Treatment of Atraumatic Rotator Cuff Rupture in Elderly Patients
NCT ID: NCT01116518
Last Updated: 2013-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
180 participants
INTERVENTIONAL
2009-02-28
2013-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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physiotherapy
physiotherapy
acromioplasty
acromioplasty
acromioplasty and rotator cuff reconstruction
acromioplasty and rotator cuff reconstruction
Interventions
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physiotherapy
acromioplasty
acromioplasty and rotator cuff reconstruction
Eligibility Criteria
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Inclusion Criteria
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
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
55 Years
ALL
No
Sponsors
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Tampere University Hospital
OTHER
Kuopio University Hospital
OTHER
Turku University Hospital
OTHER_GOV
Responsible Party
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Ville Aarimaa
Ville Äärimaa
Principal Investigators
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Juha Kukkonen, MD
Role: PRINCIPAL_INVESTIGATOR
Turku University Hospital
Ville Äärimaa, MD, PhD
Role: STUDY_DIRECTOR
Turku University Hospital
Locations
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Kuopio University Hospital
Kuopio, , Finland
Tampere University Hospital
Tampere, , Finland
Turku University Hospital
Turku, , Finland
Countries
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Other Identifiers
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106/2007
Identifier Type: -
Identifier Source: org_study_id