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Health Technology Assessment... Mar 2023We aimed to compare the clinical effectiveness, cost-effectiveness and complication rates of total ankle replacement with those of arthrodesis (i.e. ankle fusion) in the...
BACKGROUND
We aimed to compare the clinical effectiveness, cost-effectiveness and complication rates of total ankle replacement with those of arthrodesis (i.e. ankle fusion) in the treatment of end-stage ankle osteoarthritis.
METHODS
This was a pragmatic, multicentre, parallel-group, non-blinded randomised controlled trial. Patients with end-stage ankle osteoarthritis who were aged 50-85 years and were suitable for both procedures were recruited from 17 UK hospitals and randomised using minimisation. The primary outcome was the change in the Manchester-Oxford Foot Questionnaire walking/standing domain scores between the preoperative baseline and 52 weeks post surgery.
RESULTS
Between March 2015 and January 2019, 303 participants were randomised using a minimisation algorithm: 152 to total ankle replacement and 151 to ankle fusion. At 52 weeks, the mean (standard deviation) Manchester-Oxford Foot Questionnaire walking/standing domain score was 31.4 (30.4) in the total ankle replacement arm ( = 136) and 36.8 (30.6) in the ankle fusion arm ( = 140); the adjusted difference in the change was -5.6 (95% confidence interval -12.5 to 1.4; = 0.12) in the intention-to-treat analysis. By week 52, one patient in the total ankle replacement arm required revision. Rates of wound-healing issues (13.4% vs. 5.7%) and nerve injuries (4.2% vs. < 1%) were higher and the rate of thromboembolic events was lower (2.9% vs. 4.9%) in the total ankle replacement arm than in the ankle fusion arm. The bone non-union rate (based on plain radiographs) in the ankle fusion arm was 12.1%, but only 7.1% of patients had symptoms. A post hoc analysis of fixed-bearing total ankle replacement showed a statistically significant improvement over ankle fusion in Manchester-Oxford Foot Questionnaire walking/standing domain score (-11.1, 95% confidence interval -19.3 to -2.9; = 0.008). We estimate a 69% likelihood that total ankle replacement is cost-effective compared with ankle fusion at the National Institute for Health and Care Excellence's cost-effectiveness threshold of £20,000 per quality-adjusted life-year gained over the patient's lifetime.
LIMITATIONS
This initial report contains only 52-week data, which must therefore be interpreted with caution. In addition, the pragmatic nature of the study means that there was heterogeneity between surgical implants and techniques. The trial was run across 17 NHS centres to ensure that decision-making streams reflected the standard of care in the NHS as closely as possible.
CONCLUSIONS
Both total ankle replacement and ankle fusion improved patients' quality of life at 1 year, and both appear to be safe. When total ankle replacement was compared with ankle fusion overall, we were unable to show a statistically significant difference between the two arms in terms of our primary outcome measure. The total ankle replacement versus ankle arthrodesis (TARVA) trial is inconclusive in terms of superiority of total ankle replacement, as the 95% confidence interval for the adjusted treatment effect includes both a difference of zero and the minimal important difference of 12, but it can rule out the superiority of ankle fusion. A post hoc analysis comparing fixed-bearing total ankle replacement with ankle fusion showed a statistically significant improvement of total ankle replacement over ankle fusion in Manchester-Oxford Foot Questionnaire walking/standing domain score. Total ankle replacement appears to be cost-effective compared with ankle fusion at the National Institute for Health and Care Excellence's cost-effectiveness threshold of £20,000 per quality-adjusted life-year gained over a patient's lifetime based on long-term economic modelling.
FUTURE WORK
We recommend long-term follow-up of this important cohort, in particular radiological and clinical progress. We also recommend studies to explore the sensitivity of clinical scores to detect clinically important differences between arms when both have already achieved a significant improvement from baseline.
TRIAL REGISTRATION
This trial is registered as ISRCTN60672307 and ClinicalTrials.gov NCT02128555.
FUNDING
This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 27, No. 5. See the NIHR Journals Library website for further project information.
Topics: Humans; Arthroplasty, Replacement, Ankle; Ankle; Quality of Life; Osteoarthritis; Cost-Benefit Analysis; Arthrodesis; Randomized Controlled Trials as Topic; Multicenter Studies as Topic
PubMed: 37022932
DOI: 10.3310/PTYJ1146 -
Foot & Ankle Orthopaedics Jul 2022End-stage ankle osteoarthritis often requires one of 2 major surgical procedures: total ankle arthroplasty or ankle arthrodesis. Although the gold standard has been...
