We do get many emails about ankle pain. Some people write that they are on a waiting list for an ankle fusion, sometimes one, sometimes both ankles, and while they are waiting, they want to know if stem cell therapy can be an option. Others write that the are bone on bone and have lost all the cartilage in their ankle, can we help?
Treatment options for advanced ankle osteoarthritis
A study published in March 2019 (1) discusses the problem orthopedists and surgeons have in presenting treatment options to their patients with advanced ankle osteoarthritis. As many doctors and patients are aware, ankle osteoarthritis treatment protocols have no real guideline recommendations of its own. Researchers say most doctors treat an ankle problem as they would treat a knee or hip and follow hip or knee treatment protocols when treating the ankle. Is this really such a bad thing?
It is when you consider that these are the same guidelines of conservative care protocols that ultimately lead to patient pain management programs until such time that the knee or hip can be ultimately replaced. The difference in treating an ankle like a hip or an ankle like a knee is that doctors feel that if conservative care options do not work for knee or hip osteoarthritis, there is a reasonably reliable surgical option in total joint replacement. The same reasonably reliable surgical option, researchers suggests, may not be available for ankle replacement.
The risks and rewards of ankle arthrodesis or ankle fusion and total ankle replacement.
Recent research in the British medical bulletin (2) discuss the risks and rewards of ankle arthrodesis or ankle fusion and total ankle replacement.
- Total ankle replacement while an accepted treatment for end-stage ankle osteoarthritis has a higher need for revision surgery than ankle fusion.
- While surgical outcome results are gradually improving, Total ankle replacement cannot yet be recommended for the routine management of ankle osteoarthritis.
A September 2022 study (17) continued to analyze the differences in the rates of complications and reoperations at both 30 days and one year within a matched sample of total ankle replacement and ankle arthrodesis (fusion) patients from a large database population. After matching both total ankle replacement and ankle fusion groups for confounding variables, such as diabetes, smoking, obesity, and comorbidities scores, the differences in the rates of complications at 30 days and one year found the rate of surgical site infection and wound dehiscence (open wound) were higher at 30 days in the fusion group. About 63.45% of complications happened after 30 days. The fusion group showed a higher rate of surgical site infection, wound dehiscence, mechanical complications, and pneumonia at one year. The rate of reoperation was also higher in the fusion group at one year.
Younger than 65 and obese. Two main factors for total ankle replacement
A February 2021 study (3) found that increased risk for total ankle replacement failure was seen more in patients under the age of 65, as opposed to older patients who did not have increased risk, and in patients who were obese as opposed to normal weight patients.
- Failure of total ankle replacement was defined as a patient having to then undergo revision total ankle replacement or ankle fusion procedures.
The more ankle replacements, the more failures
In the medical journal Foot & ankle specialist, Duke university doctors wrote as the number of total ankle replacements performed has risen, so has the need for a specialty medicine to perform secondary or revision surgery to fix the primary ankle replacement failure.(4)
These are the people studied in this report:
- 193 patients
- The majority of the revision surgeries had:
- hardware component loosening, frequently of the talar component (38%).
- In the cases that were revised to an ankle fusion, 81% fused after their first fusion procedure.
- The overall complication rate was 18.2%, whereas the overall nonunion rate was 10.6%.
Surgery can cause pain and complication in healthy ankle tissue
Research in the Journal of Foot and Ankle Surgery (5) examined why a patient will still have chronic ankle pain following ankle replacement:
The researchers suggested:
- “Total ankle replacement studies have focused on reporting complications that are directly observed clinically or radiographically, including wound problems, technical errors, implant loosening, subsidence, infection, bone fractures, and heterotopic ossification. However, patients can still experience unresolved pain even when these problems have been ruled out.”
- The researchers then initiated a study to more clearly define the relative risk of injury to the anatomic structures in the posterior (rear) ankle during total ankle replacement. They found:
- High rates of posterior structural injury from the surgery was found.
- Pins inserted during the surgery represented a high risk of damage to the tibial nerve posteromedial tendinous structures, in particular, the flexor digitorum longus tendon.
- The proximal lateral pins were highly likely to encounter the Achilles tendon and the sural nerve.
- The researchers concluded: “Our results support our hypothesis that the tibial neurovascular structures are at the greatest risk when preparing for and completing the bony resection, particularly with the medial and proximal cuts. Posterior ankle soft tissue structure injuries can occur during implantation but currently with unknown frequency and undetermined significance. Further study of posterior structural injuries could result in a more informed approach to post-total ankle replacement complications and management.”
