Treatment of Atraumatic Rotator Cuff Rupture in Elderly Patients (toarcriep)
Recruitment status was Recruiting
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.
Atraumatic Rotator Cuff Rupture
Procedure: acromioplasty and rotator cuff reconstruction
|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|
- 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
|Study Start Date:||February 2009|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
|Active Comparator: physiotherapy||Procedure: physiotherapy|
|Active Comparator: acromioplasty||Procedure: acromioplasty|
|Active Comparator: acromioplasty and rotator cuff reconstruction||Procedure: acromioplasty and rotator cuff reconstruction|
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.
|Contact: Ville Äärimaa, MD, PhD||+358 (0)2 firstname.lastname@example.org|
|Contact: Juha Kukkonen, MD||+358 (0)2 email@example.com|
|Kuopio University Hospital||Recruiting|
|Kuopio, Finland, 70211|
|Contact: Antti Joukainen, MD, PhD +358 0(17) 173311 firstname.lastname@example.org|
|Tampere University Hospital||Recruiting|
|Tampere, Finland, 33101|
|Contact: Janne Lehtinen, MD,PhD +358 (0)3 565713 email@example.com|
|Turku University Hospital||Recruiting|
|Turku, Finland, 20701|
|Contact: Juha Kukkonen, MD +358 (0)2 3130000 firstname.lastname@example.org|
|Principal Investigator:||Juha Kukkonen, MD||Turku University Hospital|
|Study Director:||Ville Äärimaa, MD, PhD||Turku University Hospital|