A randomised, multi-centre trial of total ankle replacement versus ankle arthrodesis in the treatment of patients with end stage ankle osteoarthritis (TARVA): statistical analysis plan

Total ankle replacement has become a viable alternative to ankle arthrodesis in the surgical management of advanced ankle arthritis. Total ankle replacement has generally been reserved for patients who are older and for those who will have a lower demand on the replacement. The purpose of the current study is to review patient outcomes, complications, and implant survival in patients younger than 55 years who underwent total ankle replacement at a single institution. A single-center chart and radiographic review was performed of consecutive patients who underwent total ankle replacement for treatment of end-stage ankle arthritis. All surgeries were performed by 1 of 5 fellowship-trained foot and ankle surgeons at a single institution. A total of 51 patients met inclusion criteria with a mean follow-up of 31.2 months (SD = 16.2). Implant survival was 94%, There were 7 major complications (13%) requiring an unplanned return to the operating room and 8 minor complications (15%) that resolved with conservative care. The results of this study show that total ankle replacement is a viable treatment option for patients younger than 55 years. Levels of Evidence: A retrospective case series

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Clinical Radiographical Outcomes and Complications after a Brand-New Total Ankle Replacement Design through an Anterior Approach: A Retrospective at a Short-Term Follow Up

Journal of Clinical Medicine ◽

10.3390/jcm10112258 ◽

2021 ◽

Vol 10 (11) ◽

pp. 2258

Author(s):

Massimiliano Mosca ◽

Silvio Caravelli ◽

Emanuele Vocale ◽

Simone Massimi ◽

Davide Censoni ◽

...

Keyword(s):

Mean Value ◽

Total Ankle Replacement ◽

P Value ◽

Ankle Osteoarthritis ◽

Ankle Replacement ◽

Patient Reported ◽

End Stage ◽

Term Performance ◽

Replacement Design

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.

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Is End-Stage Ankle Arthrosis Best Managed with Total Ankle Replacement or Arthrodesis? A Systematic Review

Advances in Orthopedics ◽

10.1155/2014/986285 ◽

2014 ◽

Vol 2014 ◽

pp. 1-9 ◽

Cited By ~ 18

Author(s):

Robert W. Jordan ◽

Gurdip S. Chahal ◽

Anna Chapman

Keyword(s):

Systematic Review ◽

Functional Outcome ◽

Controlled Trial ◽

Ankle Arthrodesis ◽

Total Ankle Replacement ◽

Online Databases ◽

Ankle Replacement ◽

Comparative Group ◽

Randomised Controlled ◽

End Stage

Introduction. End-stage ankle osteoarthritis is a debilitating condition. Traditionally, ankle arthrodesis (AA) has been the surgical intervention of choice but the emergence of total ankle replacement (TAR) has challenged this concept. This systematic review aims to address whether TAR or AA is optimal in terms of functional outcomes.Methods. We conducted a systematic review according to PRISMA checklist using the online databases Medline and EMBASE after January 1, 2005. Participants must be skeletally mature and suffering from ankle arthrosis of any cause. The intervention had to be an uncemented TAR comprising two or three modular components. The comparative group could include any type of ankle arthrodesis, either open or arthroscopic, using any implant for fixation. The study must have reported at least one functional outcome measure.Results. Of the four studies included, two reported some significant improvement in functional outcome in favour of TAR. The complication rate was higher in the TAR group. However, the quality of studies reviewed was poor and the methodological weaknesses limited any definitive conclusions being drawn.Conclusion. The available literature is insufficient to conclude which treatment is superior. Further research is indicated and should be in the form of an adequately powered randomised controlled trial.

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Validation of the Ankle Osteoarthritis Scale Instrument for Preoperative Evaluation of End-Stage Ankle Arthritis Patients Using Item Response Theory

Foot & Ankle International ◽

10.1177/1071100718818573 ◽

2019 ◽

Vol 40 (4) ◽

pp. 422-429 ◽

Cited By ~ 2

Author(s):

Guiping Liu ◽

Alexander C. Peterson ◽

Kevin Wing ◽

Trafford Crump ◽

Alastair Younger ◽

...