BACKGROUND
End-stage ankle osteoarthritis often requires one of 2 major surgical procedures: total ankle arthroplasty or ankle arthrodesis. Although the gold standard has been arthrodesis, patients with diabetes represent a unique cohort that requires additional considerations because of their decreased mobility and risk factors for cardiovascular complications. The purpose of this study is to review odds of major and minor adverse events for patients with diabetes and patients without diabetes in both total ankle arthroplasty and ankle arthrodesis.
METHODS
A total of 14 articles published between 2010 and 2020 were included in this review. Databases included PubMed, Scopus, MEDLINE/Embase, and Cochrane Library. Key words included ankle arthroplasty, total ankle arthroplasty, ankle arthrodesis, and diabetes.
RESULTS
The total number of procedures was 26 287, comprising 13 830 arthroplasty and 12 457 arthrodesis procedures. There was a significant association between patients with diabetes treated with arthrodesis and major adverse events (odds ratio [OR] 1.880, 95% CI 1.279, 2.762), whereas no significant association was observed between patients with diabetes treated with arthroplasty and major adverse events (OR 1.106, 95% CI 0.871, 1.404).
CONCLUSION
This meta-analysis suggests patients with diabetes to be at significantly higher risk for major and minor adverse events after undergoing ankle arthrodesis. However, it suggests no significant differences in major adverse events between patients with diabetes and patients without diabetes having undergone total ankle arthroplasty.
LEVEL OF EVIDENCE
Level III, systematic review and meta-analysis.
PubMed: 35924005
DOI: 10.1177/24730114221112955 -
Journal of Wrist Surgery Nov 2018End-stage wrist arthritis has traditionally been treated with a total wrist fusion. There is a recent trend toward motion preserving surgery in the form of total...
End-stage wrist arthritis has traditionally been treated with a total wrist fusion. There is a recent trend toward motion preserving surgery in the form of total wrist replacement. Is there a functional benefit to performing a total wrist replacement instead of a total wrist fusion in patients with end-stage wrist arthritis? Is there any difference in secondary outcome measures including pain, grip strength, and range of motion? Does the risk of adverse events and treatment failure differ between the two techniques? A systematic literature search was performed to identify studies reporting either total wrist arthrodesis or arthroplasty for end-stage wrist arthritis. Studies were systematically screened and assessed for risk of bias and quality. Data were extracted and reviewed. A total of 43 studies were included in the review: 17 on arthrodesis, 24 on arthroplasty, and 2 matched cohort studies. This represented 669 index arthrodesis operations in 603 patients, and 1,371 index arthroplasty operations in 1,295 patients. A significant improvement in functional outcome was seen with both interventions. Similar improvements were seen in pain scores, and modest improvements were seen in grip strength. Range of motion following arthroplasty improved to a functional level in two studies. Complication rates were higher after arthroplasty (range: 0.2-9.5%) than those after arthrodesis (range: 0.1-6.1%; = 0.06). Fourth-generation implants (range 0.1-2.9%) performed better than earlier designs (range: 0.2-8.1%; = 0.002). Implant revision rates ranged from 3.5 to 52.6%. Fourth-generation prostheses survival rates were 78% at 15 years (Universal 2), 86% at 10 years (Motec), 90% at 9 years (Re-Motion), and 95% at 8 years (Maestro). The newer fourth-generation wrist implants appear to be performing better than earlier designs. Both wrist arthrodesis and wrist arthroplasty improve function, pain, and grip strength. The risk of complication following wrist replacements is higher than that after total wrist arthrodesis.
PubMed: 30349758
DOI: 10.1055/s-0038-1646956 -
European Journal of Radiology Nov 2022Many studies have been performed that investigate consolidation after arthrodesis of foot and ankle joints. Consolidation in foot and ankle joints is best assessed by... (Review)
Review
PURPOSES
Many studies have been performed that investigate consolidation after arthrodesis of foot and ankle joints. Consolidation in foot and ankle joints is best assessed by computed tomography (CT). However, no golden-standard methodology exists for radiological consolidation assessment from CT after ankle and foot arthrodesis. The aim of this review is to present an overview of the radiological methodologies for consolidation assessment, outcomes on reliability and validity and to advise which methodology should be used.
