Treatment for massive rotator cuff tears using a biodegradable spacer
Official title: Arthroscopic Treatment of Massive Rotator Cuff Tears With Debridement and or Biodegradable Spacer: a Prospective Randomized Clinical Trial.
Run by Oslo University Hospital · NCT04571918 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 60 Years to 85 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Oslo University Hospital Academic / other |
| Locations | 2 sites (Arendal and 1 other locations) |
| Status | Recruiting |
| Started | November 1, 2020 |
| Main results expected | September 1, 2022 |
| Study ends | September 1, 2029 |
| Registry record updated | October 1, 2020 |
| Trial ID | NCT04571918 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 60 to 85 suffering from symptomatic massive rotator cuff tears with documented failure of conservative treatment.
✕Probably not a fit
Patients with significant shoulder osteoarthritis or total rupture of specific tendons may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.