Treatment of Atraumatic Rotator Cuff Rupture in Elderly Patients (toarcriep)

This study has been completed.
Sponsor:
Collaborators:
Tampere University Hospital
Kuopio University Hospital
Information provided by (Responsible Party):
Ville Aarimaa, Turku University Hospital
ClinicalTrials.gov Identifier:
NCT01116518
First received: April 29, 2010
Last updated: November 24, 2013
Last verified: May 2010
  Purpose

The purpose of the investigators study is to compare the effect of: 1) physiotherapy 2) arthroscopic acromioplasty and debridement or 3) arthroscopic rotator cuff reconstruction and acromioplasty in the treatment of degenerative, atraumatic rotator cuff rupture.


Condition Intervention
Atraumatic Rotator Cuff Rupture
Procedure: physiotherapy
Procedure: acromioplasty
Procedure: acromioplasty and rotator cuff reconstruction

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Atraumatic Rotator Cuff Rupture in Elderly Patients

Resource links provided by NLM:


Further study details as provided by Turku University Hospital:

Primary Outcome Measures:
  • Shoulder score by Constant and Murley [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Constant scoring is endorsed by SECEC/ESSSE and is the most largely used instrument measuring shoulder pain, function and strenght. This scoring system is very suited for evaluating disability caused by rotator cuff ruptures.

  • Constant score [ Designated as safety issue: No ]
    subjective and objective shoulder score


Enrollment: 180
Study Start Date: February 2009
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: physiotherapy Procedure: physiotherapy
Active Comparator: acromioplasty Procedure: acromioplasty
Active Comparator: acromioplasty and rotator cuff reconstruction Procedure: acromioplasty and rotator cuff reconstruction

Detailed Description:

The study will be conducted according to the revised Declaration of Helsinki by The World Medical Association and the ICH-guidelines for good clinical trial practice. The study will be submitted for approval to the Ethics Committee of the Hospital District of Varsinais-Suomi, Finland. A written informed consent will be obtained from each patient.

This study will be conducted at three different hospitals i.e. Turku University Hospital, Tampere University Hospital (Hatanpää hospital) and Kuopio University Hospital as a multicenter study. A total of 180 patients, 60 patients at each hospital, will be included in this study. The patients are clinically examined and a routine x-ray and MRI-investigation are performed. Patients must have an atraumatic degenerative supraspinatus tendon rupture comprising less than 2/3 of the tendon insertion, i.e. 1/3 of the tendon insertion must be intact. The rupture must be documented by MRI investigation. Patients must be willing and give a written informed consent. After recruitment the patients are randomized in one of three studied treatment modalities. The randomization is made after clinical and MRI investigation by neutral attendant using sealed envelopes. 60 identical envelopes (20 per group) are made in each center.

The Constant score is used as a primary outcome measure. The Constant score is measured from each patient right before treatment intervention and at three and six months, one, two and five years after the intervention. The intervention groups are designed in a cumulative fashion: structured and standardized physiotherapy treatment proceeds gradually in all patients (groups 1,2,3), in addition to physiotherapy patients in group 2 are treated with acromioplasty, and patients in group 3 with acromioplasty and rotator cuff reconstruction.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. age over 55 years
  2. atraumatic penetrating supraspinatus tendon rupture comprising less than 2/3 of the tendon insertion and documented with MRI investigation.
  3. full active range of motion
  4. written informed consent from participating subject

Exclusion Criteria:

  1. age under 55 years
  2. existing significant malignant, haematological, endocrine, metabolic, rheumatoid or gastrointestinal disease
  3. cytostatic or corticosteroid medication
  4. glenohumeral osteoarthrosis grade III or above (X-ray evaluation with present osteophytes according to Kellgren-Lawrence classification)
  5. history of alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate informed consent
  6. previous same shoulder surgery
  7. a massive tendon tear involving the whole supraspinatus tendon and/or combined tear of two - three tendons ie. supraspinatus with infraspinatus or subscapularis tendon tear.
  8. patients denial
  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: NCT01116518

Locations
Finland
Kuopio University Hospital
Kuopio, Finland, 70211
Tampere University Hospital
Tampere, Finland, 33101
Turku University Hospital
Turku, Finland, 20701
Sponsors and Collaborators
Turku University Hospital
Tampere University Hospital
Kuopio University Hospital
Investigators
Principal Investigator: Juha Kukkonen, MD Turku University Hospital
Study Director: Ville Äärimaa, MD, PhD Turku University Hospital
  More Information

No publications provided

Responsible Party: Ville Aarimaa, Ville Äärimaa, Turku University Hospital
ClinicalTrials.gov Identifier: NCT01116518     History of Changes
Other Study ID Numbers: 106/2007
Study First Received: April 29, 2010
Last Updated: November 24, 2013
Health Authority: Finland: Ethics Committee

Additional relevant MeSH terms:
Rupture
Wounds and Injuries

ClinicalTrials.gov processed this record on July 29, 2014