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Arthroscopic Treatment of Massive Rotator Cuff Tears With Debridement and Biodegradable Spacer.
Sponsor: Oslo University Hospital
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.
Official title: Arthroscopic Treatment of Massive Rotator Cuff Tears With Debridement and or Biodegradable Spacer: a Prospective Randomized Clinical Trial.
Key Details
Gender
All
Age Range
60 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2020-11-01
Completion Date
2029-09-01
Last Updated
2020-10-01
Healthy Volunteers
No
Conditions
Interventions
Biodegradable spacer
Implantation of a biodegradable balloon used as a subacromial spacer.
Debridement and biceps tenotomy
Surgery with arthroscopic debridement and biceps tenotomy
Locations (2)
Hospital of Southern Norway, Arendal
Arendal, Norway
Oslo university hospital
Oslo, Norway