METHOD
Scientific databases were systematically searched. Eligible studies were studies that 1) performed foot or ankle arthrodesis, 2) mentioned radiological or CT follow-up in abstract, 3) performed postoperative CT in > 50% of patients. Two authors selected eligible studies and performed a risk of bias assessment with the COSMIN tool.
RESULTS
Risk of bias assessment showed that most studies (80%) were at high risk of bias due to poor methodology. The most popular method for consolidation assessment is by subjectively categorizing consolidation into consolidation groups, with a substantial reliability score. Another popular method is to calculate the fusion ratio and then apply a fusion threshold, to distinguish between fused and non-fused joints. This method had an excellent reliability score. In most studies a fusion threshold of 50% is used. However, four studies in this review showed that a 30% fusion threshold may by more valid.
CONCLUSION
Based on the results of this review we would advise to calculate fusion threshold and apply a 30% fusion threshold to distinguish fused from non-fused foot and ankle joints.
PubMed: 36108477
DOI: 10.1016/j.ejrad.2022.110511 -
The Journal of Hand Surgery, European... Mar 2021Surgical management of end-stage rheumatoid wrists is a contentious topic. The standard surgical treatment has traditionally been wrist arthrodesis. Wrist arthroplasty,...
Surgical management of end-stage rheumatoid wrists is a contentious topic. The standard surgical treatment has traditionally been wrist arthrodesis. Wrist arthroplasty, however, offers an alternative that preserves some wrist motion. A systematic review of MEDLINE, EMBASE and CENTRAL databases was conducted. Data from 23 studies representing 343 cases of wrist arthrodesis and 618 cases of wrist arthroplasty were included. Complication rates were 17% for arthrodesis and 19% for arthroplasty, and both procedures were effective at alleviating pain and improving grip strength. Functional assessment by Disabilities of the Arm, Shoulder, and Hand and Patient-Related Wrist Evaluation of arthroplasty patients revealed clinically meaningful functional improvement compared with preoperative measurements. In contrast to previously published findings both procedures demonstrated comparable complication rates. While this can be speculated to be from advancements in prosthetics, robust long-term follow-up data on wrist arthroplasty are not available yet.
Topics: Arthritis, Rheumatoid; Arthrodesis; Arthroplasty; Follow-Up Studies; Humans; Treatment Outcome; Wrist; Wrist Joint
PubMed: 32938290
DOI: 10.1177/1753193420953683 -
Hand (New York, N.Y.) Jan 2023Proximal interphalangeal joint (PIPJ) arthrodesis is a salvage option in the management of end-stage PIPJ arthropathy. Numerous techniques have been described, including... (Review)
Review
Proximal interphalangeal joint (PIPJ) arthrodesis is a salvage option in the management of end-stage PIPJ arthropathy. Numerous techniques have been described, including screws, Kirschner wires, tension band wiring, intramedullary devices, and plate fixation. There remains no consensus as to the optimum method, and no recent summary of the literature exists. A literature search was conducted using the MEDLINE, EMBASE, and PubMed databases. English-language articles reporting PIPJ arthrodesis outcomes were included and presented in a systematic review. Pearson χ and 2-sample proportion tests were used to compare fusion time, nonunion rate, and complication rate between arthrodesis techniques. The mean fusion time ranged from 5.1 to 12.9 weeks. There were no statistically significant differences in fusion time between arthrodesis techniques. Nonunion rates ranged from 0.0% to 33.3%. Screw arthrodesis demonstrated a lower nonunion rate than wire fusion (3.0% and 8.5% respectively; = .01). Complication rates ranged from 0.0% to 22.1%. Aside from nonunions, there were no statistically significant differences in complication rates between arthrodesis techniques. The available PIPJ arthrodesis techniques have similar fusion time, nonunion rate, and complication rate outcomes. The existing data have significant limitations, and further research would be beneficial to elucidate any differences between techniques.
Topics: Humans; Bone Wires; Bone Screws; Arthrodesis; Joint Diseases; Finger Joint
PubMed: 33682483
DOI: 10.1177/1558944721998019 -
BMJ Open Nov 2016Systematic review and meta-analysis of published observational cohort studies. To quantify the increased risk smokers have of experiencing a delayed and/or non-union in... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVES
Systematic review and meta-analysis of published observational cohort studies. To quantify the increased risk smokers have of experiencing a delayed and/or non-union in fractures, spinal fusion, osteotomy, arthrodesis or established non-unions.
