Arthroscopic Surgical Outcome Study In Subjects With Rotator Cuff Tears

Study Overview
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Brief Summary
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This is an observational study that involves subjects with full-thickness rotator cuff tears treated by means of arthroscopy surgical repair, also known as arthroscopic surgery. The primary objective of this study is to observe the timing and rate of tendon retear in those subjects.

Detailed Description
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Subjects will be recruited from each surgeon's surgical practice. They will be reviewed to assure they meet all eligibility criteria prior to enrolling them into the study.

Official Title
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A PROSPECTIVE STUDY TO EVALUATE SURGICAL OUTCOMES IN SUBJECTS WITH FULL-THICKNESS ROTATOR CUFF TEARS TREATED BY MEANS OF A DOUBLE-ROW ARTHROSCOPIC REPAIR.

Conditions
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Rotator Cuff, Arthroscopic Surgery

Intervention / Treatment
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* Other: Observational study of the surgical outcome


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Full thickness Rotator Cuff Tears ranging from 1cm to 4cm in size. Planned procedure for repair is tendon-to-bone repair by means of an arthroscopy Exclusion Criteria: Previous surgical intervention to the shoulder joint understudy Tears of the subscapularis or labral pathology requiring surgical repair Shoulder instability either shoulder Unable to complete functional evaluations in either shoulder

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Standard of Care | Other: Observational study of the surgical outcome<br>* Subjects return for 7 follow-up visits following arthroscopic repair of their rotator cuff. During the follow-up visits subjects undergo imaging with MRI and ultrasound.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective is to observe the rate and timing of tendon retear in subjects with full thickness rotator cuff tears (RCTs) treated by means of arthroscopic surgery. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the correlation of functional outcomes over time in subjects with retears compared with subjects who have an intact cuff repair using the Constant Murley Shoulder Score as well as strength and range of motion. |  | 1 year | 
| Determination of the correlation between imaging biomarkers (muscle atrophy and fatty infiltration) and the subjects outcome (retear and function). |  | 1 year | 
| Estimation of the relationship between patient reported outcomes and subject's surgical and functional outcomes. |  | 1 year | 
| Evaluation of the ability to define |  | 1 year | 
| Observation of any comorbidity associated with the arthroscopic surgical procedure through the collection of adverse events to provide and SOC reference for future safety studies. |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Observational, rotator cuff tear, arthroscopic, surgical, outcome study