Pilot Study to Evaluate the Restore Orthobiologic Implant in Rotator Cuff Tear Repair

Study Overview
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Brief Summary
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Primary Endpoints: Comparative evaluation of any differences between the two groups in change from baseline to the 3-month time point in terms of: Functional recovery (patient-based) - using the Oxford Shoulder Score. Functional recovery and early return of strength (pain, activities of daily living [ADL], range of motion [ROM], and power) - evaluated using the Constant Shoulder Assessment. Functional recovery (pain and function - patient-based), evaluated using the American Shoulder and Elbow Surgeons (ASES) Shoulder Assessment - patient self-report section. Region-specific Quality of Life - using the Western Ontario Rotator Cuff (WORC) Index. Range of motion - assessed by goniometer recorded as part of the Constant Score. Pain (taken from Pain visual analog scale [VAS] of the ASES Shoulder Assessment); and Record of escape pain medication usage (recorded in a daily patient diary). Secondary Endpoints: Comparative evaluation of any difference between the two groups in change from baseline to the 6-week time point, in terms of: Pain (taken from Pain VAS of the ASES Shoulder Assessment) and record of escape pain medication usage (recorded in a daily patient diary). Comparative evaluation of any differences between the two groups in change from baseline to the 6-month time point, in terms of: Functional recovery (patient-based) - using the Oxford Shoulder Score. Functional recovery and early return of strength (pain, ADL, ROM, and power) - evaluated using the Constant Shoulder Assessment. Functional recovery (pain and function - patient-based), evaluated using the ASES Shoulder Assessment - patient self-report section. Region-specific Quality of Life - using the Western Ontario Rotator Cuff Index. Range of motion - assessed by goniometer recorded as part of the Constant Score. Pain (taken from Pain VAS of the ASES Shoulder Assessment) and record of escape pain medication usage (recorded in a patient diary). Comparative evaluation of any difference between the two groups in change from baseline to the 6-week, 3, 6 and 12 month time points, in terms of health status - assessed by the EQ-5D instrument.

Official Title
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A Prospective, Randomised Pilot Study to Determine the Variability of Early Clinical Outcome in Subjects Undergoing Full Thickness Rotator Cuff Tear Repair, When Augmented With or Without Porcine Small Intestine Submucosa (RESTORE)

Conditions
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Arm Injuries

Intervention / Treatment
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* Device: RESTORE SIS Patch
* Procedure: Rotator cuff repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects, aged 40 and above. Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained. Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures, and are willing to return to the hospital for all the required post-operative follow-ups. Subjects whose clinical symptoms and diagnosis suggest that they have a full-thickness rotator cuff tear (which includes but is not limited to the supraspinatus), which is degenerate in nature. Exclusion Criteria: Subjects who, in the opinion of the Investigator, have an existing condition that would prevent them from fulfilling the requirements of the Clinical Investigation Plan. (This should be detailed in the Screening Log.) Women who are pregnant. Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes. Subjects who have participated in a clinical study with an investigational product in the last 6 months. Subjects who are currently known to be involved in any injury litigation claims relating to the shoulder being treated as part of the study. Subjects with a known allergy to porcine material or who, for religious or other reasons, are unwilling to accept a porcine-derived implant. Subjects who have undergone previous shoulder surgery (excluding purely-diagnostic arthroscopy). Subjects with significant paralysis of the shoulder. Subjects with inflammatory arthropathies. Subjects with active joint or systemic infection.

Ages Eligible for Study
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Minimum Age: 40 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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Rotator cuff repair with RESTORE Porcine Small Intestine Submucosa patch (RESTORE SIS Patch) reinforcement | Device: RESTORE SIS Patch<br>* Surgical repair of torn rotator cuff with RESTORE Porcine Small Intestine Submucosa patch (RESTORE SIS Patch) reinforcement<br>|
| Active Comparator: 2<br>Standard rotator cuff repair | Procedure: Rotator cuff repair<br>* Standard surgical repair of torn rotator cuff<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference demonstrated between two groups on the Oxford Shoulder Score from baseline to 3 months |  | 3 months | 
| Difference demonstrated between two groups on the Constant Shoulder Assessment from baseline to 3 months |  | 3 months | 
| Difference demonstrated between two groups on the ASES Shoulder Assessment from baseline to 3 months |  | 3 months | 
| Difference demonstrated between two groups on the Western Ontario Rotator Cuff Index from baseline to 3 months |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference demonstrated between the two groups on the ASES Shoulder Assessment from baseline to 6 weeks. |  | 6 weeks | 
| Difference demonstrated between the two groups on the ASES Shoulder Assessment from baseline to 6 months |  | 6 months | 
| Difference demonstrated between 2 groups on EQ-5D from baseline to 6 weeks |  | 6 weeks | 
| Difference demonstrated between the two groups on the Constant Shoulder Assessment from baseline to 6 months |  | 6 months | 
| Difference demonstrated between the two groups on the Oxford Shoulder Score from baseline to 6 months |  | 6 months | 
| Difference demonstrated between the two groups on the Western Ontario Rotator Cuff from baseline to 6 months |  | 6 months | 
| Difference demonstrated between 2 groups on EQ-5D from baseline to 3 months |  | 3 months | 
| Difference demonstrated between 2 groups on EQ-5D from baseline to 6 months |  | 6 months | 
| Difference demonstrated between 2 groups on EQ-5D from baseline to 12 months |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rotator cuff tear repair