Types of Fixation in Arthroscopic Rotator Cuff Repair

This study is currently recruiting participants.

Verified by Ottawa Health Research Institute, July 2007

Sponsored by:	Ottawa Health Research Institute
Information provided by:	Ottawa Health Research Institute
ClinicalTrials.gov Identifier:	NCT00508183

Purpose

The study will identify if there is a difference of quality of life after surgery between two techniques used in surgery. The two different techniques are either the Single Row Fixation or the Double Row Fixation.

Condition
Rotator Cuff Tear

U.S. FDA Resources

Study Type:	Observational
Study Design:	Natural History, Cross-Sectional, Defined Population, Prospective Study
Official Title:	Single Row Versus Double Row Fixation in Arthroscopic Cuff Repair; a Randomized Controlled Sutdy.

Further study details as provided by Ottawa Health Research Institute:

Estimated Enrollment:	80
Study Start Date:	April 2007
Estimated Study Completion Date:	April 2009

Detailed Description:

Primary Research Question; What is the difference in disease specific quality of life between patients who undergo a repair of the rotator cuff with arthroscopic technique using single-row fixation, versus double-row fixation, as measured by the Western Ontario Rotator Cuff Index (WORC)at one year post op?

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Patients who have failed standard non-surgical management of their rotator cuff tear, and who would benefit from a surgical repair of the cuff.
Imaging and intra-operative findings confirming a full thickness tear of the rotator cuff.

Exclusion Criteria:

Characteristics of the cuff tear that render the cuff irrepairable.
Significant shoulder comorbidities
Previous surgery on affected shoulder
Patients with active workers compensation claims
Active joint or systemic infection
Significant muscle paralysis
Rotatorcuff tear arthropathy
Charcots arthropathy
Major medical illness
Unable to speak or read English
Psychiatric illness that precludes informed consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00508183

Contacts

Contact: Peter Lapner, MD

(613) 737-8377

Locations

Canada, Ontario
The Ottawa Hospital	Recruiting
Ottawa, Ontario, Canada, K1Y 4E9

Sponsors and Collaborators

Ottawa Health Research Institute

Investigators

Principal Investigator:

Peter Lapner, MD

OHRI

More Information

Study ID Numbers:	OHREB2006862-01H
Study First Received:	July 25, 2007
Last Updated:	July 26, 2007
ClinicalTrials.gov Identifier:	NCT00508183
Health Authority:	Canada: Health Canada

Keywords provided by Ottawa Health Research Institute:

full thickness rotator cuff tear

Study placed in the following topic categories:

Lacerations

ClinicalTrials.gov processed this record on January 16, 2009