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

Purpose

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.

Condition	Intervention
Rotator Cuff Injury	Other: Observational study of the surgical outcome

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

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

Further study details as provided by Wyeth:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	160
Study Start Date:	August 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Standard of Care	Other: Observational study of the surgical outcome

Eligibility

Ages Eligible for Study:	21 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Community Sample

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00739947

Contacts


Contact: Trial Manager		clintrialparticipation@wyeth.com

Locations


United States, Arizona
		Not yet recruiting
	Phoenix, Arizona, United States, 85032

United States, Arkansas
		Not yet recruiting
	Little Rock, Arkansas, United States, 72205

United States, Massachusetts
		Not yet recruiting
	Boston, Massachusetts, United States, 02114

United States, New York
		Recruiting
	New York, New York, United States, 10029
		Not yet recruiting
	New York, New York, United States, 10021

United States, Ohio
		Recruiting
	Cleveland, Ohio, United States, 44195

United States, Rhode Island
		Not yet recruiting
	Providence, Rhode Island, United States, 02905

United States, Texas
		Not yet recruiting
	Houston, Texas, United States, 77025

United States, Washington
		Recruiting
	Everett, Washington, United States, 98201

Sponsors and Collaborators

Wyeth

Investigators


Study Director:	Medical Monitor	Wyeth

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3202V1-1000
First Received:	August 21, 2008
Last Updated:	October 10, 2008
ClinicalTrials.gov Identifier:	NCT00739947
Health Authority:	United States: Institutional Review Board

Keywords provided by Wyeth:

Observational surgical outcome study

Study placed in the following topic categories:

Lacerations

ClinicalTrials.gov processed this record on October 15, 2008

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00739947