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

Pfizer29 sites in 1 country162 target enrollmentOctober 13, 2008

ConditionsRotator Cuff Arthroscopic Surgery

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Rotator Cuff
Sponsor: Pfizer
Enrollment: 162
Locations: 29
Primary Endpoint: 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.
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 13, 2008

End Date

July 5, 2011

Last Updated

5 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

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.

Time Frame: 1 year

Secondary Outcomes

Evaluation of the ability to define(1 year)
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)