Arthroscopic Surgical Outcome Study in Subjects With Rotator Cuff Tears - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

August 21, 2008

Last Updated Date

May 4, 2009

Start Date ^†

August 2008

Current Primary Outcome Measures ^†

MRI [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00739947 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Range of Motion and Strength [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Brief Summary

This study involves subjects with full-thickness rotator cuff tears treated by means of arthroscopic 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

Study Phase

Study Type ^†

Observational

Study Design ^†

Cohort, Prospective

Condition ^†

Rotator Cuff Injury

Intervention ^†

Other: Observational study of the surgical outcome

Study Arms / Comparison Groups

Standard of Care

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

160

Estimated Completion Date

September 2010

Estimated Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion:

Full thickness Rotator Cuff Tears less than 2 cm and less than 4cm
Planned procedure for repair is tendon-to-bone repair by means of an arthroscopy

Exclusion:

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

Gender

Both

Ages

21 Years to 75 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Contact: Trial Manager

clintrialparticipation@wyeth.com

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00739947

Responsible Party

Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth

Secondary IDs ^††

Study Sponsor ^†

Wyeth

Collaborators ^††

Investigators ^†

Study Director:

Medical Monitor

Wyeth

Information Provided By

Wyeth

Verification Date

May 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.