Treatment for massive rotator cuff tears using a biodegradable spacer
Arthroscopic Treatment of Massive Rotator Cuff Tears With Debridement and or Biodegradable Spacer: a Prospective Randomized Clinical Trial.
This study is testing whether using a biodegradable spacer during surgery for massive rotator cuff tears can help patients recover better than surgery without the spacer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 60 Years to 85 Years |
| Sex | All |
| Sponsor | Oslo University Hospital Academic / other |
| Locations | 2 sites (Arendal and 1 other locations) |
| Trial ID | NCT04571918 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates a new treatment approach for massive rotator cuff tears (MRCT) by comparing two surgical methods. Participants will be randomly assigned to receive either arthroscopic debridement and biceps tenotomy with a biodegradable spacer or the same procedures without the spacer. The study aims to evaluate the effectiveness of the biodegradable spacer in improving patient outcomes post-surgery. Both the physiotherapist and the patient will be blinded to the treatment group to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates are adults aged 60 to 85 suffering from symptomatic massive rotator cuff tears with documented failure of conservative treatment.
Not a fit: Patients with significant shoulder osteoarthritis or total rupture of specific tendons may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery and pain management for patients with massive rotator cuff tears.
How similar studies have performed: While there have been small non-randomized studies on this approach, this trial represents a novel and more rigorous investigation into the use of biodegradable spacers for MRCT.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients suffering from a symptomatic massive rotator cuff tear, with fatty infiltration grade 3 or 4 classified on CT by Goutallier et al, or MRI by Fuchs classification. * Persistent pain for at least 3 months, with documented failure of conservative treatment * Age ranging from 60 years of age to 85 years of age Exclusion Criteria: * Significant shoulder osteoarthritis in the affected shoulder, Hamada classification \>2. * Total rupture of subscapularis tendon and/or teres minor, classified B and E in the Collins classification. * Comorbidity to the degree that the patient will not be able to participate in the follow up program.
Where this trial is running
Arendal and 1 other locations
- Hospital of Southern Norway, Arendal — Arendal, Norway (Recruiting)
- Oslo university hospital — Oslo, Norway (Not_yet_recruiting)
Study contacts
- Study coordinator: Hannah Ugletveit Jahr, Cand. med.
- Email: hannah.jahr@gmail.com
- Phone: +47 90762377
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.