Types of Fixation in Arthroscopic Rotator Cuff Repair

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2011-07-31

Brief Summary

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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.

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Detailed Description

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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?

Conditions

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Rotator Cuff Tear

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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single row fixation

Group Type ACTIVE_COMPARATOR

single row

Intervention Type PROCEDURE

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

double row fixation

Group Type ACTIVE_COMPARATOR

double row fixation

Intervention Type PROCEDURE

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.

Interventions

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single row

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

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes