Atraumatic Rotator Cuff Rupture Clinical Trial
Official title:
Treatment of Atraumatic Rotator Cuff Rupture in Elderly Patients
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, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment