Treatment of Atraumatic Rotator Cuff Rupture in Elderly Patients

Atraumatic Rotator Cuff Rupture Clinical Trial

— toarcriep  

Official title:

Treatment of Atraumatic Rotator Cuff Rupture in Elderly Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01116518
• Other study ID #: 106/2007
• Status: Completed
• Phase: N/A
• First received: April 29, 2010
• Last updated: November 24, 2013
• Start date: February 2009
• Est. completion date: November 2013

Study information

• Verified date: May 2010
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

1. age over 55 years

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:

1. age under 55 years

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atraumatic Rotator Cuff Rupture
• Rupture

Intervention

Procedure:
• physiotherapy

• acromioplasty

• acromioplasty and rotator cuff reconstruction

Locations

Country	Name	City	State
Finland	Kuopio University Hospital	Kuopio
Finland	Tampere University Hospital	Tampere
Finland	Turku University Hospital	Turku

Sponsors (3)

Lead Sponsor	Collaborator
Turku University Hospital	Kuopio University Hospital, Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder score by Constant and Murley	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.	2 years	No
Primary	Constant score	subjective and objective shoulder score		No