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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02059473
Other study ID # acutecufftearhannahallgren
Secondary ID
Status Recruiting
Phase N/A
First received February 4, 2014
Last updated February 7, 2014
Start date November 2013
Est. completion date November 2017

Study information

Verified date February 2014
Source University Hospital, Linkoeping
Contact n/a
Is FDA regulated No
Health authority Sweden: The National Board of Health and Welfare
Study type Interventional

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date November 2017
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Rotator cuff repair
Physiotherapy & Surgery
Physiotherapy


Locations

Country Name City State
Sweden Orthopedic Clinic, Linköping University Hospital Linköping

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Other Euro-Qol-five-Dimensions (EQ-5D) Quality of life assessment Twelve months No
Other Patient Global Impression of Change (PGIC) Patients Global impression of Change Twelve months No
Primary Constant-Murley Shoulder Assessment score Twelve months No
Secondary Western Ontario Rotator Cuff score Shoulder specific, patient reported outcome score Twelve months No
Secondary MRI Magnetic Resonance imaging. Gives a measure of muscle atrophy, fatty infiltration, rerupture and enlargement of the tendon rupture. Twelve months No
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