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

NCT04571918 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-10-01

No results posted yet for this study

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.

Conditions

  • Massive Rotator Cuff Tears

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

Sponsors & Collaborators

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Hannah Ugletveit Jahr, Cand. med · Hospital of southern Norway

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2022-09-01
Completion
2029-09-01

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04571918 on ClinicalTrials.gov