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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Stefan Moosmayer, Martina Hansen's Hospital
ClinicalTrials.gov Identifier:
NCT00852657
First received: February 26, 2009
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Rotator Cuff Tear
Procedure: Tendon repair with acromioplasty
Procedure: Physiotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Surgical Treatment by Tendon Repair and Physiotherapy in the Treatment of Small and Medium-sized Tears of the Rotator Cuff

Further study details as provided by Martina Hansen's Hospital:

Primary Outcome Measures:
  • Constant score [ Time Frame: baseline, 6 months, 1, 2, 5, 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • self report section of the American Shoulder and Elbow Surgeons score (ASES) [ Time Frame: baseline, 6 months, 1, 2, 5, 10 years ] [ Designated as safety issue: No ]
  • Short Form 36 Health Survey (SF-36) [ Time Frame: baseline, 6 months, 1, 2, 5, 10 years ] [ Designated as safety issue: No ]
  • Patient satisfaction [ Time Frame: 1, 2, 5, 10 years ] [ Designated as safety issue: No ]

Enrollment: 103
Study Start Date: September 2004
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Surgical treatment
Open or mini-open tendon repair with acromioplasty
Procedure: Tendon repair with acromioplasty
Open or mini-open tendon repair in combination with an acromioplasty and eventually a tenodesis of the long head of the biceps
Active Comparator: Physiotherapy
Physiotherapy by exercises
Procedure: Physiotherapy
According to a rehabilitation program which was established prior to study start.

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 and 5 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00852657

Locations
Norway
Martina Hansen's Hospital
Baerum, Norway, 1306
Sponsors and Collaborators
Martina Hansen's Hospital
Investigators
Principal Investigator: Stefan Moosmayer, MD Martina Hansen's Hospital
Study Chair: Hans-Joergen Smith, MD, PhD University of Oslo, Rikshospitalet
  More Information

Publications:
Responsible Party: Stefan Moosmayer, MD, PhD, Martina Hansen's Hospital
ClinicalTrials.gov Identifier: NCT00852657     History of Changes
Other Study ID Numbers: 430-04149 (REK), 430-04149 (REK), 11220 (NSD)
Study First Received: February 26, 2009
Last Updated: May 29, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Social Science Data Services

Keywords provided by Martina Hansen's Hospital:
Rotator cuff tear
surgical repair
Physiotherapy
Treatment benefit
Surgery

ClinicalTrials.gov processed this record on October 22, 2014