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Arthroscopic Treatment of Massive Rotator Cuff Tears With Debridement and Biodegradable Spacer.

RecruitingNAAges 60 Years - 85 YearsAllOslo University Hospital
NCT04571918 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 bicep

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📋 Eligibility rules (as published)
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.
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What it tests

  • Biodegradable spacer
  • Debridement and biceps tenotomy
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Where

2 sites
Hospital of Southern Norway, Arendal
Arendal, Norway
Oslo university hospital
Oslo, Norway
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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