Types of Fixation in Arthroscopic Rotator Cuff Repair
|ClinicalTrials.gov Identifier: NCT00508183|
Recruitment Status : Completed
First Posted : July 27, 2007
Results First Posted : January 29, 2018
Last Update Posted : March 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Rotator Cuff Tear||Procedure: single row Procedure: double row fixation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
|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.
- 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.
- 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.
- 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.
- Strength Test [ Time Frame: 2 Years ]Shoulder strength in forward elevation was measured in kg using a portable scale.
- 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).
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
|The Ottawa Hospital|
|Ottawa, Ontario, Canada, K1Y 4E9|
|Principal Investigator:||Peter Lapner, MD||OHRI|