Types of Fixation in Arthroscopic Rotator Cuff Repair

Ottawa Hospital Research Institute

Status: Completed

Conditions: Rotator Cuff Tear

Treatments: Procedure: single row; Procedure: double row fixation

Study type: Interventional

Funder types: Other

Identifiers

NCT00508183

OHREB2006862-01H

Details and patient eligibility

About

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.

Full 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?

Enrollment: 90 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups

single row fixation

Active Comparator group

Treatment:

Procedure: single row

double row fixation

Active Comparator group

Treatment:

Procedure: double row fixation