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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Massive Rotator Cuff Tears, Rotator Cuff Injuries, Shoulder Pain Chronic

Intervention / Treatment
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* Procedure: Arthroscopic partial repair of massive rotator cuff tear
* Procedure: Arthroscopic partial repair of rotator cuff with biceps augmentation


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2 different groups. Differences in type of surgery Comparison of two ways of treatment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment with biceps augmentation<br>Complete repair of ISP if possible with partial SSP repair and biceps augmentation after its tenodesis | Procedure: Arthroscopic partial repair of rotator cuff with biceps augmentation<br>* 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<br>|
| Active Comparator: Treatment without biceps augmentation<br>Complete repair of ISP if possible with partial SSP repair and biceps tenotomy | Procedure: Arthroscopic partial repair of massive rotator cuff tear<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of improvement in shoulder range of motion | Range of motion ( ROM) of every patient is measured preoperatively and postoperatively using goniometer and the result is presented in degrees. Comparision of two methods will be perform to assess better method for ROM improvement | Through study completion, an average of 2.5 years | 
| Comparison of improvement in shoulder strength | Strength will be measured by dynamometer in Kilograms [Kg] by main investigator in external rotation position, flexion, abduction and Jobe test position for every patient at the end of the study. Comparison of two methods will be perform to assess better method for shoulder strength improvement | Through study completion, an average of 2.5 years | 
| Comparison of improvement in shoulder pain in VAS score | Pain is assessed preoperatively and postoperatively using VAS score ( from 0 to 10, when 0 is no pain and 10 is the higher possible pain). Comparison of two methods will be perform to assess better method for shoulder pain reduce. | Through study completion, an average of 2.5 years | 
| Comparison of shoulder function measured in Constant-Murley Score | Function of the shoulder will be assess by Constant Murlay score which describes shoulder function in daily routines: In this score range is 0-100 when 100 is the best result. | Through study completion, an average of 2.5 years | 
| Comparison of shoulder function measured in SST Score | Function of the shoulder will be assess by SST score which describes shoulder function in daily routines: In this score range is 0-100% when 100% is the best result. | Through study completion, an average of 2.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of radiological outcome in Hamada score | Radiological outcome will be assessed by Hamada score. This score measure shoulder cuff arthropathy ( stage 1-5 when 1 is the best result). For every patient this score will be calculated through study completion and comparison of two methods will be performed. | Through study completion, an average of 2.5 years | 
| Comparison of radiological outcome in Sugaya score | Radiological outcome will be assessed by Sugaya score. This score is used to measure quality of tendon reconstruction in MRI view. Range of points in this score is 1-5 when 1 is the best result. For every patient this score will be calculated through study completion and comparison of two methods will be performed. | Through study completion, an average of 2.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Massive rotator cuff, Partial repair, biceps augmentation, shoulder arthroscopy