Debridement vs debridement and biodegradable balloon

Authors
Category Primary study
Registry of TrialsNetherlands Trial Register
Year 2018
INTERVENTION: Group 1 Arthroscopic debridement Group 2 Arthroscopic debridement with implantation of a bio‐absorbable Balloon CONDITION: Shoulder debridement , Rotator cuff tear, Biodegradable balloon ; ; PRIMARY OUTCOME: Is there a minimal clinical difference (NRS >2) in pain levels between subjects receiving an arthroscopic debridement with a subacromial bio‐absorbable Balloon and solely arthroscopic debridement in subjects with symptomatic irreparable cuff tears after 1 year. SECONDARY OUTCOME: • Is the progress of pain and functional outcome different and clinically relevant between the two study groups over the period of 1 year? ; ; • What is the percentage of subject satisfaction after 1 year in the two study groups. ; ; • What is the percentage and type of complications after 1 year? ; ; • To compare survival rates (with endpoint reversed shoulder prosthesis) between both groups after 5 years. ; ; • What is the percentage of developing osteoarthritis in the two study groups after 2 years? ; ; • What is the position of the balloon after 10 weeks and 6 months and at what point does it loose its volume due to leakage. ; INCLUSION CRITERIA: • Subject has an irreparable supra‐ and infraspinatus tendon tear confirmed by ultrasound or MRI and is according to the Orthopaedic Surgeon a suitable candidate for debridement. • The symptoms of the subjects are existing for at least twelve months, despite conservative treatment, including physiotherapy, subacromial infiltration with corticosteroids or anti‐inflammatory drugs. • Subjects are older than 18 years.
Epistemonikos ID: 137818dd43c05eec0fbf1e4557de3ba33f4eb65f
First added on: Aug 24, 2024