Treatment of Small Acute Cuff Tears, a Randomized Study

Rotator Cuff Tear Clinical Trial

Official title:

Treatment of Small Acute Full-thickness tears-a Prospective Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02059473
• Other study ID #: acutecufftearhannahallgren
• 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

• Rotator Cuff Tear

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