patients and placed at the proximal calf level and inflated to 250 mm Hg. A dorso-medial approach was used over the first MTPJ with retraction of the extensor hallucis longus and placement of a dorsal capsular incision to expose the metatarsal head and the base of the proximal phalanx (Fig. 2). The hallux was not dislocated and capsular attachments preserved in particular the collateral ligaments (Fig. 3). Synovectomy was perfomed using sharp dissection. The osteophytes were removed as well as any bunion. The cartilage surfaces are removed accept for areas that appear completely normal in the joint. Once the bone ends were removed, microfracture of the joint surfaces was performed by malleting a 1.8 mm Kirshner wire. Then Gelfoam
Fig. 3. The joint space appears completely obliterated. Note that the collateral ligament is intact though inferiorly displaced and barely visible at the bottom of the photograph.
E. Heller, D. Robinson / The Foot 21 (2011) 119–123
121
Table 1 Distribution of AOFAS-HMIa scale scores (N = 31 patients). Variable
Student’s t-test
Pre-operative Count (%)
Pain (0–40 points) Function (0–10 points) Footwear requirements (0–10) Restriction of MTPJ motion (0–10) Restriction of IPJ motion (0–5) MTPJ–IPJ stability (0–5) Callus related to MTPJ and/or IPJ (0–5) Alignment (0–15)
p < 0.01 p < 0.05 p > 0.05 p > 0.05 p > 0.05 p > 0.05 p < 0.05 p < 0.01
8 2 2 3 5 5 2 8
± ± ± ± ± ± ± ±
8 5 4 3 1 2 2 3
Post-operative Count (%) 32 7 5 6 5 5 4 15
± ± ± ± ± ± ± ±
11 3 2 4 1 1 1 3
From Kitaoka et al. [10]. IPJ, interphalangeal joint; MTPJ, metatarsophalangeal joint. a American Orthopaedic Foot & Ankle Society Hallux-Metatarsophalangeal-Interphalangeal score (minimum score 0, worst outcome; maximum score 100, best outcome).
ington, WV 25701, USA [12]) and transitioned to full weight bearing after 4 weeks. 2. Results
Fig. 4. The joint space is restored after osteophytectomy and bunionectomy as well as minimal proximal phalanx resection. The collateral ligament position is restored following a base osteomtomy of the first metatarsus.
sponge was packed into the joint cavity. Typically, the joint was overstuffed to allow for muscular and fibrous tightening during the postoperative period while still maintaining great toe length. Closure was then performed in anatomical layers using Vicryl® (Ethicon Inc., Somerville, NJ) 2–0 sutures for the subcutaneous tissue and 4–0 Prolene® (Ethicon Inc., Somerville, NJ) sutures for the skin. The wound was dressed with chlorhexidine-soaked gauze, and a wool and crepe bandage. No cast splint was used in these cases (nowadays we routinely use the DARCO TASTM -Toe Alignment Splint [11]). Patients initially walked in a heel weight-bearing orthotic shoe (Orthowedge, DARCO International, Inc., 810 Memorial Blvd., Hunt-
Fig. 5. Gelfoam® interposition arthroplasty prior to wound closure.
A total of 31 first MTPJ Gelfoam arthroplasties were undertaken in 31 patients, performed between January 1997 and December 2007, and none of the patients were lost to follow-up. All of the patients were included in the results with a mean follow-up of 55 (range 24–134 months). Of the 31 patients, 24 (74%) patients, were male, and 7 (26%), were female. The operations were carried out on 15 (48%) left and 16 (52%) right first MTPJs. The mean age of the patients at the time of the operation was 48 ± 9 (range 35–80) years. Indications for the operation included 30 (96%) hallux rigidus in 9 cases combined with hallux valgus, 1 (4%) patient who needed a revision of prior first MTPJ surgery. Preoperative hallux rididus grading [13] was performed in all patients. There were 25 grade 3 patients, 4 grade 4 patients and 1 grade 2 patients. One patient had previous chevron osteotomy performed due to a mistaken diagnosis of hallux valgus rather than hallux rigidus and valgus. Despite good realignment of the hallux, due to persistent pain, she had to be revised.
Fig. 6. While joint range of motion is improved over the preoperative range, and the patient is pain-free, the limited joint range of motion appears to be the major drawback of the Gelfoam® interposition arthroplasty technique. In this case 15◦ of plantar flexion and 25◦ of dorsiflesion.