Keyword(s):

Item Response Theory ◽

Item Response ◽

Ankle Arthrodesis ◽

Ankle Arthritis ◽

Response Theory ◽

Ankle Osteoarthritis ◽

Differential Item Function ◽

Ankle Replacement ◽

End Stage ◽

Pain Domain

Background: Significant ankle arthritis results in functional limitations and patient morbidity. There is a need to measure symptoms and the impact of interventions on patient’s quality of life using valid and reliable patient-reported measurement instruments. The objective of this research was to validate the Ankle Osteoarthritis Scale instrument in the preoperative setting using factor analysis, item response theory, and differential item function methods. Methods: This research is based on secondary analysis of patients scheduled for ankle arthrodesis or total ankle replacement in Vancouver, Canada. Participants completed the instrument between September 2014 and August 2017. Item response theory was used to estimate item difficulty and discrimination parameters, controlling for study participants’ underlying level of ankle function. Differential item function was examined for sex, age group, and surgery. There were 88 participants. Results: Modification indices suggested that item 10, “walking around the house,” would better fit the pain domain rather than the disability domain. Items in the pain domain displayed a range of discrimination and difficulty. Items in the disability domain exhibited a range of discrimination, though the disability domain had low difficulty. Differential item functioning for sex, age group, and ankle arthrodesis or total ankle replacement appeared to be ignorable. Conclusion: This evaluation of the Ankle Osteoarthritis Scale found the instrument to be a strong measure of the effect of pain and dysfunction among patients with end-stage ankle arthritis, even when removing items 7 and 8, supporting its prior use in numerous clinical studies. Level of Evidence: Level II, prospective comparative study.

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Total ankle replacement in patients with end-stage ankle osteoarthritis: Clinical results and kinetic gait analysis

Foot and Ankle Surgery ◽

10.1016/j.fas.2014.04.002 ◽

2014 ◽

Vol 20 (3) ◽

pp. 195-200 ◽

Cited By ~ 9

Author(s):

Alejandro Roselló Añón ◽

Ignacio Martinez Garrido ◽

Juan Cervera Deval ◽

Daniel Herrero Mediavilla ◽

María Sánchez González ◽

...

Keyword(s):

Gait Analysis ◽

Clinical Results ◽

Total Ankle Replacement ◽

Ankle Osteoarthritis ◽

Ankle Replacement ◽

End Stage

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Nationwide Analysis of Total Ankle Replacement and Ankle Arthrodesis in Medicare Patients: Trends, Complications, and Cost

Foot & Ankle Specialist ◽

10.1177/1938640020950181 ◽

2020 ◽

pp. 193864002095018

Author(s):

William A. Tucker ◽

Brandon L. Barnds ◽

Brandon L. Morris ◽

Armin Tarakemeh ◽

Scott Mullen ◽

...

Keyword(s):

Surgical Intervention ◽

Ankle Arthrodesis ◽

Total Ankle Replacement ◽

Complication Rates ◽

Ankle Arthritis ◽

Ankle Replacement ◽

Procedure Cost ◽

Medicare Patients ◽

Retrospective Comparative Study ◽

End Stage

Background Surgical management of end-stage ankle arthritis consists of either ankle arthrodesis (AA) or total ankle replacement (TAR). The purpose of this study was to evaluate utilization trends in TAR and AA and compare cost and complications. Methods Medicare patients with the diagnosis of ankle arthritis were reviewed. Patients undergoing surgical intervention were split into AA and TAR groups, which were evaluated for trends as well as postoperative complications, revision rates, and procedure cost. Results A total of 673 789 patients were identified with ankle arthritis. A total of 19 120 patients underwent AA and 9059 underwent TAR. While rates of AA remained relatively constant, even decreasing, with 2080 performed in 2005 and 1823 performed in 2014, TAR rates nearly quadrupled. Average cost associated with TAR was $12559.12 compared with $6962.99 for AA ( P < .001). Overall complication rates were 24.9% in the AA group with a 16.5% revision rate compared with 15.1% and 11.0%, respectively, in the TAR group ( P < .001). Patients younger than 65 years had both higher complication and revision rates. Discussion TAR has become an increasingly popular option for the management of end-stage ankle arthritis. In our study, TAR demonstrated both lower revision and complication rates than AA. However, TAR represents a more expensive treatment option. Levels of Evidence: Level III: Retrospective comparative study

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Outcomes of Total Ankle Replacement, Arthroscopic Ankle Arthrodesis, and Open Ankle Arthrodesis for Isolated Non-Deformed End-Stage Ankle Arthritis

The Journal of Bone and Joint Surgery (American) ◽

10.2106/jbjs.18.01012 ◽

2019 ◽

Vol 101 (17) ◽

pp. 1523-1529 ◽

Cited By ~ 8

Author(s):

Andrea N. Veljkovic ◽

Timothy R. Daniels ◽

Mark A. Glazebrook ◽

Peter J. Dryden ◽

Murray J. Penner ◽

...