Is an ankle fusion better than an ankle replacement? Is the ankle replacement better?
This is another question I am often asked and again I reply that if you have a good range of motion, even through pain, you would likely be a good candidate for stem cell therapy.
But what if your mind is set on surgery. Which is better? Here is an opinion from the Department of Orthopaedic Surgery, Tulane University School of Medicine published in the research Janaury 2021. (6)
“There (is little) data comparing complications between ankle arthrodesis (fusion) versus total ankle arthroplasty (replacement) for operative management of primary osteoarthritis (osteoarthritis). This study aimed to compare outcomes following ankle arthrodesis (fusion) versus total ankle arthroplasty (replacement) for primary ankle osteoarthritis using a large patient database.
Results: A total of 1136 (67%) patients received ankle arthrodesis (fusion) and 584 (33%) patients underwent total ankle arthroplasty (replacement). Patients that received ankle arthrodesis (fusion) exhibited significantly higher rates of at least one common joint complication at 90 days, 1 year, and 2 years postoperatively. This included higher rates of adjacent fusion or osteotomy procedures, periprosthetic fractures, and hardware removal at each postoperative follow-up. Rates of prosthetic joint infection were comparable at 2 years postoperatively.
Conclusion: The ankle arthrodesis (fusion) cohort exhibited higher rates of postoperative joint complications in the short and medium-term, namely, subsequent fusions or osteotomies, periprosthetic fractures, and hardware removal.”
A May 2021 study (7) suggested total ankle replacement showed significantly greater post-operative range of motion than ankle fusion but no other differences in other patient-reported outcome scores. Patients undergoing total ankle replacement showed higher post-operative SF-36 (36 question health status survey). The total complication rate was similar between the two procedures including the incidence of re-operations.
Conclusion: While total ankle replacement and ankle fusion showed no differences in most post-operative functional outcomes, patients undergoing total ankle replacement show better health-related quality of life than ankle fusion. The study found no evidence to suggest that total ankle replacement carries a higher risk of complications and re-operations compared to ankle fusion.
Continued pain after ankle replacement
There are many people who have had very successful ankle replacement surgeries.
People who reach out to our office will share a similar story. They had an ankle replacement and they still have pain. Their surgeon has recommended moving over to a fusion surgery. To many of these people the point of getting the ankle replacement was to reduce their pain and allow them mobility to continue with “normal activities.” Fusion surgery will severely restrict those activities and movements in many.
One reason that a patient will continue to have pain after ankle replacement is joint loosening. The ankle replacement is no longer stable and the patient suffers from the same type of ankle instability that they had suffered from before the surgery. The difference here is that the surviving ligaments, tendons and other soft tissue are now being stretched as the ankle becomes wobbly. The other reason for pain after ankle replacement is the problem of nerve damage caused by the surgery. Let’s look at what the surgeons have to say and then we can discuss the possible treatment options that may allow some people to avoid a revision ankle replacement or an ankle fusion.
The outcomes of revision surgery for a failed ankle arthroplasty
A July 2022 study (19) measured the outcomes of revision surgery for a failed ankle arthroplasty. The researchers wrote: “Revision rates for ankle arthroplasties are higher than hip or knee arthroplasties. When a total ankle arthroplasty fails, it can either undergo revision to another ankle replacement, revision of the total ankle arthroplasty to ankle arthrodesis (fusion), or amputation.” Currently, they also note, there is not much information in the medical literature on the outcomes of these revisions.
The researchers then assessed the outcomes of revision total ankle arthroplasty with respect to surgery type, functional outcomes, and reoperations. They examined six previously published papers on all-cause reoperations of revision ankle arthroplasties, and 14 papers analyzing failures of conversion of a total ankle arthroplasty to fusion.
- It was found that 26.9% of revision ankle arthroplasties required further surgical intervention and 13.0% of conversion to fusions; 14.4% of revision ankle arthroplasties failed and 8% of conversion to fusions failed.
The researchers concluded: “Conclusion: Revision of primary total ankle arthroplasty can be an effective procedure with improved functional outcomes, but has considerable risks of failure and reoperation, especially in those with periprosthetic joint infection. In those who undergo conversion of total ankle arthroplasty to fusion, there are high rates of nonunion.”
