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Treatment of Small Acute Cuff Tears, a Randomized Study

Primary Purpose

Rotator Cuff Tear

Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Rotator cuff repair
Physiotherapy
Sponsored by
University Hospital, Linkoeping
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tear

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Orthopedic Clinic, Linköping University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Physiotherapy & Surgery

Physiotherapy

Arm Description

Mini-open rotator cuff repair

Structured physiotherapy

Outcomes

Primary Outcome Measures

Constant-Murley Shoulder Assessment score

Secondary Outcome Measures

Western Ontario Rotator Cuff score
Shoulder specific, patient reported outcome score
MRI
Magnetic Resonance imaging. Gives a measure of muscle atrophy, fatty infiltration, rerupture and enlargement of the tendon rupture.

Full Information

First Posted
February 4, 2014
Last Updated
February 7, 2014
Sponsor
University Hospital, Linkoeping
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1. Study Identification

Unique Protocol Identification Number
NCT02059473
Brief Title
Treatment of Small Acute Cuff Tears, a Randomized Study
Official Title
Treatment of Small Acute Full-thickness tears-a Prospective Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
November 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Linkoeping

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physiotherapy & Surgery
Arm Type
Experimental
Arm Description
Mini-open rotator cuff repair
Arm Title
Physiotherapy
Arm Type
Active Comparator
Arm Description
Structured physiotherapy
Intervention Type
Procedure
Intervention Name(s)
Rotator cuff repair
Intervention Description
Physiotherapy & Surgery
Intervention Type
Procedure
Intervention Name(s)
Physiotherapy
Primary Outcome Measure Information:
Title
Constant-Murley Shoulder Assessment score
Time Frame
Twelve months
Secondary Outcome Measure Information:
Title
Western Ontario Rotator Cuff score
Description
Shoulder specific, patient reported outcome score
Time Frame
Twelve months
Title
MRI
Description
Magnetic Resonance imaging. Gives a measure of muscle atrophy, fatty infiltration, rerupture and enlargement of the tendon rupture.
Time Frame
Twelve months
Other Pre-specified Outcome Measures:
Title
Euro-Qol-five-Dimensions (EQ-5D)
Description
Quality of life assessment
Time Frame
Twelve months
Title
Patient Global Impression of Change (PGIC)
Description
Patients Global impression of Change
Time Frame
Twelve months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Adolfsson, Professor
Organizational Affiliation
Linkoeping University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orthopedic Clinic, Linköping University Hospital
City
Linköping
ZIP/Postal Code
58185
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanna Hallgren, MD
Phone
+46 10 1037205
Email
hanna.bjornsson.hallgren@lio.se
First Name & Middle Initial & Last Name & Degree
Mats Ranebo, MD
Phone
+46 480 81432
Email
matsra@ltkalmar.se
First Name & Middle Initial & Last Name & Degree
Hanna Hallgren, MD

12. IPD Sharing Statement

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Treatment of Small Acute Cuff Tears, a Randomized Study

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