NCT04571918 Arthroscopic Treatment of Massive Rotator Cuff Tears With Debridement and Biodegradable Spacer.
| NCT ID | NCT04571918 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oslo University Hospital |
| Condition | Massive Rotator Cuff Tears |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2020-11-01 |
| Primary Completion | 2022-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2020-11-01 with a primary completion date of 2022-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Massive rotator cuff tears are common in the adult population. It is estimated that about 12 % of adults 60 years of age or older suffer from a rotator cuff injury. About 40 % of these injuries are classified as massive rotator cuff tears (MRCT). MRCT propose a great challenge to the affected patient and its doctor. It is a painful condition with few treatment options. The study aims to investigate the operative treatment for MRCT with the new treatment option proposed by Senecovic. Insertion of a biodegradable balloon as a subacromial spacer has proven promising results so far. To this date there is only small and non-randomized studies on the subject. AMRIS are planning to do a randomized controlled study where group A is treated with arthroscopic debridement, biceps tenotomy and biodegradable spacer, while group B, the control group are treated with arthroscopic debridement and biceps tenotomy.
Eligibility 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.
Contact & Investigator
Hannah Ugletveit Jahr, Cand. med
STUDY DIRECTOR
Hospital of southern Norway
Frequently Asked Questions
Who can join the NCT04571918 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, up to 85 Years, studying Massive Rotator Cuff Tears. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04571918 currently recruiting?
Yes, NCT04571918 is actively recruiting participants. Contact the research team at hannah.jahr@gmail.com for enrollment information.
Where is the NCT04571918 trial being conducted?
This trial is being conducted at Arendal, Norway, Oslo, Norway.
Who is sponsoring the NCT04571918 clinical trial?
NCT04571918 is sponsored by Oslo University Hospital. The principal investigator is Hannah Ugletveit Jahr, Cand. med at Hospital of southern Norway. The trial plans to enroll 50 participants.