Salvaging the ankle after a failed total ankle arthroplasty
A March 2022 paper (20) discussed salvaging the ankle after a failed total ankle arthroplasty: “The number of patients with osteoarthritis of the ankle, which are treated by arthroplasty, has continuously increased in recent years. The survival time of these implants is far below the results following hip and knee arthroplasty. In some cases a failure rate of approximately 1% per year or a survival rate of 70% after 10 years has been reported. The most frequent reasons for revision of an ankle prosthesis are aseptic loosening, technical implantation errors and persisting pain. For the revision of an ankle prosthesis there are basically two treatment options. For a long time, ankle arthrodesis (fusion) was considered the gold standard after a failed prosthesis. In recent years, there has been an increasing trend towards re-implantation of an ankle prosthesis (redoing the ankle replacement), as this preserves the functionality and mobility of the ankle joint as far as possible.”
A total of 32 implants failed (16%), requiring revision surgery.
A January 2019 study (21) assessed the survivorship and long-term outcome of a consecutive series of 200 Scandinavian Total Ankle Replacement (STAR) implants. The Scandinavian Total Ankle Replacement (STAR) implant is currently in its fourth generation and is the only 3-piece mobile bearing ankle prosthesis available in the United States.(22)
This was a long-term study as the assessment was made on implants done between November 1993 and February 2000.
A total of 84 patients (87 ankles) were alive by the end of this 2019 study. Of the surviving 84 patients (87 ankles; rheumatoid arthritis diagnosis in 40 patients and osteoarthritis in 47 patients), 45 were women and 39 were men, with a mean age of 54 years (18 to 72 years) at the time of surgery.
- A total of 32 implants failed (16%), requiring revision surgery.
- The mean time to revision was 80 months (2 to 257).
- The implant survival at 15.8 years, using revision as an endpoint, was 76.16%
- We found a steady but low decrease in survival over the study period.
A March 2021 paper (23) writes: “Given the increasing usage of total ankle arthroplasty, a better understanding of the reasons leading to implant revision and the factors that might influence those indications is necessary to identify at-risk patients.
Using a single-design three-component ankle prosthesis, the researchers asked:
- (1) What is the cumulative incidence of implant revision at 5 and 10 years?
- (2) What are the indications for implant revision in our population?
- (3) What factors are associated with an increased likelihood of implant revision during the time frame in question?
The answers: “The cumulative incidence of implant revision at the mean (range) follow-up time of 8.8years average was was 9.8%. Five and 10 years after total ankle arthroplasty, cumulative incidence was 4.8% and 12.1%, respectively. The most common reason for revision was instability (34% [41 of 121]), followed by aseptic loosening of one or more metallic components (28% [34 of 121]), pain without another cause (12% [14 of 121]), cyst formation (10% [12 of 121]), deep infection (9% [11 of 121]), and technical error (7% [9 of 121]). Ankles with a major hindfoot deformity before total ankle arthroplasty were more likely to undergo revision than ankles with a minor deformity or neutral alignment. A preoperative hindfoot valgus deformity increased revision probability compared with a varus deformity.
Conclusion: “Instability was a more common reason for implant revision after total ankle arthroplasty with this three-component design than previously reported. All causes inducing either a varus or valgus hindfoot deformity must be meticulously addressed during total ankle arthroplasty to prevent revision of this implant.”
The research on bone marrow aspirate concentrate for ankle osteoarthritis
Many people call our office and they want to know about stem cell therapy. Many times they call our office looking for advice on getting stem cell therapy during an ankle procedure. Specifically, if this will make the surgical outcome better. There always has to be realistic expectation of what stem cells can do for advanced ankle osteoarthritis, even when stem cells are administered during a surgery.
An August 2021 study (8) evaluated the long-term follow-ups in patients undergoing a one-step procedure of debridement (removing dead tissue and debris) and bone marrow aspirate concentrate seeded in situ (at the site of the degenerative disease in the ankle) for the treatment of osteochondral lesions of the talus in ankles affected by osteoarthritis, documenting the duration of the clinical benefit and its efficacy in postponing end-stage procedures.
- Results: Almost two out of the three patients in the study were satisfied with results. Failure rate was 33.3%.
- Older patients and those with more complex cases requiring previous or combined surgeries had lower outcomes, as well as those affected by grade 3 osteoarthritis, who experienced a high failure rate of 71.4%.
A February 2022 study (18) evaluated a single-stage treatment of osteochondral defects of the ankle with bone marrow concentrate (BMC) in 94 patients. The “results strongly indicate that this bone marrow concentrate (BMC) treatment is safe for, and well tolerated by, patients with osteochondral defects of the ankle as both primary treatment and those who have failed primary treatment. This technique provides a safe, efficacious alternative to currently employed cartilage repair techniques, with favorable outcomes and a low complication rate at 36 months.
