Types of Fixation in Arthroscopic Rotator Cuff Repair

Ottawa Hospital Research Institute90 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Rotator Cuff Tear

Interventions

single rowPROCEDURE

This method involves using a single row of anchor(s) to reattach the cuff to the bone.

double row fixationPROCEDURE

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.

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

The Ottawa Hospital

Ottawa, Ontario, Canada

Outcomes

Primary Outcomes

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.

Time frame: 2 years

Secondary Outcomes

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.

Time frame: 2 Year

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.

Time frame: 2 Year

Strength Test

Shoulder strength in forward elevation was measured in kg using a portable scale.

Time frame: 2 Years

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).

Time frame: 1 Year

Data from ClinicalTrials.gov

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