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Types of Fixation in Arthroscopic Rotator Cuff Repair

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00508183
First received: July 25, 2007
Last updated: October 24, 2011
Last verified: September 2011
History of Changes
  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 Intervention
Rotator Cuff Tear
 Procedure: single row
Procedure: double row fixation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Single Row Versus Double Row Fixation in Arthroscopic Cuff Repair; a Randomized Controlled Sutdy.

Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Do patients who undergo a repair of the rotator cuff with arthroscopic technique using double row fixation have increased disease specific quality of life then patients who undergo a repair with arthroscopic technique using single-row fixation. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: April 2007
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: single row fixation Procedure: single row
This method involves using a single row of anchor(s) to reattach the cuff to the bone.
Other Name: non applicable
Active Comparator: double row fixation Procedure: double row fixation
This technique, "double row" fixation, involves adding an extra anchor(s) over the number used for single row fixation. This extra anchor(s) is placed further inside the bone and may help to increase the fixation strength of the repair.
Other Name: non applicable

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

Locations
Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1Y 4E9
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Principal Investigator: Peter Lapner, MD OHRI
  More Information

No publications provided

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00508183     History of Changes
Other Study ID Numbers: OHREB2006862-01H
Study First Received: July 25, 2007
Last Updated: October 24, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Ottawa Hospital Research Institute:
full thickness rotator cuff tear

ClinicalTrials.gov processed this record on May 16, 2013