search
Back to results

Comparison of Tendon Repair and Physiotherapy in the Treatment of Small and Medium-sized Tears of the Rotator Cuff

Primary Purpose

Rotator Cuff Tear

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Tendon repair with acromioplasty
Physiotherapy
Sponsored by
Martina Hansen's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tear focused on measuring Rotator cuff tear, surgical repair, Physiotherapy, Treatment benefit, Surgery

Eligibility Criteria

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

Inclusion Criteria:

  • Clinical history and imaging findings of a rotator cuff tear

Exclusion Criteria:

  • Presence of other local or systemic diseases influencing on shoulder function
  • History of earlier rotator cuff surgery
  • Medical contraindications for surgery

Sites / Locations

  • Martina Hansen's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Surgical treatment

Physiotherapy

Arm Description

Open or mini-open tendon repair with acromioplasty

Physiotherapy by exercises

Outcomes

Primary Outcome Measures

Constant score

Secondary Outcome Measures

self report section of the American Shoulder and Elbow Surgeons score (ASES)
Short Form 36 Health Survey (SF-36)
Patient satisfaction

Full Information

First Posted
February 26, 2009
Last Updated
March 13, 2023
Sponsor
Martina Hansen's Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT00852657
Brief Title
Comparison of Tendon Repair and Physiotherapy in the Treatment of Small and Medium-sized Tears of the Rotator Cuff
Official Title
Comparison of Surgical Treatment by Tendon Repair and Physiotherapy in the Treatment of Small and Medium-sized Tears of the Rotator Cuff
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
March 2023 (Actual)
Study Completion Date
March 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Martina Hansen's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare treatment benefits from surgical treatment by tendon repair and from physiotherapy for small and medium-sized rotator cuff tears.
Detailed Description
Surgical treatment by tendon repair or physiotherapy are accepted treatment options for small and medium-sized rotator cuff tears, but have never been compared in randomised, controlled studies. In this study, patients presenting clinical signs together with imaging findings (MRI and sonography) for a full-thickness rotator cuff tear will be randomly allocated to surgery (tendon repair) or physiotherapy. Outcome measuring will be performed by the Constant score, the self report section of the American Shoulder and Elbow Surgeons score (ASES), the Short Form 36 Health Survey (SF-36) and subscores for shoulder motion, pain, strength and patient satisfaction. Scores will be taken at baseline and after 6 months,1, 2, 5, 10 and 15 years by a blinded assessor. All operated shoulders will be controlled by MRI after one year. Patients with no effect from physiotherapy after at least 15 treatment sessions will be offered secondary surgical treatment, and scoring results from last follow-up before surgery will be carried forward to analysis, according to an intention to treat principle.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear
Keywords
Rotator cuff tear, surgical repair, Physiotherapy, Treatment benefit, Surgery

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Surgical treatment
Arm Type
Active Comparator
Arm Description
Open or mini-open tendon repair with acromioplasty
Arm Title
Physiotherapy
Arm Type
Active Comparator
Arm Description
Physiotherapy by exercises
Intervention Type
Procedure
Intervention Name(s)
Tendon repair with acromioplasty
Intervention Description
Open or mini-open tendon repair in combination with an acromioplasty and eventually a tenodesis of the long head of the biceps
Intervention Type
Procedure
Intervention Name(s)
Physiotherapy
Intervention Description
According to a rehabilitation program which was established prior to study start.
Primary Outcome Measure Information:
Title
Constant score
Time Frame
baseline, 6 months, 1, 2, 5, 10, 15 years
Secondary Outcome Measure Information:
Title
self report section of the American Shoulder and Elbow Surgeons score (ASES)
Time Frame
baseline, 6 months, 1, 2, 5, 10, 15 years
Title
Short Form 36 Health Survey (SF-36)
Time Frame
baseline, 6 months, 1, 2, 5, 10, 15 years
Title
Patient satisfaction
Time Frame
1, 2, 5, 10, 15 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical history and imaging findings of a rotator cuff tear Exclusion Criteria: Presence of other local or systemic diseases influencing on shoulder function History of earlier rotator cuff surgery Medical contraindications for surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Moosmayer, MD
Organizational Affiliation
Martina Hansen's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hans-Joergen Smith, MD, PhD
Organizational Affiliation
University of Oslo, Rikshospitalet
Official's Role
Study Chair
Facility Information:
Facility Name
Martina Hansen's Hospital
City
Sandvika
ZIP/Postal Code
1306
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
20044684
Citation
Moosmayer S, Lund G, Seljom U, Svege I, Hennig T, Tariq R, Smith HJ. Comparison between surgery and physiotherapy in the treatment of small and medium-sized tears of the rotator cuff: A randomised controlled study of 103 patients with one-year follow-up. J Bone Joint Surg Br. 2010 Jan;92(1):83-91. doi: 10.1302/0301-620X.92B1.22609.
Results Reference
result
PubMed Identifier
25232074
Citation
Moosmayer S, Lund G, Seljom US, Haldorsen B, Svege IC, Hennig T, Pripp AH, Smith HJ. Tendon repair compared with physiotherapy in the treatment of rotator cuff tears: a randomized controlled study in 103 cases with a five-year follow-up. J Bone Joint Surg Am. 2014 Sep 17;96(18):1504-14. doi: 10.2106/JBJS.M.01393.
Results Reference
result
PubMed Identifier
31220021
Citation
Moosmayer S, Lund G, Seljom US, Haldorsen B, Svege IC, Hennig T, Pripp AH, Smith HJ. At a 10-Year Follow-up, Tendon Repair Is Superior to Physiotherapy in the Treatment of Small and Medium-Sized Rotator Cuff Tears. J Bone Joint Surg Am. 2019 Jun 19;101(12):1050-1060. doi: 10.2106/JBJS.18.01373.
Results Reference
result

Learn more about this trial

Comparison of Tendon Repair and Physiotherapy in the Treatment of Small and Medium-sized Tears of the Rotator Cuff

We'll reach out to this number within 24 hrs