Treatment of Atraumatic Rotator Cuff Rupture in Elderly Patients (toarcriep)
|ClinicalTrials.gov Identifier: NCT01116518|
Recruitment Status : Completed
First Posted : May 5, 2010
Last Update Posted : November 26, 2013
|Condition or disease||Intervention/treatment||Phase|
|Atraumatic Rotator Cuff Rupture||Procedure: physiotherapy Procedure: acromioplasty Procedure: acromioplasty and rotator cuff reconstruction||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Atraumatic Rotator Cuff Rupture in Elderly Patients|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2013|
|Active Comparator: physiotherapy||Procedure: physiotherapy|
|Active Comparator: acromioplasty||Procedure: acromioplasty|
|Active Comparator: acromioplasty and rotator cuff reconstruction||Procedure: acromioplasty and rotator cuff reconstruction|
- Shoulder score by Constant and Murley [ Time Frame: 2 years ]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 scoresubjective and objective shoulder score
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01116518
|Kuopio University Hospital|
|Kuopio, Finland, 70211|
|Tampere University Hospital|
|Tampere, Finland, 33101|
|Turku University Hospital|
|Turku, Finland, 20701|
|Principal Investigator:||Juha Kukkonen, MD||Turku University Hospital|
|Study Director:||Ville Äärimaa, MD, PhD||Turku University Hospital|