WELBOW
Research type
Research Study
Full title
WELBOW – WRIGHT™ Elbow Outcomes Clinical Study
IRAS ID
266531
Contact name
A.C. Watts
Contact email
Sponsor organisation
Wright Medical Group N.V.
Clinicaltrials.gov Identifier
Duration of Study in the UK
12 years, 0 months, 1 days
Research summary
Research Summary
The WELBOW study is an International, ambispective and prospective, single arm, multicenter, observational, non-comparative, Post-Market Clinical Follow-up (PMCF) study.
The objective of this multi-center study is to collect preoperative, intraoperative, short, intermediate, mid-term and long-term data on the related clinical complications and functional outcomes of market-approved Wright Medical Elbow products to demonstrate safety and performance of these implants in a real-world setting.
Summary of Results
The objective of this international, ambispective and, prospective, single arm, multicenter, observational, non-comparative, Post-Market Clinical Follow-up (PMCF) was to collect pre-operative, intra-operative, short (1y), intermediate (2y), mid-term (5y), and long-term (10) data on the related clinical complications, and clinical outcomes of commercially available elbow products studied in this clinical investigation to demonstrate the safety and performance of these implants in a real-world setting.
The first patient enrolled in the study on 24 March 2020. The study was conducted in 9 International centers in Europe and Canada:
• 001 - Pr ADAM WATTS / Wrightington Hospital, UK
• 002 - Dr MIKAEL ETZNER / Sjukhuset Varberg Hospital, Sweden
• 003 - Pr ADOLFSSON LARS / Linköping University, Sweden
• 005 - Pr FABRICE DUPARC / Rouen Hospital (CHU de Rouen), France
• 007 - Dr GRAHAM KING / Lawson Health Research Institute, Canada
• 008 - Dr FREDERIC DE SCHRIJVER / AZ Herentals Hospital, Belgium
• 009 - Pr GUILLAUME BACLE / Tours Hospital (CHU Tours), France
• 010 - Dr CHRISTOPHE RIZZO / Clinique du Parc, France
• 011 - Dr ALEXANDRA ERBLAND / Bordeaux Hospital (CHU Bordeaux), France
Due to the wide availability of comprehensive data for each device from external registries and published literature, which could support the predefined objectives of the study, the study was terminated early at the end of 2024. At the time of the database lock for this final report, 328 subjects across the 9 sites in Europe and Canada were enrolled in this clinical investigation and entered into the EDC system. Out of these subjects, 310 enrolled subjects are considered Per Protocol (PP) and analyzed for the purposes of this final Report. However, because the majority of subjects had not reached their 5-, 7- or 10-year visits at the time of study termination, summary data for these time points was either limited or not available.
Except for the Latitude™ EV Total device, the minimum required sample size was not achieved for the following devices, limiting the ability to conduct a meaningful primary endpoint analysis: Floating Radial Head (CRF II), Radial Head System (RHS™), Latitude™ Hemi, Latitude™ Total, Latitude™ EV Hemi, MoPyc™, Evolve™ EPS Ortholoc™, and Evolve™ PROLINE.
Based on the 24-month total Quick-DASH scores, the Wilcoxon signed rank test (normality not assumed) demonstrated statistically significant evidence of superiority for the Latitude™ EV Total device (p < 0.0001; one-sided 95% upper bound: 38.0). Additionally, it was the only device that permitted a valid baseline comparison, which also showed statistically significant superiority (p < 0.001; one-sided 95% upper bound: –24.7) using the same non-parametric method.
For other devices, the Quick-DASH results indicate a trend toward a superior Total Quick-DASH score at 24 months, and tendency to good short-term (approx. 1 year port-op) and intermediate-term (approx. 2 years post-op) results on clinical outcomes, such as performance scores, range of motion, strength, and safety.
While data was not sufficient to evaluate the primary and secondary endpoints for most of the devices, the available data was considered meaningful and is indicative that the devices are performing as intended. Regardless of the length of follow-up, all safety events were captured and assessed up to study closure. There were no new or unknown risks identified.REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
20/NW/0444
Date of REC Opinion
20 Jan 2021
REC opinion
Further Information Favourable Opinion