Pyrocarbon interposition arthroplasty of the elbow
Research type
Research Study
Full title
A prospective case series to evaluate the safety and acceptability of a novel surgical technique of pyrocarbon interposition arthroplasty of the elbow, in young patients with severe arthritis.
IRAS ID
277582
Contact name
Adam Watts
Contact email
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 11 months, 31 days
Research summary
This study will be a prospective case series of patients with severe arthritis who have severe elbow joint pain and loss of function, but who are unsuitable for total elbow replacement due to their high functional demands. Eligible patients will be offered the opportunity to be part of the study. Consenting patients will undergo a novel procedure to the elbow involving resection of the bone ends and insertion of a pyrocarbon sphere with the aim of restoring pain free elbow movement. These pyrocarbon spheres are usually used in the hand, wrist and foot, and similar implants have been successfully used in the shoulder.
The patients will receive the same follow-up care as patients undergoing total elbow replacement and will complete patient reported outcome measures at each follow-up visit which will take place at approximately 3 weeks, 3 months, 6 months, one year and 2 years after the procedure. At each of these visits, they will have measurements of the range of elbow movement and they will undergo routine post-operative X-ray assessment at each visit as for patients undergoing total elbow replacement. Participants will also be invited to attend three sessions to look more closely at how the arm moves (biomechanics) using specialised measuring equipment, comparing them to sex-matched patients who have had a total elbow replacement. This study will aim to evaluate the outcomes and safety of this novel procedure. Criteria for early closure of the trial will include high rates of complications. The findings of the study will be published to advance this area of orthopaedic practice.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
21/NW/0231
Date of REC Opinion
20 Sep 2021
REC opinion
Further Information Favourable Opinion