Bipolar Fresh Osteochondral Allografting of the Tibiotalar Joint

Bugbee, William D. MD; Khanna, Gaurav MD; Cavallo, Marco MD; McCauley, Julie C. MPHc; Görtz, Simon MD; Brage, Michael E. MD

Journal of Bone & Joint Surgery - American Volume:
doi: 10.2106/JBJS.L.00165
Scientific Articles
Abstract

Background: Tibiotalar arthritis in the young, active patient is a debilitating condition with limited treatment options. Bipolar tibiotalar fresh osteochondral allograft transplantation was conceived as a possible alternative to arthrodesis and arthroplasty. We reported our experience with bipolar ankle osteochondral allografts for the treatment of tibiotalar joint arthritis.

Methods: Between 1999 and 2008, we performed bipolar ankle allografts in eighty-eight ankles (eighty-four patients). Eighty-six ankles (eighty-two patients) had a minimum follow-up duration of two years. The mean patient age was forty-four years and 52% of the patients were male. Evaluation included frequency and type of reoperations, the Olerud-Molander Ankle Score, pain, function, and patient satisfaction. Radiographs were evaluated for graft healing, joint space narrowing, and graft collapse.

Results: The mean duration of follow-up was 5.3 years (range, two to eleven years). Thirty-six (42%) of the eighty-six ankles that had undergone allograft had further surgery since implantation. Of the eighty-six ankles, twenty-five ankles (29%) had undergone graft-related reoperations and were considered clinical failures (ten underwent revision allografts, seven underwent arthrodeses, six underwent conversions to total ankle arthroplasty, and two underwent below-the-knee amputations) and eleven ankles (13%) had had reoperations that were not necessarily related to the graft (e.g., implant removal, debridement, synovectomy, or distraction). Survivorship of the osteochondral allograft was 76% at five years and 44% at ten years. The mean Olerud-Molander Ankle Score was 61 points at the time of the latest follow-up. The majority of patients reported satisfaction (92%) with osteochondral allograft transplantation and less pain (85%) and improved function (83%) after the procedure.

Conclusions: Transplantation of a fresh bipolar ankle osteochondral allograft for the treatment of tibiotalar arthritis resulted in acceptable outcomes in this difficult population, with most patients having improved objective and subjective outcome measures. Subjective satisfaction was high in spite of the 29% clinical failure rate. Osteochondral allograft failure did not limit further surgical options. We concluded that transplantation of a bipolar ankle allograft is a useful alternative in carefully selected patients with advanced tibiotalar arthritis.

Level of Evidence: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Author Information

1Division of Orthopaedic Surgery, Scripps Clinic, 10666 North Torrey Pines Road, MS116, La Jolla, CA 92037. E-mail address for W.D. Bugbee: Bugbee.william@scrippshealth.org

2Department of Orthopaedic Surgery, Kaiser Permanente, 1011 Baldwin Park Boulevard, Baldwin Park, CA 91706

3II Clinic of Orthopaedics and Traumatology, Rizzoli Orthopaedic Institute, Via G.C. Pupilli 1, Bologna 40136, Italy

4Shiley Center for Orthopaedic Research & Education at Scripps Clinic, 11025 North Torrey Pines Road, Suite 200, MS 126, La Jolla, CA 92037

5Department of Orthopaedic Surgery, University of California San Diego, 350 Dickinson Street, San Diego, CA 92103

6Department of Orthopaedic Surgery and Sports Medicine, University of Washington, Harborview Medical Center, 3325 Ninth Avenue, Box 359799, Seattle, WA 98104

Article Outline

Treatment of advanced tibiotalar arthritis in young individuals is challenging. The currently accepted surgical treatment is arthrodesis, which, although associated with acceptable clinical outcomes, can lead to functional impairment, alterations in gait, and long-term sequelae to the surrounding joints1-7. Furthermore, the concept of arthrodesis is not often accepted by patients. Total ankle arthroplasty has traditionally been reserved for older, less active individuals. Even with rigorous selection criteria, the results of total ankle arthroplasty have been variable8-12. Newer generations of total ankle arthroplasty have been developed and may show potential for improved outcomes and lower complication rates. However, few outcome studies exist, and concern remains for extending total ankle arthroplasty to the younger, more active population. Recently, ankle distraction has been reported as an alternative treatment for ankle arthritis13,14. Although distraction shows promise as an alternative treatment modality, there is sufficient evidence regarding its clinical applications and efficacy15. Therefore, substantial clinical difficulty exists in the treatment of advanced ankle arthritis in the young adult and other treatment options are needed.

