Types of Fixation in Arthroscopic Rotator Cuff Repair

Not Applicable

Completed

• Conditions: Rotator Cuff Tear
• Interventions: Procedure: single row; Procedure: double row fixation

• Registration Number: NCT00508183
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-07-25
• Study First Submitted QC: 2007-07-26
• Study First Posted: 2007-07-27
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Results First Submitted: 2017-04-04
• Results First Submitted QC: 2017-07-05
• Results First Posted: 2018-01-29
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-25
• Last Update Posted: 2020-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
single row fixation	single row	-
double row fixation	double row fixation	-

Primary Outcome Measures

Name	Time	Method
Western Ontario Rotator Cuff Index (WORC)	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

Name	Time	Method
Constant Score	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	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	2 Years	Shoulder strength in forward elevation was measured in kg using a portable scale.
Healing Rate	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).

Trial Locations

Locations (1)

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada