NCT05001581

Irreparable Rotator Cuff Tears Treatment. Comparison of Two Methods: With and Without Biceps Tendon Augmentation

Massive and Irreparable Rotator Cuff Tears Treated by Arthroscopic Partial Repair and Partial Repair With Long Head of the Biceps Tendon Augmentation. Comparison of Clinical and Radiological Findings

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Saint Lucas Hospital, Poland · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Management of massive rotator cuff tears (MRCT) is associated with high rates of failure. The long head of the biceps tendon augmentation (LHBTA) by reinforcement of the reconstruction and additional blood supply may improve healing and provide better outcome than partial repair only.

Detailed description

Patients with irreparable supraspinatus muscle (SSP) tear, and complete infraspinatus muscle (ISP) tear are including in the prospective, comparative study. Excluding criteria consist of: problems or previous surgery of contralateral shoulder, subscapularis muscle tear larger than stage 2 by Lafosse classification, uncontrolled diabetes and previous surgery. First group consisting of patients treated by partial cuff repair with LHBTA. Second group is comparative group consisting of patients treated by only partial cuff repair without LHBTA. Group stratification depends on quality of the biceps tendon. In case of good tendon quality - its used for biological augmentation, if it's degenerated- tenotomy of the tendon and only partial repair is performing. Irreparability is defined as SSP ≥ 3 in Goutallier classification and stage 3 in Patte classification what is preoperatively assessed by MRI. Assessment tools consisting of range of motion (ROM), strength measurements in position adequate to assess reconstructing tendons and muscles force, Acromio-humeral index (AHI), Constant, SST, Hamada, and Sugaya scores. Goutallier classification for SSP and ISP and diameter of the teres minor muscle (TMn). Radiological and clinical assessment is performing one year after the surgery

Conditions

• Massive Rotator Cuff Tears
• Rotator Cuff Injuries
• Shoulder Pain Chronic

Interventions

Type	Name	Description
PROCEDURE	Arthroscopic partial repair of massive rotator cuff tear	Surgery relies on arthroscopic reconstruction of the rotator cuff tendons. Because of irreparability of Supraspinatus tendon ( always) and infraspinatus tendon ( sometimes) surgeon performed partial repair to cover humeral head by the tendons
PROCEDURE	Arthroscopic partial repair of rotator cuff with biceps augmentation	Surgery relies on arthroscopic reconstruction of the rotator cuff tendons. Because of irreparability of Supraspinatus tendon ( always) and infraspinatus tendon ( sometimes) surgeon performed partial repair to cover humeral head by the tendons and because of good quality of the long head of the biceps tendon, its uses as biological reinforcement of the reconstruction to achieve better clinical and radiological outcome

Timeline

• Start date: 2019-01-30
• Primary completion: 2023-01-01
• Completion: 2023-02-20
• First posted: 2021-08-12
• Last updated: 2022-10-27

Locations

1 site across 1 country: Poland