Prospective Randomized Trial Comparing Mobile-Bearing and Fixed-Bearing Total Ankle Replacement

2019 ◽  
Vol 40 (11) ◽  
pp. 1239-1248 ◽  
Author(s):  
James A. Nunley ◽  
Samuel B. Adams ◽  
Mark E. Easley ◽  
James K. DeOrio

Background: Outcomes of total ankle replacement for the treatment of end-stage ankle arthritis continue to improve. Debate continues whether a mobile-bearing total ankle replacement (MB-TAR) or a fixed-bearing total ankle replacement (FB-TAR) is superior, with successful outcomes reported long term for MB-TAR and at intermediate- to long-term follow-up for newer generation FB-TAR. Although comparisons between the 2 total ankle designs have been reported, to our knowledge, no investigation has compared the 2 designs with a high level of evidence. This prospective, randomized controlled trial conducted at a single institution compares patient satisfaction, functional outcomes, and radiographic results of the mobile-bearing STAR and the fixed-bearing Salto-Talaris in the treatment of end-stage ankle arthritis. Methods: Between November 2011 and November 2014, adult patients with end-stage ankle osteoarthritis failing nonoperative treatment were introduced to the study. With informed consent, 100 patients (31 male and 69 female, average age 65 years, range 35-85 years) were enrolled; a demographic comparison between the 2 cohorts was similar. Exclusion criteria included inflammatory arthropathy, neuropathy, weight exceeding 250 pounds, radiographic coronal plane deformity greater than 15 degrees, or extensive talar dome wear pattern (“flat-top talus”). Prospective patient-reported outcomes, physical examination, and standardized weightbearing ankle radiographs were obtained preoperatively, at 6 and 12 months postoperatively, and then at yearly intervals. Data collection included visual analog pain score, Short Form 36, Foot and Ankle Disability Index, Short Musculoskeletal Functional Assessment, and American Orthopaedic Foot & Ankle Society ankle-hindfoot score. Surgeries were performed by a nondesign team of orthopedic foot and ankle specialists with total ankle replacement expertise. Statistical analysis was performed by a qualified statistician. At average follow-up of 4.5 years (range, 2-6 years) complete clinical data and radiographs were available for 84 patients; 7 had incomplete data, 1 had died, 4 were withdrawn after enrolling but prior to surgery, and 4 were lost to follow-up. Results: In all outcome measures, the entire cohort demonstrated statistically significant improvements from preoperative evaluation to most recent follow-up with no statistically significant difference between the 2 groups. Radiographically, tibial lucency/cyst formation was 26.8% and 20.9% for MB-TAR and FB-TAR, respectively. Tibial settling/subsidence occurred in 7.3% of MB-TAR. Talar lucency/cyst formation occurred in 24.3% and 2.0% of MB-TAR and FB-TAR, respectively. Talar subsidence was observed in 21.9% and 2.0% of MB-TAR and FH-TAR, respectively. Reoperations were performed in 8 MB-TARs and 3 FH-TARs, with the majority of procedures being to relieve impingement or treat cysts and not to revise or remove metal implants. Conclusion: With a high level of evidence, our study found that patient-reported and clinical outcomes were favorable for both designs and that there was no significant difference in clinical improvement between the 2 implants. The incidence of lucency/cyst formation was similar for MB-TAR and FH-TAR for the tibial component, but the MB-TAR had greater talar lucency/cyst formation and tibial and talar subsidence. As has been suggested in previous studies, clinical outcomes do not necessarily correlate with radiographic findings. Reoperations were more common for MB-TAR and, in most cases, were to relieve impingement or treat cysts rather than revise or remove metal implants. Level of Evidence: Level I, prospective randomized study.

