Treatment of Small Acute Cuff Tears, a Randomized Study

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

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2017-11-30

Brief Summary

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The purpose of this project is to compare operative repair of traumatically torn rotator cuff tendon with physiotherapy in a randomized prospective study.

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Detailed Description

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In clinical practice most patients with a traumatic acute rotator cuff tear are treated with operative repair. The results of surgery are in most cases good but there are also good results in the literature from conservative treatment. So far there has been no prospective randomized comparison between the two treatments. When it comes to degenerative non-traumatic tears, level 1 and 2 studies have not been able to show the superiority of surgery.

This study takes place in 2 clinics in Sweden (Linköping and Kalmar). Patients who have no previous shoulder conditions, a trauma to the shoulder and pain and/or inability to lift their arm will undergo magnetic resonance imaging (MRI). If this indicates a full-thickness rotator cuff tear of the cranial part of the rotator cuff the patient will be randomized to surgery or physiotherapy. Surgical intervention is mini-open repair.

Follow-up takes place at 3 months, 6 months and 12 months with patient scores taken by a blinded independent physiotherapist. At 12 months a new MRI is conducted as well.

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

SINGLE

Outcome Assessors

Study Groups

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Physiotherapy & Surgery

Mini-open rotator cuff repair

Group Type EXPERIMENTAL

Rotator cuff repair

Intervention Type PROCEDURE

Physiotherapy \& Surgery

Physiotherapy

Intervention Type PROCEDURE

Physiotherapy

Structured physiotherapy

Group Type ACTIVE_COMPARATOR

Physiotherapy

Intervention Type PROCEDURE

Interventions

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Rotator cuff repair

Physiotherapy \& Surgery

Intervention Type PROCEDURE

Physiotherapy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Trauma to the shoulder
* Full thickness cranial rotator cuff tear
* Operation possible within 3 months

Exclusion Criteria

* 2 or more rotator cuff tendons involved
* Fracture
* Dislocation
* Previous shoulder condition (symptomatic osteoarthritis (Gleno-humeral (GH) joint, Acromial-Clavicular (AC) joint), frozen shoulder, instability, tumor)
* Malignancy
* Rheumatic disease
* Inability to understand swedish
* Substance abuse

Eligible Sex

ALL

Accepts Healthy Volunteers

No