SETTING
Medical Literature Analysis and Retrieval System Online (MEDLINE), Excerpta Medica database (EMBASE), Allied and Complementary Medicine Database (AMED) and Web of Science Core Collection from 1966 to 2015.
STUDY ELIGIBILITY CRITERIA, PARTICIPANTS AND INTERVENTIONS
Observational cohort studies that reported adult smokers and non-smokers with delayed and/or non-union or time to union of the fracture, spinal fusion, osteotomy, arthrodesis or established non-union were eligible.
DATA EXTRACTION AND OUTCOME MEASURES
2 authors screen titles, abstracts and full papers. Data were extracted by 1 author and checked independently by a second. The relative risk ratios of smoking versus non-smoking and the mean difference in time to union patients developing a delayed and/or non-union were calculated.
RESULTS
The search identified 3013 articles; of which, 40 studies were included. The meta-analysis of 7516 procedures revealed that smoking is linked to an increased risk of delayed and/or non-union. When considered collectively, smokers have 2.2 (1.9 to 2.6) times the risk of experiencing delayed and/or non-union. In all the subgroups, the increased risk was always ≥1.6 times that of non-smokers. In the patients where union did occur, it was a longer process in the smokers. The data from 923 procedures were included and revealed an increase in time to union of 27.7 days (14.2 to 41.3).
CONCLUSIONS
Smokers have twice the risk of experiencing a non-union after fracture, spinal fusion, osteotomy, arthrodesis or treatment of non-union. Time to union following fracture, osteotomy, arthrodesis or treatment of an established non-union is longer in smokers. Smokers should be encouraged to abstain from smoking to improve the outcome of these orthopaedic treatments.
Topics: Arthrodesis; Fracture Healing; Fractures, Bone; Fractures, Malunited; Fractures, Ununited; Humans; Osteotomy; Postoperative Complications; Risk Factors; Smoking; Surgical Wound Infection
PubMed: 28186922
DOI: 10.1136/bmjopen-2015-010303 -
The Journal of Hand Surgery Jun 2023Several limited midcarpal arthrodeses have been used in the treatment of midcarpal osteoarthritis as part of scapholunate advanced collapse and scaphoid nonunion...
PURPOSE
Several limited midcarpal arthrodeses have been used in the treatment of midcarpal osteoarthritis as part of scapholunate advanced collapse and scaphoid nonunion advanced collapse. There is no consensus on whether two-carpal arthrodesis (2CA), three-carpal arthrodesis (3CA), bicolumnar arthrodesis, or four-carpal arthrodesis (FCA) results in the best outcomes. The objective of this study was to determine whether there is a difference in outcomes in patients undergoing FCA, 3CA, 2CA, or bicolumnar arthrodesis for midcarpal osteoarthritis.
METHODS
A systematic review and meta-analysis were performed in multiple databases following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Studies reporting the four surgical techniques were included. The primary outcomes were postoperative visual analog scale pain score, the Disabilities of the Arm, Shoulder, and Hand score, and the Mayo Wrist Score. The secondary outcomes were active range of motion, grip strength, and reported complications.
RESULTS
Of 2,270 eligible studies, 80 articles were selected, including a total of 2,166 wrists. The visual analog scale pain scores for both the 2CA and FCA groups reached an adequate pain reduction based on the Patient Acceptable Symptom Scale. The Disabilities of the Arm, Shoulder, and Hand score was also comparable between these two groups. The 2CA group also showed a significantly better active range of motion than the FCA group for both flexion-extension and radioulnar deviation arc. The incidence of nonunion was 6.9% in the FCA group compared with 10.0% in the 2CA group.
CONCLUSIONS
Although the 2CA procedure has a theoretical advantage over the FCA method, the analysis of data showed that generally, these techniques have similar outcomes and complications. Therefore, both (2CA and FCA) are good options for midcarpal osteoarthritis in scapholunate advanced collapse and scaphoid nonunion advanced collapse wrists.
TYPE OF STUDY/LEVEL OF EVIDENCE
Therapeutic IV.