2018 ◽  
Vol 3 (3) ◽  
pp. 2473011418S0009
Author(s):  
James Nunley ◽  
Samuel Adams ◽  
James DeOrio ◽  
Mark Easley

Category: Ankle Arthritis Introduction/Purpose: Outcomes of total ankle replacement for the treatment of end-stage ankle arthritis continue to improve. Debate continues whether a mobile-bearing total ankle replacement (MB-TAR) or a fixed-bearing total ankle replacement (FB-TAR) is superior, with successful outcomes reported longterm for MB-TAR and at intermediate-to-longterm follow-up for newer generation FB-TAR. Although comparisons between the two total ankle designs have been reported, to our knowledge, no investigation has compared the two designs with a high level of evidence. This prospective, randomized controlled trial conducted at a single institution compares patient satisfaction, functional outcomes and radiographic results of the mobile-bearing STAR and the fixed-bearing Salto-Talaris in the treatment of end-stage ankle arthritis. Methods: This investigation was approved by our institution’s IRB committee. Between November 2011 and November 2014, adult patients with end-stage ankle osteoarthritis failing nonoperative treatment were introduced to the study. With informed consent, 100 patients (31 male and 69 female, average age 65, range 35 to 85) were enrolled; demographic comparison between the two cohorts was similar. Exclusion criteria included inflammatory arthropathy, neuropathy, weight exceeding 250 pounds, radiographic coronal plane deformity greater than 15 degrees or extensive talar dome wear pattern (“flat top talus”). Prospective patient-reported outcomes, physical exam and standardized weightbearing ankle radiographs were obtained preoperatively, at 6 and 12 months postoperatively, and then at yearly intervals. Data collection included visual analog pain score (VAS), short form 36 (SF-36), foot and ankle disability index (FADI), short musculoskeletal functional assessment (SMFA) and AOFAS ankle-hindfoot score. Surgeries were performed by non-design team orthopaedic foot and ankle specialists with total ankle replacement expertise. Statistically analysis was performed by a qualified statistician. Results: At average follow-up of 4.5 years (range 2-6 years) complete clinical data and radiographs were available for 84 patients; 7 had incomplete data, one had died, 4 were withdrawn after enrolling but prior to surgery and 4 were lost to follow-up. In all outcome measures, the entire cohort demonstrated statistically significant improvements from preoperative evaluation to most recent follow-up. There was no statistically significant difference in improvement in clinical outcomes between the two groups. Radiographically, tibial lucency/cyst formation was 26.8% and 20.9% for MB-TAR and FB-TAR, respectively. Tibial settling/subsidence occurred in 7.3% of MB-TAR. Talar lucency/cyst formation occurred in 24.3% and 2.0% of MB-TAR and FB-TAR, respectively. Talar subsidence was observed in 21.9% and 2.0% of MB-TAR and FB-TAR, respectively. Re-operations were performed in 8 MB-TAR and 3 FB-TAR, with the majority of procedures being to relieve impingement or treat cysts and not to revise or remove metal implants. Conclusion: For the first time, with a high level of evidence, our study confirms that patient reported and clinical outcomes are favorable for both designs and that there is no significant difference in clinical improvement between the two implants. The incidence of lucency/cyst formation was similar for MB-TAR and FB-TAR for the tibial component, but the MB-TAR had greater talar lucency/cyst formation and tibial and talar subsidence. As has been suggested in previous studies, clinical outcomes do not correlate with radiographic findings. Re-operations were more common for MB-TAR and in the majority of cases were to relieve impingement or treat cysts rather than revise or remove metal implants.


2021 ◽  
pp. 107110072110538
Author(s):  
Georg Hauer ◽  
Reinhard Hofer ◽  
Markus Kessler ◽  
Jan Lewis ◽  
Lukas Leitner ◽  
...  

Background: The aim of this study was to assess the outcome of total ankle replacement (TAR) regarding revision rates by comparing clinical studies of the last decade to data displayed in arthroplasty registers. The secondary aim was to evaluate whether dependent clinical studies show a superior outcome to independent publications. Additionally, revision rates of mobile bearing implants (MB-TARs) were compared to those of fixed bearing implants (FB-TARs). Methods: Clinical studies on TARs between 2010 and 2020 were systematically reviewed, with the endpoint being a revision for any reason. The parameter “revision rate per 100 observed component years (CYs)” was calculated for each publication. The pooled revision rate for clinical studies was compared to the data reported in arthroplasty registers. In a second step, revision rates were subdivided and analyzed for independent and dependent publications and for FB-TARs and MB-TARs. Results: A total of 43 publications met the inclusion criteria comprising 5806 TARs. A revision rate of 1.8 per 100 observed CYs was calculated, corresponding to a 7-year revision rate of 12.6%. The 3 arthroplasty registers included showed revision rates ranging from 8.2% to 12.3% after 7 years. No significant difference between dependent and independent publications nor between FB-TARs and MB-TARs was detected. Conclusion: Revision rates of clinical studies and arthroplasty registers are comparable. Surgeons can compare their own revision rates with those from this study. Dependent studies do not seem to be biased, and no superiority for one bearing type can be described. Level of Evidence: Level III, systematic review of level III studies


2019 ◽  
Vol 4 (2) ◽  
pp. 2473011419S0000
Author(s):  
James Lachman ◽  
Michel Taylor ◽  
Elizabeth Cody ◽  
Daniel Scott ◽  
James A. Nunley ◽  
...  