December 2016 research in the Journal of experimental orthopedics from doctors at the Steadman Philippon Research Institute (9) reviewed the research in the treatment of ankle osteoarthritis with bone marrow derived stem cells.
- The goal of this study was to review outcomes of bone marrow aspirate concentrate (bone marrow-derived stem cells) for the treatment of chondral (cartilage) defects and osteoarthritis of the talus of the ankle.
The researchers noted that there is not much research (at the time of this paper’s writing). . . Nonetheless, the evidence available showed varying degrees of beneficial results of bone marrow derived stem cell therapy for the treatment of ankle cartilage defects.
- The researchers hypothesized that bone marrow aspirate concentrate may be useful in regeneration of tissue, enhancing the quality of cartilage repair. As a result, BMAC promotes a potentially healthy environment for hyaline cartilage growth and repair.
- A 2009 study published in Clinical Orthopaedics and Related Research, reported that 94 % of patients returned to low impact sports activity at an average 4.4 months after bone marrow aspirate transplantation and 77 % of patients returned to high impact sports activity at an average 11.3 months. (10)
- The same researchers in 2013 reported that 73 % of the 36 patients playing sports before surgery were able to return to sports. They also reported that 22 % of these 36 patients were able to return to sport, but at a lower level than before surgery. (11)
- A 2011 study reported that 95 % of patients who had undergone Autologous Osteochondral Transplantation and Bone Marrow Aspirate Concentrate returned to their pre-symptom level of sporting activity at an average 13 weeks.(12)
A 2016 report in the Journal of experimental orthopaedics (13) examined ways to save the ankle from fusion and replacement. In this study, Italian researchers discussed joint saving procedures such as:
- Surgical procedures such as Arthroscopic debridement, arthrodiastasis, and osteotomy are the current joint sparing procedures, but, in the available studies, controversial results were achieved
- Better results for patients they speculated could be achieved with Mesenchymal stem cells (MSCs). They write that stem cells may be a good solution to prevent or reverse ankle degeneration, due to their immunomodulatory features (able to control the catabolic joint environment) and their regenerative osteochondral capabilities (able to treat the chondral defects).
In research from Korea, doctors found that after ankle surgery, such as osteotomy, ankle bones treated with bone marrow stem cell injections repaired significantly better than those not treated (14) My question is always, why not try it before the surgery?
A heavily cited and received 2015 study showed that stem cell treatments were able to regrow cartilage in ankles significant enough to improve function and pain levels in selected patients. Walking distances were shown to dramatically improve in the patient group.(15)
In a post-surgical study from December 2018, (16) researchers found the injection of bone marrow mesenchymal stem cells could improve the repair process of the osteonecrosis.
Surgical treatment of end-stage posttraumatic upper ankle arthrosis is challenging
A March 2022 paper (6) compares ankle replacement top ankle fusion: “Surgical treatment of end-stage posttraumatic upper ankle arthrosis is challenging. Highly variable revision rates have been reported with total ankle arthroplasty of the upper ankle joint (talocrural joint or tibiotalar joint, where the ankle meet the lower leg). This retrospective study compared revision rates with tibiotalar arthrodesis (fusion) and total ankle arthroplasty with a prosthesis to determine the superior treatment approach.
- Data for 148 patients (96 males and 52 females) with end-stage posttraumatic upper ankle arthrosis-including 88 treated with tibiotalar arthrodesis (fusion) and 60 with total ankle arthroplasty with a mean follow-up of 59 months-were analyzed.
Results: The overall revision rate was 28%; the rate was higher with total ankle arthroplasty (42%) than with tibiotalar fusion (18%). The total ankle arthroplasty group showed an increase in revisions from 12- to 24-month postsurgery. The most common cause of revision in the total ankle arthroplasty group was cysts (20%), and the most frequent reason for revision was nonunion (8%). Conclusion: “total ankle arthroplasty is associated with a high rate of revisions, especially from the 2nd year postsurgery. Therefore, tibiotalar fusion is the treatment of choice for end-stage posttraumatic upper ankle arthrosis.”
Can we help with your ankle pain?
Pain after an ankle replacement failure can be challenging to treat. In selected patients, pain can be alleviated with Platelet Rich Plasma and bone marrow aspirate stem cell injections. Injections are give into the surrounding and surviving ligaments and tendons. The soft tissue that hold the ankle together.
PRP treatments involve collecting a small amount of your blood and spinning it in a centrifuge to separate the platelets from the red cells. The collected platelets are then injected back into the injured area to stimulate healing and regeneration.
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