Arthroscopic Surgical Outcome Study In Subjects With Rotator Cuff Tears

Rotator Cuff Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00739947
• Other study ID #: 3202V1-1000
• Secondary ID: B1861001
• Status: Completed
• Start date: October 13, 2008
• Est. completion date: July 5, 2011

Study information

• Verified date: February 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: July 5, 2011
• Est. primary completion date: July 5, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthroscopic Surgery
• Rotator Cuff
• Rotator Cuff Injuries

Intervention

Other:
• Observational study of the surgical outcome
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.

Locations

Country	Name	City	State
United States	Texas Orthopedic Specialists, PA	Bedford	Texas
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Cleveland Clinic	Cleveland	Ohio
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	The Everett Clinic	Everett	Washington
United States	Orthopedic Specialists	Grapevine	Texas
United States	Preferred Imaging	Grapevine	Texas
United States	Kelsey Research Foundation	Houston	Texas
United States	Kelsey Seybold Clinic	Houston	Texas
United States	Kelsey-Seybold Spring Medical and Diagnostic Center	Houston	Texas
United States	St. Luke's Episcopal Hospital	Houston	Texas
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Yale-New Haven Hospital	New Haven	Connecticut
United States	Hospital for Special Surgery	New York	New York
United States	Mount Sinai Medical Center	New York	New York
United States	Desert Valley Radiology	Phoenix	Arizona
United States	Desert Valley Radiology	Phoenix	Arizona
United States	Paradise Valley Hospital	Phoenix	Arizona
United States	The Core Institute	Phoenix	Arizona
United States	University Orthopedics	Providence	Rhode Island
United States	University Orthopedics, Inc.	Providence	Rhode Island
United States	University of Rochester Medical Center	Rochester	New York
United States	University of Rochester Medical Center	Rochester	New York
United States	University Orthopaedic Associates	Rochester	New York
United States	University of California, San Francisco	San Francisco	California
United States	University of California, San Francisco	San Francisco	California
United States	University of California, San Francisco	San Francisco	California
United States	University of California, San Francisco	San Francisco	California
United States	University of California, San Francisco	San Francisco	California
United States	Harris Methodist Southlake	Southlake	Texas
United States	Banner Boswell Imaging Center	Sun City	Arizona
United States	Banner Boswell Medical Center	Sun City	Arizona
United States	The Core Institute	Sun City	Arizona
United States	Banner Del E Webb Medical Center	Sun City West	Arizona
United States	Banner Del E Webb Outpatient Diagnostics	Sun City West	Arizona
United States	The CORE Institute-Sun City West	Sun City West	Arizona
United States	Massachusetts General Hospital	Waltham	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Determination of the correlation between imaging biomarkers (muscle atrophy and fatty infiltration) and the subjects outcome (retear and function).		1 year
Secondary	Estimation of the relationship between patient reported outcomes and subject's surgical and functional outcomes.		1 year
Secondary	Evaluation of the ability to define		1 year
Secondary	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

External Links

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