New elbow procedure for advanced osteoarthritis
A Prospective Case Series to Evaluate the Outcomes and Acceptability of a Novel Surgical Technique of Pyrocarbon Interposition Arthroplasty of the Elbow, in Young Patients With Severe Arthritis.
This study is testing a new elbow procedure to see if it can help people with advanced osteoarthritis who need to keep using their arms for daily activities.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 8 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Wrightington, Wigan and Leigh NHS Foundation Trust Academic / other |
| Locations | 1 site (Wigan) |
| Trial ID | NCT05464459 on ClinicalTrials.gov |
What this trial studies
This study focuses on a novel elbow procedure aimed at patients with advanced osteoarthritis, post-traumatic arthritis, or post-septic arthritis who are not suitable for total elbow arthroplasty due to high functional demands. It is a prospective observational study that will collect data from a carefully selected cohort of consenting patients to assess the effectiveness of this intervention. The study aims to evaluate pain relief and improvement in upper limb function, which are critical for daily activities. The research is classified as a stage I study according to the IDEAL framework for surgical innovation.
Who should consider this trial
Good fit: Ideal candidates include individuals with advanced osteoarthritis or post-traumatic arthritis who are medically fit for surgery and have failed conservative treatments.
Not a fit: Patients with severe inflammatory arthritis and significant bone destruction, or those whose arthritis can be treated with arthroscopic debridement, may not benefit from this study.
Why it matters
Potential benefit: If successful, this procedure could provide significant pain relief and improved functionality for patients with advanced elbow arthritis.
How similar studies have performed: While total elbow arthroplasty has been established as an effective treatment, this specific novel approach is relatively untested, making it a potentially innovative intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Medically fit for surgery * Advanced osteoarthritis, post-traumatic arthritis, or post-septic arthritis * Severe inflammatory arthritis without severe bone destruction - Larsen grade III or less * Failed conservative treatment * Unsuitable for TEA due to high functional demands Exclusion Criteria: * Severe inflammatory arthritis with severe bone destruction * Arthritis suitable for treatment with arthroscopic debridement.
Where this trial is running
Wigan
- Wrightington, Wigan & Leigh Teaching Hospitals NHS Foundation Trust — Wigan, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Adam Watts — Wrightington, Wigan & Leigh Teaching Hospitals NHS Foundation Trust
- Study coordinator: Adam Watts
- Email: researchadmin@wwl.nhs.uk
- Phone: 01257 567204
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.