PubMed: 37278675
DOI: 10.1016/j.jhsa.2023.04.018 -
Foot and Ankle Surgery : Official... Feb 2022Arthrodesis and metallic hemiarthroplasty are two surgical interventions for the treatment of end-stage osteoarthritis of the first metatarsophalangeal (MTP1) joint.... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Arthrodesis and metallic hemiarthroplasty are two surgical interventions for the treatment of end-stage osteoarthritis of the first metatarsophalangeal (MTP1) joint. This systematic review and meta-analysis aims to compare the two operations with regards to patient-reported outcomes, pain reduction, complications and revision rates.
METHODS
A systematic literature search identified all relevant studies. The methodological quality was assessed using two validated tools. Data of interest were derived and presented. For non-comparative studies, data was assessed for trends, while for comparative studies pooling statistics were performed.
RESULTS
A total of 33 studies were included for analysis. The majority of studies (>75%) reported an AOFAS-HMI score greater than 80 points after both metallic hemiarthroplasty and arthrodesis. The lowest VAS pain score was observed after arthrodesis (weighted mean difference -1.58, 95% confidence interval (CI) -2.16 to -1.00 P< 0.00001). Comparable numbers of complications (odds radio 1.48, 95% CI 0.81 to 2.73, P = 0.21, favoring: hemiarthroplasty) and revisions (odds ratio 1.16, 95% CI 0.62 to 2.15 P = 0.64, favoring: hemiarthroplasty) were observed after both interventions. The included non-comparative studies seem to confirm these findings of the comparative studies.
CONCLUSION
Metallic hemiarthroplasty and arthrodesis have excellent clinical outcomes and acceptable complication- and revision rates. Arthrodesis seems to be superior in pain reduction, while metallic hemiarthroplasty is a suitable alternative for patients performing activities that requires motion in the first metatarsophalangeal joint.
Topics: Arthrodesis; Follow-Up Studies; Hallux Rigidus; Hemiarthroplasty; Humans; Metatarsophalangeal Joint; Retrospective Studies; Treatment Outcome
PubMed: 33812802
DOI: 10.1016/j.fas.2021.03.004 -
BMC Surgery Jul 2023Considering the high reoperation rate in degenerative lumbar spondylolisthesis (DLS) patients undergoing lumbar surgeries and controversial results on the risk factors... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Considering the high reoperation rate in degenerative lumbar spondylolisthesis (DLS) patients undergoing lumbar surgeries and controversial results on the risk factors for the reoperation, we performed a systematic review and meta-analysis to explore the reoperation rate and risk factors for the reoperation in DLS patients undergoing lumbar surgeries.
METHODS
Literature search was conducted from inception to October 28, 2022 in Pubmed, Embase, Cochrane Library, and Web of Science. Odds ratio (OR) was used as the effect index for the categorical data, and effect size was expressed as 95% confidence interval (CI). Heterogeneity test was performed for each outcome effect size, and subgroup analysis was performed based on study design, patients, surgery types, follow-up time, and quality of studies to explore the source of heterogeneity. Results of all outcomes were examined by sensitivity analysis. Publication bias was assessed using Begg test, and adjusted using trim-and-fill analysis.
RESULTS
A total of 39 cohort studies (27 retrospective cohort studies and 12 prospective cohort studies) were finally included in this systematic review and meta-analysis. The overall results showed a 10% (95%CI: 8%-12%) of reoperation rate in DLS patients undergoing lumbar surgeries. In surgery types subgroup, the reoperation rate was 11% (95%CI: 9%-13%) for decompression, 10% (95%CI: 7%-12%) for fusion, and 9% (95%CI: 5%-13%) for decompression and fusion. An increased risk of reoperation was found in patients with obesity (OR = 1.91, 95%CI: 1.04-3.51), diabetes (OR = 2.01, 95%CI: 1.43-2.82), and smoking (OR = 1.51, 95%CI: 1.23-1.84).
CONCLUSIONS
We found a 10% of reoperation rate in DLS patients after lumbar surgeries. Obesity, diabetes, and smoking were risk factors for the reoperation.
Topics: Humans; Reoperation; Spondylolisthesis; Retrospective Studies; Prospective Studies; Treatment Outcome; Spinal Stenosis; Decompression, Surgical; Spinal Fusion; Risk Factors; Lumbar Vertebrae; Diabetes Mellitus; Obesity
PubMed: 37407952
DOI: 10.1186/s12893-023-02082-8