We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00852657
Recruitment Status : Active, not recruiting
First Posted : February 27, 2009
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Stefan Moosmayer, Martina Hansen's Hospital

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.

Condition or disease Intervention/treatment
Rotator Cuff Tear Procedure: Tendon repair with acromioplasty Procedure: Physiotherapy

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : September 2004
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Constant score [ Time Frame: baseline, 6 months, 1, 2, 5, 10 years ]

Secondary Outcome Measures :
  1. self report section of the American Shoulder and Elbow Surgeons score (ASES) [ Time Frame: baseline, 6 months, 1, 2, 5, 10 years ]
  2. Short Form 36 Health Survey (SF-36) [ Time Frame: baseline, 6 months, 1, 2, 5, 10 years ]
  3. Patient satisfaction [ Time Frame: 1, 2, 5, 10 years ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00852657


Locations
Norway
Martina Hansen's Hospital
Sandvika, 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

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)
First Posted: February 27, 2009    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

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

Additional relevant MeSH terms:
Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries