Evaluation of a new joint replacement system for various conditions
Comprehensive Segmental Revision System
This study is testing a new joint replacement system for shoulders and elbows to see how well it works for people with joint problems over the next ten years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 105 (estimated) |
| Sex | All |
| Sponsor | Zimmer Biomet Industry-sponsored |
| Locations | 4 sites (Halifax, Nova Scotia and 3 other locations) |
| Trial ID | NCT03270982 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the performance and clinical outcomes of the Comprehensive Segmental Revision System, which includes prosthetic replacements for the shoulder and elbow. The study will gather clinical data over a period of at least ten years, using established measurement tools like the quickDASH and other specific scores for shoulder, elbow, and oncology applications. The data collected will inform design improvements, marketing strategies, and reimbursement discussions for the device. The study population will include both males and females who meet specific inclusion criteria related to degenerative joint diseases and other conditions.
Who should consider this trial
Good fit: Ideal candidates include individuals with non-inflammatory degenerative joint diseases, rheumatoid arthritis, or those needing revision surgery after previous devices have failed.
Not a fit: Patients with active infections or sepsis will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes for patients requiring joint replacements after previous failures.
How similar studies have performed: Other studies have shown success with similar joint replacement systems, indicating potential for positive outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Non Inflammatory Degenerative joint disease, including osteoarthritis, and avascular necrosis * Rheumatoid arthritis * Revision where other devices or treatments have failed * Correction of functional deformity * Oncology applications including bone loss due to tumour resection Exclusion Criteria: * Sepsis ( active) * Infection ( active) * Osteomyelitis (active)
Where this trial is running
Halifax, Nova Scotia and 3 other locations
- Nova Scotia Health Authority — Halifax, Nova Scotia, Canada (Recruiting)
- Department of Orthopedic Surgery, Rigshospitalet University of Copenhagen — Copenhagen, Denmark (Recruiting)
- Royal Gwent Hospital — Newport, Wales, United Kingdom (Completed)
- Royal Liverpool University Hospital — Liverpool, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Carina Hafner
- Email: carina.hafner@zimmerbiomet.com
- Phone: +41 79 707 30 93
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.