Fresh osteochondral allograft transplantation has been successfully utilized for the treatment of a wide spectrum of joint pathology, most commonly in the knee16-25. Osteochondral allografting in the ankle joint is less common. However, small fragment talar allografts used in the treatment of osteochondral lesions of the talus have demonstrated good success26-30. Few studies exist describing the use of osteochondral allograft for advanced tibiotalar arthritis. Elloesser31 was the first to describe bipolar ankle allografting in 1913. More recently, other authors have reported mixed results32-34.

In 1983, a fresh osteochondral allograft transplantation program was established at our institution to investigate the use of osteochondral allografts for a variety of chondral and osteochondral diseases. Although most of our clinical experience has involved the knee16,19,20, we have also investigated the use of osteochondral allografts for the treatment of osteochondral lesions of the ankle30,32,33. The purpose of this study was to evaluate the clinical and radiographic outcomes in a consecutive series of patients undergoing a bipolar osteochondral allograft transplantation for advanced tibiotalar arthritis. We hypothesized that the osteochondral allograft would be an acceptable alternative treatment for younger patients who either refused arthrodesis or were considered to be poor candidates for total ankle arthroplasty.

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Materials and Methods

Since 1983, our institutional review board-approved osteochondral allografting outcomes program has prospectively collected data on 174 osteochondral allograft procedures of the ankle in 138 patients. Of these, we identified eighty-four consecutive patients (eighty-eight ankles) who had undergone bipolar osteochondral allograft transplantation of the tibiotalar joint, had had surgery between 1999 and 2008, and had not had a previous arthroplasty or osteochondral allograft transplantation involving the tibial plafond and/or talus. Surgical procedures occurring after 1999 were selected to have a homogenous group of patients on whom a contemporary and standardized surgical technique was utilized. We obtained a minimum two-year follow-up on all but two patients (two ankles); therefore, the study population comprised the remaining eighty-two patients (eighty-six ankles). The indication for allograft surgery was symptomatic arthritis of the tibiotalar joint and failure of previous nonsurgical or surgical treatment. Relative contraindications included inflammatory arthritis, the presence of active infection, or deformity or instability of the ankle that was not correctable. High body mass index was not considered a contraindication. All patients had declined arthrodesis as an alternative treatment. The mean patient age at time of surgery was 44.3 years (range, eighteen to seventy-one years), and 52% of patients were male. Four patients underwent bilateral allografting (three simultaneous and one staged).

Once patients consented to undergo the allografting procedure, they were placed on a waiting list until donor tissue became available (typically one to six months). Fresh allograft tissue was obtained from healthy donors between the ages of sixteen and forty years who met the criteria of the American Association of Tissue Banks35. Donor tissue was recovered within twenty-four hours after donor death and then processed and maintained fresh at 4°C until the time of implantation. Preoperatively, the size of the donor tibia and talus was matched to the patient with use of radiographs and direct measurements of the allograft. All grafts passed a visual and tactile inspection of cartilage quality. Transplantation was performed between seven and twenty-eight days after graft recovery. No blood group matching or tissue typing was performed and no immunosuppressive therapy was employed.

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Surgery

Surgery was performed with the patient supine, with use of a direct anterior approach through the interval between the extensor hallucis longus and the tibialis anterior tendons under distraction by a temporary unipolar external fixator (Vision Unilateral Fixator; Biomet, Warsaw, Indiana) and with use of fluoroscopy, as previously described36. The tibiotalar joint was exposed anteriorly and was distracted 4 to 8 mm. With use of standard total ankle arthroplasty jigs (Agility; DePuy Orthopaedics, Warsaw, Indiana), the damaged articular portion of the talus and tibia was resected with use of an oscillating saw. The resection level of each bone was between 4 and 10 mm, depending on the amount of bone loss. As much native bone stock as possible was preserved to minimize the amount of transplanted allograft bone; cystic lesions extending beyond the depth of a resection level were cureted and grafted with autologous bone graft salvaged from the resected tibial plafond and talar dome (Fig. 1). The tibial allograft was fashioned from the distal tibial graft utilizing the arthroplasty cutting jig and the talar graft was prepared freehand. Each graft was between 8 and 12 mm in maximum thickness. Grafts underwent pulse lavage with normal saline prior to implantation to remove debris and marrow elements (Fig. 2). The position of the grafts and the proper restoration of tibiotalar anatomy were then confirmed fluoroscopically before removing the external fixator and fixing the graft with countersunk 3.0-mm metallic cannulated compression screws (Synthes, West Chester, Pennsylvania).

