Clinical trial NCT05001581: Irreparable Rotator Cuff Tears Treatment. Comparison of Two Methods: With and Without Biceps Tendon Augmentation
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Massive Rotator Cuff Tears
Rotator Cuff Injuries
Shoulder Pain Chronic
Keywords: Massive rotator cuff
Partial repair
biceps augmentation
shoulder arthroscopy
Lead sponsor: Saint Lucas Hospital, Poland
Sponsor class: OTHER
First posted: 2021-08-12
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 different groups. Differences in type of surgery Comparison of two ways of treatment
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of improvement in shoulder range of motion
timeFrame: Through study completion, an average of 2.5 years
measure: Comparison of improvement in shoulder strength
timeFrame: Through study completion, an average of 2.5 years
measure: Comparison of improvement in shoulder pain in VAS score
timeFrame: Through study completion, an average of 2.5 years
measure: Comparison of shoulder function measured in Constant-Murley Score
timeFrame: Through study completion, an average of 2.5 years
measure: Comparison of shoulder function measured in SST Score
timeFrame: Through study completion, an average of 2.5 years
Secondary outcomes:
measure: Comparison of radiological outcome in Hamada score
timeFrame: Through study completion, an average of 2.5 years
measure: Comparison of radiological outcome in Sugaya score
timeFrame: Through study completion, an average of 2.5 years
Other outcomes:
Locations:
city: Bielsko-Biala
country: Poland
facility: Laprus
state: Śląskie
Study officials:
affiliation: St Lukes's Hospital
name: Roman Brzoska, Ph.D, MD
role: STUDY_CHAIR
References: