Arthroscopic Rotator Cuff Tear Repair: Single Versus Double Layer Fixation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-18

Study Completion Date

2022-12-31

Brief Summary

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Retear rates after arthroscopic rotator cuff repairs remain unsatisfactorily high. Recently, attention has been paid to restore the rotator cuff's native anatomy by reconstructing the superior joint capsule. However, the debate whether to reconstruct only the superficial tendinous part or also the deeper capsulo-ligamentous part of the rotator cuff is ongoing. Thus, the intention of the present study is to compare double-layer versus single-layer arthroscopic rotator cuff repair regarding retear rate and clinical outcome.

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Detailed Description

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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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double layer fixation

Patients with torn infraspinatus and supraspinatus tendon undergoing arthroscopy rotator cuff repair with double layer fixation

Group Type EXPERIMENTAL

double layer fixation

Intervention Type PROCEDURE

single layer fixation

Patients with torn infraspinatus and supraspinatus tendon undergoing arthroscopy rotator cuff repair with single layer fixation

Group Type EXPERIMENTAL

single layer fixation

Intervention Type PROCEDURE

Interventions

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double layer fixation

Intervention Type PROCEDURE

single layer fixation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients with repairable supra- and infraspinatus tears scheduled for arthroscopic rotator cuff fixation
* tear size of at least 2.5 cm and up to 4.0 cm
* signed informed consent