Outcomes of Massive Rotator Cuff Tendon Tear Treatment.

Sponsor
Tartu University Hospital
Study ID
NCT06016439
Status
Not Yet Recruiting

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Conditions

  • Rotator Cuff Syndrome
  • Rotator Cuff Tears

Eligibility Criteria

Sex
ALL
Age
50 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Arthroscopic rotator cuff partial repair with superior capsular augmentation with LHBBT — PROCEDURE
    Residual rotator cuff defect will be reconstructed using LHBBT.
  • Arthroscopic rotator cuff partial repair — PROCEDURE
    Rotator cuff will be repaired with remaining residual defect.
  • Arthroscopic complete rotator cuff repair — PROCEDURE
    Arthroscopic complete repair as a standard procedure.
  • Suture anchor(s) — DEVICE
    Arthroscopic rotator cuff tendon(s) repair using suture anchor(s).

Study Details

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.

Key Dates

First listed
Aug 29, 2023
Start date
Jan 31, 2024
Status verified
Nov 2023
Primary completion
Dec 31, 2033
Completion
Dec 31, 2033

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arthroscopic rotator cuff partial repair with superior capsule augmentation with LHBBT
    If a tear is intra-operatively determined irreparable, randomization takes place. Irreparable tears that are randomly selected to receive arthroscopic rotator cuff partial repair including superior capsular augmentation with proximal part of the long head of the biceps tendon. The long head of the biceps tendon will be released from bicipital groove and proximal part of the tendon will be used to cover the rotator cuff gap and anchored to the greater tuberosity.
  • Active Comparator: Arthroscopic partial rotator cuff repair
    If a tear is intra-operatively determined irreparable, randomization takes place. Irreparable tears that are randomly selected to receive arthroscopic partial repair.
  • Other: Arthroscopic rotator cuff repair
    Arthroscopic complete repair.
  • No Intervention: Rotator cuff tear conservative treatment
    Conservative treatment following physiotherapy protocol.

Primary Outcome Measure

Change in shoulder strength [ Time Frame: Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit ]

Central Contacts

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