Hemiarthroplasty Or Total Elbow Arthroplasty in the Elderly. (NCT04646798) | Clinical Trial Compass
UnknownNot Applicable
Hemiarthroplasty Or Total Elbow Arthroplasty in the Elderly.
United Kingdom20 participantsStarted 2020-11-30
Plain-language summary
A feasibility study to assess the practicality, and obtain preliminary data to inform, a definitive Randomise Control Trial (RCT) in patients over the age of 65 diagnosed with un-reconstructible distal humeral fractures, to determine if there are differences in functional outcomes between those undergoing a hemiarthroplasty and a total elbow arthroplasty? Over an 18 month recruitment period the investigators will assess recruitment rates and participants willingness to be randomised to one of two routine clinical treatments. During a 1 year routine clinical follow up period (at 3 time points), routinely collected orthopaedic outcome data will be recorded and differences between groups explored.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged 65 or over at time of surgery
* Scheduled for operative repair by TEA or HA if fracture deemed unfixable.
* Willing and able to provide informed consent
* Willing and able to be randomly allocated to one of two surgical options
* Willing and able to return for local routine clinical follow up
Exclusion Criteria:
* Aged under 65 at time of surgery
* Patients unable to independently consent for inclusion for any reason
* Patients who have had previous elbow joint infections
* Patients who will be unable or unlikely to be able to attend for local routine clinical follow-up (e.g. foreign nationals or holidaymakers who will seek follow-up away from our centre).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recruitment rates
Timeframe: 1-18 months
Trial details
NCT IDNCT04646798
SponsorRoyal Devon and Exeter NHS Foundation Trust