Category: Ankle Arthritis Introduction/Purpose: The Scandinavian Total Ankle Replacement(STAR) system and Salto Talaris(ST) total ankle system are two of the more commonly studied total ankle implants. As the STAR is one of the oldest total ankle arthroplasty (TAA) implants still in use today, most studies focus on longevity and survivorship. Reported rates of cyst formation for these two prosthesis in most series vary from 11-22% but no large study has focused on surgical management of these cysts or included patient reported outcomes after surgery. In this series, we aimed to investigate rates of cyst formation between mobile(MB) and fixed-bearing(FB) TAA and examine clinical and patient reported outcomes of bone grafting or cementing of large cysts surrounding the STAR and ST implants. Methods: A prospectively collected database at a high volume total ankle replacement center was retrospectively reviewed to identify patients who underwent TAA with either the STAR or the ST total ankle system between 2007 and 2015. Cysts were identified and measured on standard weight bearing radiographs and confirmed on computed tomography(CT) when available. Visual analog scale (VAS) score, Short Form-36 (SF-36) physical and mental component scores, Short Musculoskeletal Function Assessment(SMFA), and AOFAS hindfoot scores were collected from all patients preoperatively and then at 6 months, 1 year and annually postoperatively. Patients with a minimum 2 years follow-up who underwent revision TAA secondary to catastrophic bone cysts or who were managed with either curettage and bone grafting or curettage and cementing of bone cysts surrounding the TAA prosthesis were included in the patient reported outcomes (PRO) analysis Results: Excluding 53 patients for inadequate follow-up, 232 patients (29% female, 71% male; follow-up 6.7 years) who underwent STAR-TAA and 147 patients (26.6% female, 73.5% male; follow-up 7 years) who underwent ST-TAA were identified. Cysts <20 mm diameter occurred more often in the MB TAAs, and more often in the tibia than talus (table). Cysts >10 mm were identified in 95/232 (41%) STAR and 24/147 (16%) ST ankles. In the STAR group, 24 patients underwent cyst bone grafting (13), cementing (6) or both (8) at a mean 4.8 years. In the ST group, 14 patients underwent cyst bone grafting (6), cementing (4), or both (4) at a mean of 2.7 years. PRO data improved significantly for both the STAR and ST group in all questionnaires (p<0.05 for all). Conclusion: Mobile-bearing total ankle arthroplasty in this cohort had a higher rate of cyst formation greater than 10 mm (95/232 patients, 41%) when compared to a fixed-bearing TAA (24/147, 16.3%). Only 24/95 (25%) of STAR patients and 14/24 (58%) of ST patients required surgical intervention for cyst management. Patient reported outcomes after cyst surgery improved significantly when compared to pre-cyst management surgery and did not differ between MB and FB cohorts (p=0.424). Successful surgical management of large cyst surrounding either mobile-bearing or fixed-bearing total ankle systems can be expected based on the results of this study. [Table: see text]


2021 ◽  
Vol 10 (11) ◽  
pp. 2258
Author(s):  
Massimiliano Mosca ◽  
Silvio Caravelli ◽  
Emanuele Vocale ◽  
Simone Massimi ◽  
Davide Censoni ◽  
...  

