Outcomes after total elbow arthroplasty
Research type
Research Study
Full title
Outcomes after total elbow arthroplasty using the Latitude elbow prosthesis: A 2-year observational study.
IRAS ID
288056
Contact name
Lindsay Cunningham
Contact email
Duration of Study in the UK
0 years, 7 months, 24 days
Research summary
Patients who have undergone a total elbow replacement using a particular type of implant (the Latitude EV convertible elbow joint prosthesis, Wright medical) a minimum of 2 years ago will be invited to take part in the study.
At their 2-year annual review, patients will undergo their routine assessment with their treating surgeon and routine annual X-Rays. They will then be approached to invite them to take part in the study. If they agree to be part of the study, we will ask them to also complete a series of patient reported outcome measures, to provide some information about their hand dominance and leisure activities and, if they agree, their elbow range of movement will also be manually measured by a member of the team.
At the host unit, all patients complete patient reported outcome measures prior to their surgical procedure and are reviewed annually for the first 3 years. If any eligible patients are identified for inclusion by the care team, but they have already undergone their 2-year annual review, they will be contacted by the direct care team to invite them to be part of the study by post. If they wish to take part, they will be invited to a single visit at the host hospital so that the patient reported outcome measures may be completed and their range of movement can be measured. They will not require any additional X-Rays as these will already have been performed as part of their 2-year annual review.
The main aim of this study is to establish how well these implants last (survival of the implant) and whether the way in which the surgeon dealt with the radial head has any impact over the outcomes.Results Summary
Total elbow arthroplasty is a relatively infrequent surgery. As such it is under-reported in the literature compared to other forms of joint replacement. The aim of the research was to present the mid-term outcomes for the Latitude prosthesis used at WWL including the patient reported outcomes and rates of revision. We also aimed to examine the impact of tourniquet use and the superiority of radial head retention or resection.Our study has presented the outcomes for this joint replacement as planned. The planned sub-group analysis was completed however the statistical power was limited by the numbers of cases available for the study.
Following the identification and REC submission of a ‘Serious Breach’, a cohort of patient’s data had to be removed from the final analysis.The study time frame had to be extended to allow completion of recruitment and gathering PROM data. As such the duration of follow up was longer than anticipated (average of 5 years).
Investigators involved in the study changed due to the time frame of data collection and staff members leaving WWL. The recruitment of patients and gathering data, in particular Xrays and physical examination findings, was made more difficult by the number of patients that were not local to WWL.
The initial results support the use of the Latitude prosthesis and provided outcome results that can help surgeons and patients in decision making. There were no differences found when tourniquets were or were not used and between different ways of managing the radial head, suggesting that the option with the lowest complication rate may be best.
However, following the identification and REC submission of a ‘Serious Breach’ a cohort of patient’s data had to be removed from the final analysis and this did not have the statistical power to enable the results to be published.This research is most relevant to clinical decision making at the individual level for both patients and surgeons.
There are relatively few papers presenting the midterm outcomes of elbow arthroplasty and only one other that we are aware of for this prosthesis. The results are comparable. There is no other work looking at tourniquets. Other evidence into radial head choice has shown high complication rates with radial head replacement. Our work on radial head resection or retention, offer good results without the risks of replacement.
No further work stimulated currently.REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
20/NW/0380
Date of REC Opinion
14 Oct 2020
REC opinion
Further Information Favourable Opinion