Outcomes of Massive Rotator Cuff Tendon Tear Treatment.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorTartu University Hospital

About this trial

Rotator cuff tear is the leading cause of shoulder pain in the elderly. There isn't enough evidence nor clinical guidelines to guide the treatment of massive rotator cuff tears, specially irreparable tears. Arthroscopic partial repair has been widely used and superior capsular reconstruction (SCR), either with allograft, autograft or augmentation with long head biceps brachii tendon (LHBBT), has been recently added. It is showing promising results, but lacking high quality evidence.

This is a prospective clinical study to compare the outcomes of different surgical methods for massive rotator cuff tendon tears. Minimal follow-up time will be two years. In this trial, massive rotator cuff tears will be anatomically repaired if possible. For irreparable tears a method will be randomly assigned intra-operatively once a tear is determined to be irreparable - either partial repair or partial repair with superior capsular reconstruction using the long head biceps brachii (LHBB) tendon. Patients who are eligible for the study but refuse operative treatment, will serve as conservative study group.

The hypothesis is that massive rotator cuff tears that are reparable will have the best functional outcomes. For irreparable tears, augmentation with LHBBT will give superior results over partial repair.

Eligibility criteria

Qualifiers

Massive rotator cuff tendon tear: grade III according to Davidson and Burkhart 2010 classification, diagnosed on MRI, and LHBB tendon is intact.

Primary rotator cuff pathology AND

Symptoms have not lasted more than 6 months.

In case of trauma, traumatic event no more than 6 months ago.

Disqualifiers

Previous rotator cuff surgery of the index shoulder.

Acute or chronic osteomyelitis.

Inflammatory joint disease (rheumatoid arthritis/ (pseudo)gout arthritis).

Uncontrolled diabetes.

Trial design

Treatments tested in this trial

  • Arthroscopic rotator cuff partial repair with superior capsular augmentation with LHBBT
  • Arthroscopic rotator cuff partial repair
  • Arthroscopic complete rotator cuff repair
  • Suture anchor(s)

Treatment groups

80 Participants
are divided into 4 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Tartu University Hospital

Lead sponsor

University of Tartu

Collaborator