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

Saint Lucas Hospital, Poland

Status: Enrolling

Conditions: Shoulder Pain Chronic; Massive Rotator Cuff Tears; Rotator Cuff Injuries

Treatments: Procedure: Arthroscopic partial repair of massive rotator cuff tear; Procedure: Arthroscopic partial repair of rotator cuff with biceps augmentation

Study type: Interventional

Funder types: Other

Identifiers

NCT05001581

SLukasH

Details and patient eligibility

About

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.

Full 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

Enrollment: 90 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

Massive and irreparable rotator cuff tear:

• chronic supraspinatus tear with retraction grade 3 and muscle fatty infiltration ( measured in MRI ) > 3*
• Infraspinatus tear with retraction and fatty muscle degeneration

Exclusion criteria

• Previosus surgery
• Imposibility to performed MRI
• Diabetes
• no compliance

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Treatment with biceps augmentation

Active Comparator group

Description:

Complete repair of ISP if possible with partial SSP repair and biceps augmentation after its tenodesis

Treatment:

Procedure: Arthroscopic partial repair of rotator cuff with biceps augmentation

Treatment without biceps augmentation

Active Comparator group

Description:

Complete repair of ISP if possible with partial SSP repair and biceps tenotomy

Treatment:

Procedure: Arthroscopic partial repair of massive rotator cuff tear