Hot Elbow study
Research type
Research Study
Full title
Hemiarthroplasty Or Total elbow arthroplasty for unreconstructible distal humerus fractures in the elderly (HoT Elbow): a feasibility study
IRAS ID
289910
Contact name
Christopher Smith
Contact email
Sponsor organisation
RD&E NHS FT
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
If someone breaks their upper arm bone (humerus) it can sometimes break in several pieces. This can cause extra problems if it happens at the lower end of the bone at the elbow joint. This is difficult to fix and may need removal and replacement of the damaged bone (an implant).
For this group of patients, who need a replacement there are two treatments available. The choice of which implant is used currently only depends on the surgeons preference. Both are good implants, but we do not know which implant has the best outcomes.The two treatments offered are:
- a Hemi Arthroplasty (HA) of the elbow, where the surgeon will replace just the bottom of the humerus bone at the elbow
- a Total Elbow Arthroplasty (TEA), where the surgeon will fit a complete new elbow joint and replace both the bottom of the humerus and the top of the forearm bone (ulna)As we do not really know which is better for patients in the long term, we need a detailed study with large numbers of patients to find this out. Before we can do this type of study we need to see if it would actually be possible to run such a study (this is called a feasibility study).
Therefore we want to first see how many people over 65 years old who need treatment for a broken upper arm would: - be willing to join the study (how many could we recruit) - let us randomly assign them to one treatment or other (be willing to have an equal chance of getting into one group or the other)
- allow us to explore what differences there may be between the groups at different time points over a year (e, g pain, infection, mobility).REC name
Wales REC 7
REC reference
20/WA/0295
Date of REC Opinion
3 Nov 2020
REC opinion
Favourable Opinion