122
E. Heller, D. Robinson / The Foot 21 (2011) 119–123
Fig. 7. Pre-operative versus post-operative radiographs, demonstrate improved joint space following arthroplasty (in this case combined with a distal metatarsal osteotomy to correct the hallux abducto valgus deformity). The lateral radiographs taken in maximal active great toe dorsiflexion, allow appreciation of the improvement in active dorsiflexion following the procedure.
The average score and standard deviations of in each subcategory of the AOFAS-HMI scale of patients can be seen in Table 1. The mean pre-operative score was 35 ± 8 (the median average score was 38) and the mean last follow-up postoperative AOFAS-HMI score was 74 ± 12 points, and the median average score was 78. In this series, 24 (77%) of the patients achieved greater than 30◦ range of motion (ROM), and 2 (6.4%) achieved 75◦ or more. We also asked the patient to grade pre-operatively and postoperatively their condition on a 4 point scale (excellent, good, medium, poor). Pre-operatively all patients graded their condition as poor (otherwise they would not have opted for surgery), while post-operatively 9 patients graded as excellent, 11 patients as good and 9 patients graded their condition as medium. Only patient continued to grade her situation as poor (Figs. 4–6). Radiographic evaluation indicated an increase of joint space from 1 ± 1 mm preoperatively to 3 ± 1 mm post-operatively (Fig. 7). In no patient was gross malalignment present. The hallux valgus angle decreased from 33 ± 4◦ to 18 ± 6◦ (the difference was statistically significant). The intermetatarasal angle (IMA) remained
similar during the follow-up period (11 ± 3◦ versus 7 ± 4◦ ). In some cases where a proximal base osteotomy was performed (5 out of 31), the IMA decreased from a pre-operative mean IMA of 14 ± 6◦ to 10 ± 4◦ . There are too few cases to allow subgroup analysis. There is minimal shortening of the first metatarsal using this procedure because length lost by the arthroplasty procedure is regained using the spacer that increases the joint space. The single case available for histological evaluation (see Fig. 8) appears to indicate that the spacer is replaced by fibrous tissue adhering to the bone. One female patient who had constant pain not related to activity and stiffness (pre-operative AOFAS-HMI 23, and post-operative AOFAS-HMI 20) required an arthrodesis with bone graft owing to constant pain. After the operation her function did not improve and her pain score remained maximal. Histological analysis confirmed fibro-arthrosis in the joint without an inflammatory component (Fig. 8). In summary, 3 (10%) of the cases were associated with postoperative complications, 1 (3.13%) case of neuroma in scar resolved after one year of pain, 1 case (3%) had to be revised as described
E. Heller, D. Robinson / The Foot 21 (2011) 119–123
123
[15]. It is known that PDGF release from platelets encourages fibrocartilage repair of chondral lesions. The spongy physical properties of the gelatin sponge enhance clot formation and provide structural support for the forming clot [9]. We were able to achieve 100% follow-up, and there was observed a two-fold AOFAS-HMI score improvement. Our postoperative AOFAS-HMI scores compare well with prior publications that focus on first MTPJ total joint replacement with similar follow-up periods and patient numbers using the AOFAS-HMI scale [16–18]. Most points were lost because of pain and limitations of the range of joint movement. It should be explained to the patients that full range of motion or complete pain relief are not a realistic prospect. Financial disclosure
Fig. 8. Histological evaluation of a retrieved Gelfoam® arthroplasty, reveals fibrosis, with some giant cells but no inflammatory cells in close proximity to living trabecular bone (original magnification 60×, H&E stain).
