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Types of Fixation in Arthroscopic Rotator Cuff Repair

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ClinicalTrials.gov Identifier: NCT00508183
Recruitment Status : Completed
First Posted : July 27, 2007
Results First Posted : January 29, 2018
Last Update Posted : March 15, 2018
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Brief Summary:
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 or disease Intervention/treatment Phase
Rotator Cuff Tear Procedure: single row Procedure: double row fixation Not 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?

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Single Row Versus Double Row Fixation in Arthroscopic Cuff Repair; a Randomized Controlled Sutdy.
Actual Study Start Date : June 2007
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  1. Western Ontario Rotator Cuff Index (WORC) [ Time Frame: 2 years ]
    Do patients who undergo a repair of the rotator cuff with arthroscopic technique using double row fixation have increased disease specific quality of life (measured by WORC) then patients who undergo a repair with arthroscopic technique using single-row fixation? The WORC scale is from 0% to 100%, with a higher value being indicative of better disease specific quality of life.


Secondary Outcome Measures :
  1. Constant Score [ Time Frame: 2 Year ]
    Differences in outcome between the two groups as measured by the Constant score. The constant score ranges from 1 to 100 with a higher value indicative of better shoulder function.

  2. ASES Score [ Time Frame: 2 Year ]
    Determination of differences in outcome between the two groups as measured by the American Shoulder and Elbow Surgeons (ASES) score. The ASES score ranges from 0 to 100 with a higher number indicative of better function.

  3. Strength Test [ Time Frame: 2 Years ]
    Shoulder strength in forward elevation was measured in kg using a portable scale.

  4. Healing Rate [ Time Frame: 1 Year ]
    Percentage of Participants who had healed by 1 year post-surgery as measured using magnetic resonance imaging. If the tendons were in continuity with no evidence of full-thickness tearing, the repair was considered healed (intact).



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00508183     History of Changes
Other Study ID Numbers: OHREB2006862-01H
First Posted: July 27, 2007    Key Record Dates
Results First Posted: January 29, 2018
Last Update Posted: March 15, 2018
Last Verified: February 2018

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

Additional relevant MeSH terms:
Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries