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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.
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.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Atraumatic Rotator Cuff Rupture
physiotherapy, acromioplasty, acromioplasty and rotator cuff reconstruction
Kuopio University Hospital
Turku University Hospital
Published on BioPortfolio: 2014-07-24T14:05:52-0400
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