Postoperative care included protection in a non-weight-bearing short leg splint until suture removal at two weeks, followed by transition to a controlled ankle motion (CAM) walker to permit early ankle motion exercises. Patients were strictly non-weight-bearing for six weeks and then progressed to partial weight-bearing (25% to 50% of body weight) in the CAM walker, with functional rehabilitation for a period of at least six weeks. A gradual return to full weight-bearing was permitted once graft incorporation was confirmed radiographically, usually at twelve weeks.

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Outcomes

Patient demographics (age, sex, diagnosis), preoperative Olerud-Molander Ankle Scores, and details regarding the allograft were extracted from the outcomes database. The Olerud-Molander Ankle Score was developed to assess symptoms following ankle fractures37, and has been validated against subjective recovery as measured on a visual analog scale, ankle motion, the presence of osteoarthritis, and the presence of dislocations on radiographs38. Floor or ceiling effects have not been reported39. The Olerud-Molander Ankle Score is self-administered with scores ranging from 0 (totally impaired) to 100 points (completely unimpaired). Scores were categorized as excellent (91 to 100 points), good (61 to 90 points), fair (31 to 60 points), and poor (0 to 30 points). Patients returned for regular postoperative clinical examinations at six weeks, twelve weeks, six months, and annually thereafter. The number and types of reoperations following the allograft surgery were assessed. Clinical failure was defined as the need for revision osteochondral allografts, conversion to a total ankle arthroplasty, arthrodesis, or amputation. Patients whose grafts were in situ at the time of follow-up were administered the Olerud-Molander Ankle Scores and a survey that assessed current pain, functional status, and overall satisfaction with the allograft surgery. Data from each patient’s most recent follow-up were used for analysis. Patients missing current follow-up data were contacted via telephone and/or mail to obtain the aforementioned information.

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Radiographs

Radiographs were obtained preoperatively and at each clinical follow-up visit when possible. The most recent follow-up radiographs were utilized for the analysis. Radiographs were evaluated for joint space narrowing compared with the immediate postoperative radiograph (no narrowing or 25%, 50%, 75%, or 100% narrowing), interface healing (visible or not visible), radiodensity (increased, equal, or decreased compared with the host bone), the presence of subchondral cysts, areas of sclerosis, or collapse of the allograft. Radiographic failure was defined as >50% joint space narrowing and/or graft collapse. Advanced imaging studies such as computerized tomography or magnetic resonance imaging were not performed routinely.

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Statistical Analysis

Means and frequencies were calculated to describe characteristics of the study population, details regarding the allograft, and data collected at the time of follow-up (clinical and radiographic failure, pain, function, and patient satisfaction with the osteochondral allograft procedure). Osteochondral allograft survivorship was calculated with use of the Kaplan-Meier method with clinical failure of the allograft as defined above as the end point. Preoperative and follow-up Olerud-Molander Ankle Scores were compared with use of the Wilcoxon signed rank test for non-parametric data, and frequencies were used to categorize the percentage of patients who scored excellent, good, fair, and poor. A p value of ≤0.05 was considered significant.

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Source of Funding

Partial funding for this study was provided by the Joint Restoration Foundation, a nonprofit cooperative of AlloSource and Community Tissue Services (Centennial, Colorado). This funding source had no role in the preparation of the manuscript.

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Results

All patients had a minimum follow-up duration of two years. The mean duration of follow-up was 5.3 years (range, two to 11.1 years). Thirty-six (42%) of eighty-six ankles had further surgical procedures after the osteochondral allograft implantation. Of the eighty-six ankles, eleven (13%) had had reoperations that did not involve graft removal (e.g., implant removal, debridement, synovectomy, or distraction) and twenty-five (29%) were considered to be clinical failures. Of these twenty-five ankles, ten (40%) underwent a revision of the osteochondral allograft, seven (28%) underwent an arthrodesis, six (24%) underwent a conversion to a total ankle arthroplasty, and two (8%) underwent an amputation because of persistent pain. The mean time to failure (and standard deviation) was 3.7 ± 2.5 years (range, one to 9.3 years). Survivorship of the osteochondral allograft was 76% at five years and 44% at ten years (Fig. 3).

The mean Olerud-Molander Ankle Score improved from 27.7 points preoperatively to 61.1 points at the time of the latest follow-up (p < 0.001). Sixty-two percent of the ankles were categorized as having a good to excellent outcome (Table I). A substantial majority of the patients reported satisfaction (92%) with the osteochondral allograft transplantation and less pain (85%) and improved function (83%) after the procedure.