above, and in one case limited active toe extension was suspected to be due to EHL tendon entrapment, but it was not revised. 3. Discussion Our study focused on functional outcomes and complications associated with GelfoamTM arthroplasty. Gelfoam is a medical device intended for application to bleeding surfaces as a hemostatic. It is a water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified pork skin gelatin. When it is saturated with sterile sodium chloride solution, it is indicated in surgical procedures, including those involving cancellous bone bleeding, as a hemostatic device. It is our experience that in order to achieve collateral tightness while restricting the amount of material packed into the joint, it is better not to immerse the product in water, but to insert it in dry. The product gets rapidly soaked in blood, even when a tourniquet is used. Gelfoam should be used sparingly according to the manufacturers instructions [9]. This is partly due to the unusual risk of infection, and this procedure should not be used in the presence of known infection. The suitability of Gelfoam for this procedure is dependent on two properties that have previously been the cause of complications related to its use. One property is its tendency to swell. This has previously caused neural damage when used after laminectomy in close proximity to the neural elements [9]. Gelfoam should not be packed into bony cavities as it might cause pressure-necrosis. We have not observed such a complication in our series. This is perhaps due to the lack of tight capsular suturing employed in this series. The upside of this swelling tendency is the ability of the implant to maintain joint spacing. The other property of Gelfoam is its tendency to encourage fibrosis. It has been reported to cause tendon fibrosis following tendon suturing. The mechanism of action of surface-mediated hemostatic devices is supportive and mechanical. Surface acting devices, when applied directly to bleeding surfaces, arrest bleeding by forming a clot. Steadman et al. have shown that such “super” clot encourages fibrocartilage repair of the joint [14]. Jenkins and Senz have suggested that the clotting effect of Gelfoam may be due to thromboplastin release from platelets
The authors have received no benefits or grants related to this study. Conflict of interest None reported. References [1] Wagenmann B, Schuh R, Trnka HJ. Functional outcome of cheilectomy for the treatment of hallux rigidus. Z Orthop Unfall 2010. [2] Hahn MP, Gerhardt N, Thordarson DB. Medial capsular interpositional arthroplasty for severe hallux rigidus. Foot Ankle Int 2009;30:494–9. [3] Malerba F, Milani R, Sartorelli E, Haddo O. Distal oblique first metatarsal osteotomy in grade 3 hallux rigidus: a long-term followup. Foot Ankle Int 2008;29:677–82. [4] Smith RW, Katchis SD, Ayson LC. Outcomes in hallux rigidus patients treated nonoperatively: a long-term follow-up study. Foot Ankle Int 2000;21: 906–13. [5] Brage ME, Ball ST. Surgical options for salvage of end-stage hallux rigidus. Foot Ankle Clin 2002;7:49–73. [6] Saxena A. The Valenti procedure for hallux limitus/rigidus. J Foot Ankle Surg 1995;34:485–8. [7] Saxena A. Valenti arthroplasty. J Foot Ankle Surg 1996;35:86–7. [8] DeFrino PF, Brodsky JW, Pollo FE, Crenshaw SJ, Beischer AD. First metatarsophalangeal arthrodesis: a clinical, pedobarographic and gait analysis study. Foot Ankle Int 2002;23:496–502. [9] Gelfoam® , absorbable gelatin powder (absorbable gelatin powder from absorbable gelatin sponge, USP); 2010. http://www.pfizer.com/files/products/ uspi gelfoam powder.pdf. [10] Kitaoka HB, Alexander IJ, Adelaar RS, Nunley JA, Myerson MS, Sanders M. Clinical rating systems for the ankle–hindfoot, midfoot, hallux, and lesser toes. Foot Ankle Int 1994;15:349–53. [11] DARCO TASTM -Toe Alignment Splint; 2010. http://www.darcointernational. com/tas. OrthoWedgeTM ; [12] DARCO 2010. http://www.darcointernational.com/ orthowedge. [13] Coughlin MJ, Shurnas PS. Hallux rigidus. Grading and long-term results of operative treatment. J Bone Joint Surg Am 2003;85-A:2072–88. [14] Steadman JR, Rodkey WG, Rodrigo JJ. Microfracture: surgical technique and rehabilitation to treat chondral defects. Clin Orthop Relat Res 2001:S362–9. [15] Jenkin HP, Senz E. Control of arterial hemorrhage by a gelatin sponge cuff and chromic surgical gut sheath; a new experimental method. Arch Surg 1947;55:637–49. [16] Arbuthnot JE, Cheung G, Balain B, Denehey T, Higgins G, Trevett MC. Replacement arthroplasty of the first metatarsophalangeal joint using a ceramic-coated endoprosthesis for the treatment of hallux rigidus. J Foot Ankle Surg 2008;47:500–4. [17] Fuhrmann RA, Wagner A, Anders JO. First metatarsophalangeal joint replacement: the method of choice for end-stage hallux rigidus? Foot Ankle Clin 2003;8:711–21, vi. [18] Pulavarti RS, McVie JL, Tulloch CJ. First metatarsophalangeal joint replacement using the bio-action great toe implant: intermediate results. Foot Ankle Int 2005;26:1033–7.