Keyword(s):

Ankle Arthrodesis ◽

Total Ankle Replacement ◽

Ankle Arthritis ◽

Ankle Replacement ◽

End Stage

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Total Ankle Replacement for Treatment of End-Stage Osteoarthritis in Elderly Patients

Journal of Aging Research ◽

10.1155/2012/345237 ◽

2012 ◽

Vol 2012 ◽

pp. 1-8 ◽

Cited By ~ 8

Author(s):

Beat Hintermann ◽

Markus Knupp ◽

Lukas Zwicky ◽

Alexej Barg

Keyword(s):

Elderly Patients ◽

Weight Bearing ◽

Ankle Arthrodesis ◽

Total Ankle Replacement ◽

Long Term Results ◽

Postoperative Rehabilitation ◽

Early Weight Bearing ◽

Ankle Replacement ◽

First Choice ◽

End Stage

End-stage osteoarthritis of the ankle is a disabling problem, particularly in elderly patients who experience an overall loss of mobility and functional impairment and who then need compensatory adaption. Ankle arthrodesis, which has been demonstrated to provide postoperative pain relief and hindfoot stability, leaves the patient with a stiff foot and gait changes. For elderly patient, these changes may be more critical than generally believed. Additionally, the long duration of healing and rehabilitation process needed for ankle arthrodesis may be problematic in the elderly. In contrast to ankle arthrodesis, total ankle replacement has significant advantages including a less strenuous postoperative rehabilitation and preservation of ankle motion which supports physiological gait. Recently, total ankle replacement has evolved as a safe surgical treatment in patients with end-stage ankle osteoarthritis with reliable mid- to long-term results. Total ankle replacement needs less immobilization than arthrodesis and does allow for early weight-bearing and should be considered as a treatment option of first choice in many elderly patients with end-stage osteoarthritis of the ankle, especially in elderly patients with lower expectations and physical demands.

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Is ankle arthrodesis or total ankle replacement the better treatment for end stage arthrosis?

Fuß & Sprunggelenk ◽

10.1016/j.fuspru.2014.02.003 ◽

2014 ◽

Vol 12 (2) ◽

pp. 63-64 ◽

Cited By ~ 1

Author(s):

Tanja Kostuj ◽

Andy Goldberg ◽

Hakon Kofoed

Keyword(s):

Ankle Arthrodesis ◽

Total Ankle Replacement ◽

Ankle Replacement ◽

End Stage

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Two-Year Outcomes of Total Ankle Replacement with the Cadence Total Ankle Replacement System

Foot & Ankle Orthopaedics ◽

10.1177/2473011419s00156 ◽

2019 ◽

Vol 4 (4) ◽

pp. 2473011419S0015

Author(s):

Timothy R. Daniels ◽

Shahin Kayum ◽

Ryan M. Khan ◽

Anastasia Sanjevic

Keyword(s):

Total Ankle Replacement ◽

Total Ankle Arthroplasty ◽

X Rays ◽

Ankle Osteoarthritis ◽

Ankle Arthroplasty ◽

Post Surgery ◽

Ankle Replacement ◽

Two Component ◽

Replacement System ◽

End Stage

Category: Ankle, Ankle Arthritis Introduction/Purpose: Over the last few decades, total ankle replacement (TAR) emerged as a reliable treatment option in end-stage ankle osteoarthritis (OA) while preserving motion and physiological load. The Cadence™ prosthesis, manufactured by Integra LifeSciences, is a two-component, fixed-bearing implant with minimal tibial and talar resection and has been in clinical use since June 2016. The purpose of this study is to assess the two-year validated clinical outcome scores and radiological parameters of the Cadence™ prosthesis at our hospital. Methods: Thirty-one consecutive patients who received the Cadence™ prosthesis between June 2016 and December 31st, 2016 were enrolled. All patients who underwent a primary TAR with the Cadence™ prosthesis and who had at least two years follow- up were included. All surgeries were performed by a single surgeon with experience in total ankle arthroplasty. At the yearly clinical evaluation, patients were administered the Ankle Osteoarthritis Scale (AOS) and the Short Form Health Survey (SF-36), and their radiological outcomes pre and post-surgery were assessed. Results: Thirty-one patients fulfilled the inclusion criteria. Forty ancillary procedures were performed on twenty-four TAR’s. Radiological analyses showed preoperative talar sagittal translation with 25 anterior, 2 posterior, and 4 neutral. Sagittal translation decreased from an average 3.11 mm to 1.0 mm. Eleven ankles had a perioperative talar Varus and Valgus deformity that was corrected, with neutral alignment in all. At the two-year clinic visit, x-rays showed no lucencies or stress fractures and none of the ankles required revision of metal components. The pre and post-operative pain and disability scores displayed major improvement wherein AOS pain scores decreased -20.28 ± 14.34 points from an average of 47.86 points while AOS disability scores decreased -32.11 ± 22.70 from an average of 57.15 points. Conclusion: The overall outcome of the total ankle arthroplasty with the Cadence™ prosthesis showed excellent clinical and radiological outcomes. Compelling clinical evidence shows that the quality of life, functional measures, and pain in patients suffering from end-stage arthritis significantly improved following surgery with the Cadence™ total ankle replacement system. The semi- constrained design of this two-component implant and utilization of biased polyethylene inserts allowed for correction of the talus in both the sagittal (talar anterior / posterior translation) and coronal planes (talar varus / valgus).

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