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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