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Radiographs

Sixty-three postoperative radiographs (sixty-one patients) were available at a mean follow-up duration of 3.5 years (range, 0.4 to eleven years) (Figs. 4 and 5). Of the sixty-three ankles, twenty-nine (46%) were categorized as failures on radiographs, with >50% joint space narrowing compared with the initial postoperative radiographs. Graft collapse occurred in eleven (38%) of the twenty-nine ankles. Of the eleven ankles, the location of initial graft failure was the tibia in four ankles, the talus in two ankles, and both in five ankles. Eighteen of the radiographic failures were also considered clinical failures and underwent reoperation. Of the sixty-three ankles, the interface between the graft and the host bone was not visible (indicating graft incorporation) in forty-six ankles (73%), although radiodensity of the graft was equal to that of the host bone in thirty-seven ankles (59%) and increased in twenty-six ankles (41%), with no cases of decreased radiodensity of the graft compared with the recipient. Subchondral cysts affected twenty-two ankles (35%) and there were areas of sclerosis in thirteen ankles (21%).

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Discussion

The current study represents the largest series and longest follow-up of bipolar ankle allografts. The results presented here are incrementally better than those reported in previous studies, with 71% of the allografts remaining in situ at a mean duration of follow-up of 5.3 years. Those patients with intact grafts also showed improvement in ankle pain and function and high levels of satisfaction with the procedure. The improved outcome compared with previous ankle allograft studies may be due to better patient selection, but more likely it is due to improvements in surgical technique or perioperative patient management. Nonetheless, the overall rate of reoperation was very high (42%). The clinical failure rate of 29% is higher than those of most series of arthrodesis or arthroplasty. Importantly, a failed allograft was most commonly treated with another allograft (40%), but failure was also treated with ankle arthrodesis (28%) or arthroplasty (24%). The long-term consequence of reoperation for failed allograft surgery requires further study.

Previous investigators have described their experience with the use of fresh osteochondral allografts for the treatment of advanced ankle arthritis. Kim et al. reported the results of our initial series of seven patients with posttraumatic tibiotalar arthritis who underwent bipolar tibiotalar osteochondral shell allografting32. At a mean follow-up duration of 148 months, four of the seven patients reported good or excellent results. However, radiographs showed joint space narrowing, osteophyte formation, and sclerosis, even in those patients reporting an excellent outcome. Meehan et al. examined the results of eleven patients with posttraumatic arthritis, osteoarthritis, or osteochondral defects who underwent fresh osteochondral ankle allografting33. Six patients had successful operations, and five patients failed their initial allografting procedure (three underwent successful repeat allografting, one was revised to a total ankle arthroplasty, and one underwent no further surgical treatment). Tontz et al. reviewed the results of twelve allograft procedures with use of the Agility cutting jig40. Nine patients had a bipolar tibiotalar allograft, two patients had a unipolar talar allograft, and one patient had a unipolar tibial allograft. Overall, when followed for an average of twenty-one months, 42% required an additional surgical procedure, but only one allograft (a partial unipolar allograft of the lateral talar dome) had to be revised because of graft collapse. The remaining eleven allografts were still in situ at the time of the latest follow-up. Jeng et al. reported on their series of twenty-nine fresh osteochondral total ankle allograft transplants41. They found a high failure rate among their population with fourteen ankles needing revision, six of the remaining fifteen demonstrating radiographic failure, and only the remaining nine representing successful bipolar transplants. They compared their surgical technique to the technique reported in many of the published articles33,36,40 from the University of California, San Diego, noting an increase in the time from graft harvest to transplantation as well as the lack of use of an external fixator for distraction as part of the procedure in their cohort. A recent international study reported by Giannini et al. examined thirty-two patients who underwent bipolar fresh osteochondral allografting for severe posttraumatic ankle arthritis34. At two years of follow-up, six failures had occurred.

