Outcomes of Massive Rotator Cuff Tendon Tear Treatment.

Summary

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.

Conditions

• Rotator Cuff Tears
• Rotator Cuff Syndrome

Interventions

PROCEDURE

Arthroscopic rotator cuff partial repair with superior capsular augmentation with LHBBT

Residual rotator cuff defect will be reconstructed using LHBBT.

PROCEDURE

Arthroscopic rotator cuff partial repair

Rotator cuff will be repaired with remaining residual defect.

PROCEDURE

Arthroscopic complete rotator cuff repair

Arthroscopic complete repair as a standard procedure.

DEVICE

Suture anchor(s)

Arthroscopic rotator cuff tendon(s) repair using suture anchor(s).

Sponsors & Collaborators

• University of Tartu

  collaborator OTHER

• Tartu University Hospital

  lead OTHER

Principal Investigators

• Tiina Tikk, MD · University of Tartu

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-31

Primary Completion

2033-12-31

Completion

2033-12-31