Back to resultsTypes of Fixation in Arthroscopic Rotator Cuff Repair
Primary Purpose
Rotator Cuff Tear
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
single row
double row fixation
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Tear focused on measuring full thickness rotator cuff tear
Eligibility 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
Sites / Locations
- The Ottawa Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
single row fixation
double row fixation
Arm Description
Outcomes
Primary Outcome Measures
Western Ontario Rotator Cuff Index (WORC)
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
Constant Score
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.
ASES Score
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.
Strength Test
Shoulder strength in forward elevation was measured in kg using a portable scale.
Healing Rate
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).
Full Information
NCT ID
NCT00508183
First Posted
July 25, 2007
Last Updated
March 25, 2020
Sponsor
Ottawa Hospital Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT00508183
Brief Title
Types of Fixation in Arthroscopic Rotator Cuff Repair
Official Title
Single Row Versus Double Row Fixation in Arthroscopic Cuff Repair; a Randomized Controlled Sutdy.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 2007 (Actual)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear
Keywords
full thickness rotator cuff tear
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
single row fixation
Arm Type
Active Comparator
Arm Title
double row fixation
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
single row
Intervention Description
This method involves using a single row of anchor(s) to reattach the cuff to the bone.
Intervention Type
Procedure
Intervention Name(s)
double row fixation
Intervention Description
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 Measure Information:
Title
Western Ontario Rotator Cuff Index (WORC)
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Constant Score
Description
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.
Time Frame
2 Year
Title
ASES Score
Description
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.
Time Frame
2 Year
Title
Strength Test
Description
Shoulder strength in forward elevation was measured in kg using a portable scale.
Time Frame
2 Years
Title
Healing Rate
Description
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).
Time Frame
1 Year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Lapner, MD
Organizational Affiliation
OHRI
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
22810395
Citation
Lapner PL, Sabri E, Rakhra K, McRae S, Leiter J, Bell K, Macdonald P. A multicenter randomized controlled trial comparing single-row with double-row fixation in arthroscopic rotator cuff repair. J Bone Joint Surg Am. 2012 Jul 18;94(14):1249-57. doi: 10.2106/JBJS.K.00999.
Results Reference
result
PubMed Identifier
34398641
Citation
Lapner P, Li A, Pollock JW, Zhang T, McIlquham K, McRae S, MacDonald P. A Multicenter Randomized Controlled Trial Comparing Single-Row With Double-Row Fixation in Arthroscopic Rotator Cuff Repair: Long-Term Follow-up. Am J Sports Med. 2021 Sep;49(11):3021-3029. doi: 10.1177/03635465211029029. Epub 2021 Aug 16.
Results Reference
derived
Learn more about this trial
Types of Fixation in Arthroscopic Rotator Cuff Repair
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