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RECRUITING
NCT04571918
NA

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

Sponsor: Oslo University Hospital

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

Biodegradable spacer

Implantation of a biodegradable balloon used as a subacromial spacer.

PROCEDURE

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