Actively Recruiting
Arthroscopic Treatment of Massive Rotator Cuff Tears With Debridement and Biodegradable Spacer.
Led by Oslo University Hospital · Updated on 2020-10-01
50
Participants Needed
2
Research Sites
460 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Arthroscopic Treatment of Massive Rotator Cuff Tears With Debridement and Biodegradable Spacer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Hospital of Southern Norway, Arendal
Arendal, Norway, 4848
Actively Recruiting
2
Oslo university hospital
Oslo, Norway, 0424
Not Yet Recruiting
Research Team
H
Hannah Ugletveit Jahr, Cand. med.
CONTACT
B
Berte Bøe, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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