The outcome of bipolar ankle allograft transplantation reported in this study must be compared with the accepted treatment alternatives such as total ankle arthroplasty and arthrodesis, which have been widely investigated. Haddad and colleagues performed a meta-analysis on a total of 1262 patients undergoing either arthroplasty or arthrodesis8. Although they used different criteria from the present study for excellent, good, fair, and poor outcomes, they determined that 52% of the second-generation total ankle replacement patients had excellent results, 30% had good results, 4% had fair results, and 13% had poor results. The five-year implant survivorship rate was 78% and the ten-year implant survivorship rate was 77%. The revision rate for total ankle replacement was 7% and was primarily due to loosening and/or subsidence. In the fusion group, 35% had excellent results, 37% had good results, 14% had fair results, and 14% had poor results. Ankle fusion was associated with a 9% revision rate, primarily due to nonunion. One percent of the patients who had undergone total ankle arthroplasty required a below-the-knee amputation compared with 5% in the ankle arthrodesis group8. SooHoo et al. compared the reoperation rates following ankle arthrodesis and ankle replacement on the basis of observational, population-based data for a total of 4705 ankle fusions and 480 ankle replacements over a ten-year study period42. Patients who had undergone ankle replacement had an increased risk of device-related infection and of having a major revision procedure. The rates of major revision surgery after ankle replacement were 9% at one year and 23% at five years compared with 5% at one year and 11% at five years following ankle arthrodesis. Patients managed with ankle arthrodesis had a higher rate of subtalar fusion at five years postoperatively (2.8%) than did those managed with ankle replacement (0.7%). SooHoo et al. concluded that, compared with ankle fusion, ankle replacement is associated with a higher risk of complications but also has potential advantages in terms of a decreased risk of the patient subsequently requiring a subtalar joint arthrodesis. Spirt et al. reported on 306 primary total ankle arthroplasties that used the DePuy Agility Total Ankle System at a mean follow-up time of thirty-three months11. They reported a reoperation rate of 28% and a five-year implant survival rate of 80%. Younger age was the only significant predictor of reoperation and failure after total ankle arthroplasty. Coester et al. reported on twenty-two patients at a mean follow-up time of twenty-two years after successful ankle arthrodesis2. The majority of patients had substantial arthritic changes and pain in the ipsilateral foot.

These data suggest that the treatment of ankle arthritis remains a difficult clinical challenge regardless of the surgical intervention chosen, with relatively high reoperation and revision rates and important long-term consequences. Although new innovations in ankle arthroplasty may yield better results, few data exist in the management of younger patients. Arthrodesis has demonstrated a lower early complication rate but is still limited by a lack of patient acceptance, functional compromise, and potentially irreversible long-term sequelae, particularly degenerative changes in adjacent joints. Our hypothesis that ankle allograft transplantation addresses the issues associated with arthroplasty and arthrodesis and thus may be an acceptable alternative was not conclusively proven. Although patient satisfaction, pain relief, and functional outcome were generally good, the reoperation and revision rates were higher than those reported for arthrodesis or arthroplasty.

Certain limitations of the present study should be noted. In this consecutive series of patients, a patient selection bias did exist. Although we did not routinely exclude patients because of factors such as obesity, deformity, instability, bone loss, bone necrosis, or other clinical factors, all patients had refused arthrodesis or implant arthroplasty and were actively seeking alternatives. These patients were therefore very committed to the potential advantages of the allograft procedure, in spite of limited clinical outcome data to guide decision-making. This factor may help explain the relatively high patient satisfaction rate found in the study. Many patients who had failed allografts elected to have another allograft rather than proceed with arthrodesis or arthroplasty. Another limitation of the study was the incomplete radiographic follow-up. As our institution is a tertiary referral center, many patients were unable to return consistently for postoperative examination and radiographs. It is possible that some additional patients had a poor radiographic appearance of their allograft and were at risk of clinical failure, which would increase the overall failure rate reported in this study. Our finding that there was no consistent correlation between radiographic and clinical failure may suggest that the allografting procedure results in a partial denervation of the ankle joint.

Other potential challenges with the ankle allograft procedure included relative cost and logistics. Although we did not perform a cost-utility analysis, our institution estimated the total cost of the procedure to be similar to that of hip, knee, or ankle arthroplasty. From the perspective of the patient and surgeon, the logistics of the treatment could be challenging, with little or no ability to predict the availability of a fresh allograft and schedule surgery at a convenient time.

In conclusion, this study demonstrates that bipolar osteochondral allograft transplantation of the ankle is associated with good clinical outcomes and high satisfaction in the majority of patients and may be an alternative to arthrodesis or total ankle arthroplasty in younger individuals with disabling ankle arthritis. However, the allograft procedure is technically challenging, and it is associated with a high reoperation rate. As a result of this study, we are more restrictive in our use of this procedure for end-stage ankle arthritis. Further study of the indications, risks, benefits, and outcomes of this procedure is necessary; however, bipolar osteochondral allograft transplantation of the ankle represents a possible approach with use of the concept of biological ankle arthroplasty.

Investigation performed at the Scripps Clinic, La Jolla, California

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Disclosure: One or more of the authors received payments or services, either directly or indirectly (i.e., via his or her institution), from a third party in support of an aspect of this work. In addition, one or more of the authors, or his or her institution, has had a financial relationship, in the thirty-six months prior to submission of this work, with an entity in the biomedical arena that could be perceived to influence or have the potential to influence what is written in this work. No author has had any other relationships, or has engaged in any other activities, that could be perceived to influence or have the potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitted by authors are always provided with the online version of the article.

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