Hintermann Series H2 Fixed and H3 Mobile-Bearing Total Ankle Replacement Systems

Author(s):  
James M. Cottom ◽  
Charles A. Sisovsky
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


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.


Orthopedics ◽  
2017 ◽  
Vol 40 (3) ◽  
pp. e567-e573 ◽  
Author(s):  
Federico G. Usuelli ◽  
Camilla Maccario ◽  
Riccardo D'Ambrosi ◽  
Michele F. Surace ◽  
Ettore Vulcano

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.


2014 ◽  
Vol 24 (6) ◽  
pp. 897-903 ◽  
Author(s):  
Keiji Iwamoto ◽  
Kenrin Shi ◽  
Tetsuya Tomita ◽  
Jun Hashimoto ◽  
Takaharu Yamazaki ◽  
...  

2017 ◽  
Vol 23 (2) ◽  
pp. 76-83 ◽  
Author(s):  
Federico G. Usuelli ◽  
Camilla Maccario ◽  
Andrea Pantalone ◽  
Nicola Serra ◽  
Eric W. Tan

2015 ◽  
Vol 36 (9) ◽  
pp. 1038-1044 ◽  
Author(s):  
C. Thomas Haytmanek ◽  
Christopher Gross ◽  
Mark E. Easley ◽  
James A. Nunley

2015 ◽  
Vol 37 (3) ◽  
pp. 281-287 ◽  
Author(s):  
Federico G. Usuelli ◽  
Camilla Maccario ◽  
Luigi Manzi ◽  
Eric W. Tan

2019 ◽  
Vol 4 (4) ◽  
pp. 2473011419S0036
Author(s):  
Roxa Ruiz ◽  
Christine Schweizer ◽  
Nicola Krähenbühl ◽  
Beat Hintermann

Category: Ankle, Ankle Arthritis Introduction/Purpose: The interface between the polyethylene (PE) inlay and the tibial component in mobile-bearing total ankle replacement (TAR) systems may allow the talus to seek its position according to the individual anatomy. However, chronic overload and/or incompetence of soft tissue may allow medial and/ or lateral translation of the talar component over time. This typically results in medial and/ or lateral gutter pain as well as pain along the syndesmosis. The purpose of this study was to assess the effect of tibial component exchange and conversion from a mobile-bearing into a fixed-bearing TAR system in patients with coronal plane instabilities TAR. Methods: A consecutive series of 30 ankles (29 patients; age 65.6 [48.9 – 86.1]; male, 23; female, 7) with coronal plane instabilities underwent revision TAR with exchange of a mobile-bearing (Hintermann Series, H3) into a fixed-bearing (Hintermann Series, H2) TAR system. Patients presented with a medial (n = 12) or lateral (n = 9) translation of the talar component, or a varus (n = 4) or valgus (n = 5) instability with subsequent tilt of the talar component. After removing the tibial component and PE inlay, a tibial osteotomy was performed and 1 to 2 mm of the distal tibia removed. A tibial component of the H2 total ankle system was inserted. While holding the foot in neutral position, the PE inlay was locked to the tibial component in the appropriate position. Functional outcome and pain were recorded to evaluate clinical outcome, and standard radiographs under fluoroscopy were taken for radiographic assessment. Results: All but one of the remaining 28 patient showed significant improvement of pain (P<0.05). Preoperative gutter pain disappeared completely in 20 ankles (71.4%), and partially in 8 ankles (18.6%). The AOFAS Hindfoot Score improved from 54.3 (range, 21 to 90) preoperatively to 74.0 (range, 48 to 92) at latest follow-up (P<0.05). Radiographic assessment showed firm osteointegration in all patients with the talar component centralized in the ankle mortise, and a free medial and lateral gutter without tilt of talar component (Figure 1). One patient with bilateral revision TAR was affected by a bilateral deep infection of both ankles 9 months after surgery subsequent to a severe pneumonia. Both ankles were removed and replaced by a cement spacer. Conclusion: Converting a mobile-bearing into a fixed-bearing TAR system has shown to be effective in the treatment of patients with coronal plane instabilities following TAR. Allowing the PE inlay to adapt its position according to the talar component before definitive fixation to the tibial component of the H2 series, saved having to replace the talar component. Future long-term studies however are needed to identify significant benefits of this novel total ankle concept in primary and revision TAR.


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