NCT06016439

Outcomes of Massive Rotator Cuff Tendon Tear Treatment.

Outcomes of Different Treatment Modalities for Massive Rotator Cuff Tendon Tear.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Tartu University Hospital · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients with massive rotator cuff tendon tears aged between 50 to 80 years will be included in the study following the eligibility criteria. Massive tear is defined as grade III tear according to Davidson and Burkhart classification (2010), supraspinatus (SSP) tendon retraction described by Patte (1990) classification. The study is conducted in Tartu University Hospital Sports Traumatology Centre and rotator cuff repair procedures will be done by three orthopaedic surgeons with long experience in arthroscopic shoulder surgery. It is determined intra-operatively whether the tear is reparable or not. If possible, the tendon(s) will be anatomically repaired. For irreparable tears intra-operative urn randomization takes place - either partial repair or partial repair with SCR using the LHBB tendon. Surgical techniques will be standardized. Patients who refuse operative treatment, will be followed as conservative treatment group. The primary objective of the study is the functional status of the included subjects in different treatment groups. The secondary objective of the study is to confirm whether the tendons are intact on follow-up magnetic resonance imaging (MRI) 6 months, 12 months and 24 months after operation using Sugaya classification (2007). The post-operative therapy regimen will be the same for each study group. Subjects will come for scheduled visits at 6-month, 12-month, and 24-month timepoints. Assessment tools consist of range of motion (ROM), strength measurements, preoperative radiography measuring acromio-humeral index (AHI), critical shoulder angle (CSA), acromion type and shoulder arthrosis (Hamada), functional scores: The Disabilities of the Arm, Shoulder and Hand (DASH), The Constant-Murley score (CMS), The American Shoulder and Elbow Surgeons (ASES) and visual analogue scale (VAS), also including Tampa kinesiophobia score and emotional well-being (EEK) score. Goutallier classification (1994) will be used pre- and postoperatively to measure muscle fatty infiltration.

Conditions

• Rotator Cuff Tears
• Rotator Cuff Syndrome

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2024-01-01
• Primary completion: 2033-12-01
• Completion: 2033-12-01
• First posted: 2023-08-29
• Last updated: 2023-11-24