Clinical trial NCT00739947: Arthroscopic Surgical Outcome Study In Subjects With Rotator Cuff Tears
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rotator Cuff
Arthroscopic Surgery
Keywords: Observational
rotator cuff tear
arthroscopic
surgical
outcome study
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-08-22
Enrollment: 162
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community Sample

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 1 year
Secondary outcomes:
measure: 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.
timeFrame: 1 year
measure: Determination of the correlation between imaging biomarkers (muscle atrophy and fatty infiltration) and the subjects outcome (retear and function).
timeFrame: 1 year
measure: Estimation of the relationship between patient reported outcomes and subject's surgical and functional outcomes.
timeFrame: 1 year
measure: Evaluation of the ability to define
timeFrame: 1 year
measure: 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.
timeFrame: 1 year
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: The Core Institute
state: Arizona
city: Phoenix
country: United States
facility: Desert Valley Radiology
state: Arizona
city: Phoenix
country: United States
facility: Paradise Valley Hospital
state: Arizona
city: Phoenix
country: United States
facility: Desert Valley Radiology
state: Arizona
city: Sun City West
country: United States
facility: Banner Del E Webb Medical Center
state: Arizona
city: Sun City West
country: United States
facility: Banner Del E Webb Outpatient Diagnostics
state: Arizona
city: Sun City West
country: United States
facility: The CORE Institute-Sun City West
state: Arizona
city: Sun City
country: United States
facility: Banner Boswell Imaging Center
state: Arizona
city: Sun City
country: United States
facility: Banner Boswell Medical Center
state: Arizona
city: Sun City
country: United States
facility: The Core Institute
state: Arizona
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: New Haven
country: United States
facility: Yale-New Haven Hospital
state: Connecticut
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Waltham
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Rochester
country: United States
facility: University Orthopaedic Associates
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Providence
country: United States
facility: University Orthopedics
state: Rhode Island
city: Providence
country: United States
facility: University Orthopedics, Inc.
state: Rhode Island
city: Bedford
country: United States
facility: Texas Orthopedic Specialists, PA
state: Texas
city: Grapevine
country: United States
facility: Orthopedic Specialists
state: Texas
city: Grapevine
country: United States
facility: Preferred Imaging
state: Texas
city: Houston
country: United States
facility: Kelsey Research Foundation
state: Texas
city: Houston
country: United States
facility: Kelsey-Seybold Spring Medical and Diagnostic Center
state: Texas
city: Houston
country: United States
facility: Kelsey Seybold Clinic
state: Texas
city: Houston
country: United States
facility: St. Luke's Episcopal Hospital
state: Texas
city: Southlake
country: United States
facility: Harris Methodist Southlake
state: Texas
city: Everett
country: United States
facility: The Everett Clinic
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: