Arthroscopic Surgical Outcome Study In Subjects With Rotator Cuff Tears

Completed

• Conditions: Rotator Cuff; Arthroscopic Surgery
• Interventions: Other: Observational study of the surgical outcome

• Registration Number: NCT00739947
• Lead Sponsor: Pfizer

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2008-08-21
• Study First Submitted QC: 2008-08-21
• Study First Posted: 2008-08-22
• Study Start: 2008-10-13
• Primary Completion: 2011-07-05
• Study Completion: 2011-07-05
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-12
• Last Update Posted: 2021-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Observational study of the surgical outcome	Standard of Care

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
Evaluation of the ability to define	1 year

Trial Locations

Locations (29)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

The Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

The Core Institute; 🇺🇸 Sun City, Arizona, United States

Paradise Valley Hospital; 🇺🇸 Phoenix, Arizona, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

Kelsey Research Foundation; 🇺🇸 Houston, Texas, United States

Kelsey-Seybold Spring Medical and Diagnostic Center; 🇺🇸 Houston, Texas, United States

St. Luke's Episcopal Hospital; 🇺🇸 Houston, Texas, United States

Massachusetts General Hospital; 🇺🇸 Waltham, Massachusetts, United States

University Orthopedics, Inc.; 🇺🇸 Providence, Rhode Island, United States

Harris Methodist Southlake; 🇺🇸 Southlake, Texas, United States

The Everett Clinic; 🇺🇸 Everett, Washington, United States

University Orthopedics; 🇺🇸 Providence, Rhode Island, United States

Hospital for Special Surgery; 🇺🇸 New York, New York, United States

Yale-New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States

Texas Orthopedic Specialists, PA; 🇺🇸 Bedford, Texas, United States

University Orthopaedic Associates; 🇺🇸 Rochester, New York, United States

Mount Sinai Medical Center; 🇺🇸 New York, New York, United States

Preferred Imaging; 🇺🇸 Grapevine, Texas, United States

Orthopedic Specialists; 🇺🇸 Grapevine, Texas, United States

Desert Valley Radiology; 🇺🇸 Phoenix, Arizona, United States

Kelsey Seybold Clinic; 🇺🇸 Houston, Texas, United States

Banner Del E Webb Medical Center; 🇺🇸 Sun City West, Arizona, United States

The CORE Institute-Sun City West; 🇺🇸 Sun City West, Arizona, United States

Banner Boswell Imaging Center; 🇺🇸 Sun City, Arizona, United States

Banner Del E Webb Outpatient Diagnostics; 🇺🇸 Sun City West, Arizona, United States

Banner Boswell Medical Center; 🇺🇸 Sun City, Arizona, United States

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States