Recently, the progress in techniques and in projecting new prosthetic designs has allowed increasing indications for total ankle replacement (TAR) as treatment for ankle osteoarthritis. This retrospective work comprehended 39 subjects aged between 47 and 79 years old. The patients, observed for at least 12 months (mean follow up of 18.2 ± 4.1 months), have been evaluated according to clinical and radiological parameters, both pre- and post-operatively. The AOFAS and VAS score significantly improved, respectively, from 46.2 ± 4.8 to 93.9 ± 4.1 and from 7.1 ± 1.1 to 0.7 ± 0.5 (p value < 0.05). At the final evaluation, the mean plantarflexion passed from 12.2° ± 2.3° to 18.1° ± 2.4° (p value < 0.05) and dorsiflexion from a pre-operative mean value of 8.7° ± 4.1° to 21.7° ± 5.4° post-operatively (p value < 0.05). This study found that this new total ankle replacement design is a safe and effective procedure for patients effected by end-stage ankle osteoarthritis. Improvements have been demonstrated in terms of range of motion, radiographic parameters and patient-reported outcomes. However, further studies are needed to assess the long-term performance of these prostheses.


2020 ◽  
Vol 5 (4) ◽  
pp. 2473011420S0042
Author(s):  
Hatem Salem-Saqer ◽  
Martin Raglan ◽  
Sunil Dhar

Category: Ankle; Ankle Arthritis Introduction/Purpose: Total ankle arthroplasty (TAA) is increasingly used for treatment of end stage arthritis of the ankle; improvements continue to evolve in implant design and instrumentation. We present our experience of the Infinity Total Ankle Arthroplasty (Wright Medical), a fixed bearing 4th generation implant with improved instrumentation Methods: This is a retrospective review of prospectively collected data. From October 2016 to July 2019, we identified 92 (52M/40F) who had the infinity Total Ankle Replacement. This review is of 70 patients with a minimum of 1 year follow up (33M,37F). The mean age was 67.5 years (33-87); 32 right side and 38 left no bilaterals. The indication for surgery was end stage Osteoarthritis in 52, post traumatic arthritis 12, inflammatory arthritis 4, conversion of fusion to TAR 2. The preoperative deformity was graded according to the COFAS classification. All patients had follow up at 6 weeks, 3,6 and 12 months and then annually, with MOXFQ questionnaire and weight bearing radiographs. Results: TAA was performed with the use of fluoroscopy. 77% (54/70) had concomitant procedures as listed in Table.5% (4/70) had complications consisting of, 1 DVT, 1 intra operative medial malleolus fracture, 1 EHL tendon laceration and 1 wound break down. There were no deep or superficial infections. Improvement in clinical outcome and PROMS data was noted on follow up. The MOXFQ for Pain improved from 72 pre-op to 25 at 1year (p<0.001). The outcome for Walking improved from 83 pre-op to 30 at one year (p<0.001). Radiological alignment was maintained asymptomatic posterior heterotopic ossification was noted in 23(16%) patients, lucent lines under the tibial implant were noted in 4 ankles and 1 fibula erosion. 2 TAA (3%) needed to be revised due to malpositioning. Conclusion: Our results show significant improvement in patient outcomes, a short recovery time and marked improvement in mobility post operatively with a very low complication rate, we had no deep infection to date. Two implants were revised which we attribute to the learning curve at the start of practice. This implant is fluoroscopically navigated allowing precise implantation with dedicated instrumentation and we feel this attributed to the low complication rate and good results in our short-term study [Table: see text]


2019 ◽  
Vol 4 (4) ◽  
pp. 2473011419S0032
Author(s):  
Andrea Pujol Nicolas ◽  
Jayasree Ramas Ramaskandhan ◽  
Triin Nurm ◽  
Malik Siddique

Category: Ankle, Ankle Arthritis Introduction/Purpose: Total ankle replacement as a valid treatment for end stage ankle arthritis, is gaining popularity and every year there is an increasing number of procedures. With revision rates as high as 21% at 5 years and 43% at 10 years there is a need for understanding and reporting the outcome of revision ankle replacement. Our aim was to study the patient reported outcomes following revision TAR with a minimum of 2 year follow up. Methods: All patients that underwent a revision total ankle replacement between 2012 and 2016 were included in the study. All patients received a post-operative questionnaire comprising of MOX-FQ score, EQ-5D (UK) and Foot and Ankle outcomes scores (FAOS) and patients satisfaction questionnaire with a minimum of 2 years follow up. Results: 32 patients had a revision total ankle replacement between 2012 and 2016. 2 patients were deceased therefore 30 patients were included in the study. 5 patients declined participation for completing questionnaires. We received 21 (66%) completed questionnaires. The mean MOX-FQ average domain score for pain was 58.8, walking/standing 65.8 and social function was 48.2. The mean FAOS scores were 50.7 for pain, 50.6 for symptoms, 54.9 for ADL and 28.2 for quality of life. The mean overall health score today for EQ-5D was 67.8/100. 45% of patients were satisfied with the pain relief and return to sports and recreation obtained following the operation, 48% were satisfied with the improved in daily activities. 52% were overall satisfied with the results from surgery. Conclusion: Revision total ankle replacement gives overall satisfactory results demonstrated from patients reported outcomes at a minimum of 2 years following surgery.


