Arthroscopic Superior Capsular Reconstruction - Study of Different Types of Grafts

Study Overview
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Brief Summary
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Multicentric prospective clinical and radiological comparative study of consecutive patients with irreparable rotator cuff tears to test the hypothesis that there are significant differences in the improvement of the clinical and imaging outcomes of arthroscopic superior capsular reconstruction (ASCR) when a different type of graft is used.

Detailed Description
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Patients with irreparable rotator cuff tears who meet the eligibility criteria will be enrolled in the study and undergo arthroscopic superior capsular reconstruction using one of the following types of graft: fascia lata autograft, fascia lata allograft, Achilles tendon allograft, bovine pericardium xenograft, swine dermal xenograft, or collagen graft. All patients will be assessed clinically, radiologically and with an MRI preoperatively and at the 6-months and at the 2-years postoperative evaluations. The range of motion (ROM), shoulder abduction strength, Constant (CS), simple shoulder test (SST) and subjective shoulder value (SSV) scores will be compared from preoperative to 6 months postoperative; from 6 months postoperative to 2 years postoperative (paired-samples t-test, two-tailed) in each group (allotment to groups is performed according to the type of graft used: fascia lata autograft, fascia lata allograft, Achilles tendon allograft, bovine pericardium xenograft, swine dermal xenograft, or collagen graft). The differences in ROM, shoulder abduction strength, CS, SST and SSV scores from preoperative to 6 months postoperative and from 6 months postoperative to 2 years postoperative will be compared between groups. All continuous variables will be compared between the group of patients with graft tears and the group without graft tears (Mann-Whitney U test). All categorical variables and outcome results will be compared between groups (Fisher's exact test). A significant difference will be defined as P<0.05.

Official Title
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Arthroscopic Superior Capsular Reconstruction - Multicentric Prospective Comparative Study of Different Types of Grafts

Conditions
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Rotator Cuff Tear, Graft Complication

Intervention / Treatment
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* Procedure: Arthroscopic superior capsular reconstruction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Rotator cuff tear arthropathy, Hamada stage 1 or 2 Complete rotator cuff tendon tear involving one or more tendons, with a Patte stage 3 tendon retraction on the preoperative magnetic resonance imaging Exclusion Criteria: Rotator cuff tear arthropathy, Hamada stage 3 or 4 Complete rotator cuff tendon tear involving one or more tendons, with Patte stage 1 or 2 tendon retraction on the preoperative magnetic resonance imaging Proximal humerus fracture Acute shoulder dislocation (in the previous 8 weeks)

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 100 Years

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: Multiple group assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fascia lata autograft<br>Arthroscopic superior capsular reconstruction using a fascia lata autograft | Procedure: Arthroscopic superior capsular reconstruction<br>* The superior capsule of patients with irreparable rotator cuff tears will be reconstructed using an autograft or an allograft<br>|
| Active Comparator: Fascia lata allograft<br>Arthroscopic superior capsular reconstruction using a fascia lata allograft | Procedure: Arthroscopic superior capsular reconstruction<br>* The superior capsule of patients with irreparable rotator cuff tears will be reconstructed using an autograft or an allograft<br>|
| Active Comparator: Achilles tendon allograft<br>Arthroscopic superior capsular reconstruction using an achilles tendon allograft | Procedure: Arthroscopic superior capsular reconstruction<br>* The superior capsule of patients with irreparable rotator cuff tears will be reconstructed using an autograft or an allograft<br>|
| Active Comparator: Bovine pericardium allograft<br>Arthroscopic superior capsular reconstruction using a bovine pericardium allograft | Procedure: Arthroscopic superior capsular reconstruction<br>* The superior capsule of patients with irreparable rotator cuff tears will be reconstructed using an autograft or an allograft<br>|
| Active Comparator: Swine dermal xenograft<br>Arthroscopic superior capsular reconstruction using a swine dermal xenograft | Procedure: Arthroscopic superior capsular reconstruction<br>* The superior capsule of patients with irreparable rotator cuff tears will be reconstructed using an autograft or an allograft<br>|
| Active Comparator: Collagen allograft<br>Arthroscopic superior capsular reconstruction using a collagen allograft | Procedure: Arthroscopic superior capsular reconstruction<br>* The superior capsule of patients with irreparable rotator cuff tears will be reconstructed using an autograft or an allograft<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constant score | Constant score at 2 years postoperatively (minimum 1 point - maximum 100 points); For the scale range provided, higher values represent a better outcome | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft integrity on the magnetic resonance imaging | Graft integrity on the 2-year postoperative magnetic resonance imaging (scale: 0 -1): 0 = graft absent or not healed to the greater tuberosity/superior glenoid; 1 = graft present and healed to the greater tuberosity and superior glenoid. For the scale range provided, higher values represent a better outcome. | 2 years | 
| Shoulder active range of motion | Shoulder active range of motion (ROM) at 2 years postoperatively measured in degrees using an analogic goniometer: elevation (0 - 180º), abduction (0 - 180º) and external rotation (0 - 100º); and internal rotation, defined as the highest vertebral body that the patient's thumb can reach, converted afterwards to a scale of 1 - 5 points: lateral thigh=0; buttock=1; sacrum=2; lumbar=3; 12th thoracic vertebra=4; 7th thoracic vertebra=5. For the scale range provided, higher values represent a better outcome. | 2 years | 
| Simple shoulder test | Simple shoulder test ((minimum 1 point - maximum 12 points) at 2 years postoperatively. For the scale range provided, higher values represent a better outcome. | 2 years | 
| Acromiohumeral interval | True anteroposterior shoulder radiograph at 2 years postoperatively: the acromiohumeral interval (AHI), considering the distance between the top of the humeral head and the undersurface of the acromion, measured using a software measurement tool (PACS, Agfa HealthCare); the RCT arthritis will be graded according to the Hamada revised radiographic classification. For the scale range provided, higher values represent a better outcome. | 2 years | 
| Shoulder strength | Shoulder strength at 2 years postoperatively measured in kilograms using a digital dynamometer: supraspinatus (0 - 25 kg).For the scale range provided, higher values represent a better outcome. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthroscopic Superior Capsular Reconstruction, Irreparable rotator cuff tear, Allograft, Autograft, Xenograft