Treatment of Atraumatic Rotator Cuff Rupture in Elderly Patients (toarcriep)
Primary Purpose
Atraumatic Rotator Cuff Rupture
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
physiotherapy
acromioplasty
acromioplasty and rotator cuff reconstruction
Sponsored by
About this trial
This is an interventional treatment trial for Atraumatic Rotator Cuff Rupture
Eligibility Criteria
Inclusion Criteria:
- age over 55 years
- atraumatic penetrating supraspinatus tendon rupture comprising less than 2/3 of the tendon insertion and documented with MRI investigation.
- full active range of motion
- written informed consent from participating subject
Exclusion Criteria:
- age under 55 years
- existing significant malignant, haematological, endocrine, metabolic, rheumatoid or gastrointestinal disease
- cytostatic or corticosteroid medication
- glenohumeral osteoarthrosis grade III or above (X-ray evaluation with present osteophytes according to Kellgren-Lawrence classification)
- history of alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate informed consent
- previous same shoulder surgery
- 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.
- patients denial
Sites / Locations
- Kuopio University Hospital
- Tampere University Hospital
- Turku University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
physiotherapy
acromioplasty
acromioplasty and rotator cuff reconstruction
Arm Description
Outcomes
Primary Outcome Measures
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.
Constant score
subjective and objective shoulder score
Secondary Outcome Measures
Full Information
NCT ID
NCT01116518
First Posted
April 29, 2010
Last Updated
November 24, 2013
Sponsor
Turku University Hospital
Collaborators
Tampere University Hospital, Kuopio University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01116518
Brief Title
Treatment of Atraumatic Rotator Cuff Rupture in Elderly Patients
Acronym
toarcriep
Official Title
Treatment of Atraumatic Rotator Cuff Rupture in Elderly Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Turku University Hospital
Collaborators
Tampere University Hospital, Kuopio University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atraumatic Rotator Cuff Rupture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
physiotherapy
Arm Type
Active Comparator
Arm Title
acromioplasty
Arm Type
Active Comparator
Arm Title
acromioplasty and rotator cuff reconstruction
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
physiotherapy
Intervention Type
Procedure
Intervention Name(s)
acromioplasty
Intervention Type
Procedure
Intervention Name(s)
acromioplasty and rotator cuff reconstruction
Primary Outcome Measure Information:
Title
Shoulder score by Constant and Murley
Description
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.
Time Frame
2 years
Title
Constant score
Description
subjective and objective shoulder score
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age over 55 years
atraumatic penetrating supraspinatus tendon rupture comprising less than 2/3 of the tendon insertion and documented with MRI investigation.
full active range of motion
written informed consent from participating subject
Exclusion Criteria:
age under 55 years
existing significant malignant, haematological, endocrine, metabolic, rheumatoid or gastrointestinal disease
cytostatic or corticosteroid medication
glenohumeral osteoarthrosis grade III or above (X-ray evaluation with present osteophytes according to Kellgren-Lawrence classification)
history of alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate informed consent
previous same shoulder surgery
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.
patients denial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juha Kukkonen, MD
Organizational Affiliation
Turku University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ville Äärimaa, MD, PhD
Organizational Affiliation
Turku University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Kuopio University Hospital
City
Kuopio
ZIP/Postal Code
70211
Country
Finland
Facility Name
Tampere University Hospital
City
Tampere
ZIP/Postal Code
33101
Country
Finland
Facility Name
Turku University Hospital
City
Turku
ZIP/Postal Code
20701
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
Treatment of Atraumatic Rotator Cuff Rupture in Elderly Patients
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