Arthroscopic Treatment of Massive Rotator Cuff Tears With Debridement and Biodegradable Spacer.
Arthroscopic Treatment of Massive Rotator Cuff Tears With Debridement and or Biodegradable Spacer: a Prospective Randomized Clinical Trial.
Oslo University Hospital
50 participants
Nov 1, 2020
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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 Criteria3
- 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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Interventions
Implantation of a biodegradable balloon used as a subacromial spacer.
Surgery with arthroscopic debridement and biceps tenotomy
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT04571918