2018 ◽  
Vol 3 (3) ◽  
pp. 2473011418S0013
Author(s):  
Kevin Wing ◽  
Jason Sutherland ◽  
Timothy Daniels ◽  
Peter Dryden ◽  
Murray Penner ◽  
...  

Category: Ankle Arthritis Introduction/Purpose: There is much interest in the surgical treatment of end-stage ankle arthritis. Our team has previously reported comparisons between ankle fusion and replacement outcomes for 321 ankles at 5.5 years from a prospective cohort. This research extends the observational period for another six years, ending in 2013. Our primary hypothesis is that patient-reported clinical outcomes for ankle fusion and replacements would be similar at last follow up. Methods: Patients in the Canadian Orthopaedic Foot and Ankle Society (COFAS) Prospective Ankle Reconstructive Database were treated with total ankle replacement (involving Agilty, Star, Mobilty, Hintegra, or Inbone) or fusion (open or arthroscopic). Patient characteristics collected included demographics, comorbidities, smoking status and body mass index. Patient-reported outcomes (PROs) completed by patients were the Ankle Osteoarthritis Scale (AOS) and Short Form-36 (SF-36). Pre-operative and most recent patient data, with at least four years follow-up, were analyzed. Sensitivity analyses excluded ankles that had undergone revision. A linear mixed-effects regression model compared scores between total ankle replacement and fusion groups, adjusting for patient characteristics, baseline data and surgeon. Results: The sample included 844 ankles (556 ankle replacements and 284 arthrodesis). The mean follow up period was 8.0 years (standard deviation 3.1 years), with minimum and maximum of 4 and 14 years, respectively. Patients treated with arthrodesis were younger, more likely to be diabetic and smokers, and somewhat less likely to have inflammatory arthritis. Overall, 19.4% of ankle fusion and 30.8% of ankle replacements underwent all-cause re-operation. The mean AOS total score improved from 58.6 points pre-operatively to 31.4 post-operatively (delta 27.2), and from 57.0 to 26.9 points (delta 30.1) in the ankle replacement group. Differences in the change in AOS and SF-36 scores between the arthrodesis and ankle replacement groups were minimal after adjustment for baseline characteristics and surgeon. Conclusion: Clinical outcomes of total ankle replacement and ankle arthrodesis were comparable in a diverse cohort of patients whose follow up period ranged between 4 and 14 years post-operatively.


2019 ◽  
Vol 4 (4) ◽  
pp. 2473011419S0035
Author(s):  
William JE Reeve ◽  
Paul Dearden ◽  
Benjamin Drake ◽  
Rajeshkumar Kakwani ◽  
Murty N Aradhyula ◽  
...  

Category: Ankle, Ankle Arthritis Introduction/Purpose: The Infinity (Wright medical) total ankle replacement (TAR) has become the most implanted ankle replacement in the UK with a 30.1% share in the most recent 2016 England and Wales NJR 14th report. It is a fixed bearing implant utilising an anterior approach and radiological guidance to aid alignment, and is approved for use in the UK as an uncemented implant. Methods: Since introducing the Infinity TAR in June 2014, all implants from two centres in the UK; The Royal Devon and Exeter Hospital NHS Foundation Trust and Northumbria NHS Healthcare Trust, have been followed up prospectively. 113 implants are included with 2 year minimum follow-up, average follow-up being 33 months (24-52). Pre- and post-operative demographic, radiographic and functional outcomes were collected including Visual Analogue Score (VAS), Manchester Oxford foot questionnaire (MOxFQ, UK validated patient reported outcome score) EQ5D (validated quality of life score). Complexity was assessed using COFAS pre-operative grade. Results: Implant survivorship was 93.8% at 2 years minimum. Median age was 68 (42-92), male: female 72:41. Mean MOxFQ improved by 28, mean EQ5D by 1.4 and mean VAS by 7. 16 cases had planned additional procedures, 5 required intra-operative medial malleolar fixation. There have been 2 revisions for deep infection, 2 for implant subsidence, 1 for instability and 2 for unexplained pain (6.2%). 5 patients have required further surgery to the ankle and hindfoot with implant retention (4.4%). 3 patients have asymptomatic tibial cysts (3.4%) and 1 patient has an asymptomatic talar cyst (0.9%) - there is no evidence of progression or loosening. Conclusion: We report favourable early functional, radiographic and survivorship outcomes of this implant in the UK population.


