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

Last updated: October 25, 2022
Sponsor: Saint Lucas Hospital, Poland
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05001581
SLukasH
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

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

Study Design

Total Participants: 90
Study Start date:
January 30, 2019
Estimated Completion Date:
February 20, 2023

Study 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

Connect with a study center

  • Laprus

    Bielsko-Biala, Śląskie 43-309
    Poland

    Active - Recruiting

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