2019 ◽  
Vol 41 (3) ◽  
pp. 275-285 ◽  
Author(s):  
Roxa Ruiz ◽  
Roman Susdorf ◽  
Nicola Krähenbühl ◽  
Alexej Barg ◽  
Beat Hintermann

Background: Mobile-bearing total ankle replacement (TAR) potentially enables motion at the tibial implant–polyethylene insert (PI) interface. Such additional freedom of movement may overload periarticular ligaments and subsequently result in coronal translation of the talus. The aim of this study was to assess whether syndesmotic overload affects clinical and radiographic outcomes following mobile-bearing TAR and whether tibiofibular fusion is an effective treatment option. Methods: Thirty-one patients who underwent revision surgery for syndesmotic overload after mobile-bearing TAR were retrospectively analyzed. Clinical and radiographic outcomes were assessed before and after index TAR, preoperatively to revision surgery, and at the last follow-up after revision surgery. Computed tomography scans were also analyzed. Results: Ankles with lateral talar translation prior to revision surgery were about 10 times more likely to have valgus tibial implant position ( P = .003). A wide tibiofibular distance at the level of the syndesmosis after index TAR was associated with an increased hindfoot moment arm at revision surgery ( P = .025). Decrease of PI height at revision surgery and a PI fracture were evident in 10 (32%) and 4 (13%) cases, respectively. Talar cyst formation at revision surgery was evident in 12 (39%) cases. Tibiofibular fusion was effective in restoring function of the replaced ankle and providing pain relief. Conclusion: Syndesmotic overload impaired clinical and radiographic outcomes after mobile-bearing TAR. Proper implant positioning and additional realignment procedures may prevent overload of periarticular soft tissue structures after mobile-bearing TAR. Level of Evidence: Level IV, retrospective case series.


2019 ◽  
Vol 41 (3) ◽  
pp. 259-266
Author(s):  
Samuel B. Adams ◽  
John R. Steele ◽  
Constantine A. Demetracopoulos ◽  
James A. Nunley ◽  
Mark E. Easley ◽  
...  

Background: Neutral ankle alignment along with medial and lateral support are paramount to the success of total ankle replacement (TAR). Fibula, intra-articular medial malleolus, and supramalleolar tibia osteotomies have been described to achieve these goals; however, the literature is scant with outcomes and union rates of these osteotomies performed concomitant to TAR. The purpose of this study was to describe our results. Methods: A retrospective review was performed to identify patients who had a concomitant tibia, fibula, or combined tibia and fibula osteotomy at the same time as TAR. Routine radiographs were used to assess osteotomy union rates and changes in alignment. Outcomes questionnaires were evaluated preoperatively and at most recent follow-up. Twenty-six patients comprising 4% of the total TAR cohort were identified with a mean follow-up of 3.9 years. Results: There were 12 combined tibia and fibula osteotomies, 9 isolated tibia osteotomies, and 5 isolated fibula osteotomies. The union rate for these osteotomies was 92%, 100%, and 100%, respectively. Mean coronal alignment improved from 15.2 to 2.1 degrees ( P < .001). There was significant improvement in patient-reported outcome scores, including Short Form-36, Short Musculoskeletal Function Assessment, and visual analog scale pain. There was 1 failure in the study. Conclusion: These data demonstrate successful use of tibia, fibula, or combined tibia and fibula osteotomies at the same time as TAR in order to gain neutral ankle alignment. The overall union rate was 96% with significant improvement in alignment, pain, and patient-reported outcomes. We believe concomitant osteotomies can be considered a successful adjunctive procedure to TAR. Level of Evidence: Level III, retrospective comparative series.


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