Treatment of Atraumatic Rotator Cuff Rupture in Elderly Patients
toarcriep
1 other identifier
interventional
180
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2009
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 29, 2010
CompletedFirst Posted
Study publicly available on registry
May 5, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedNovember 26, 2013
May 1, 2010
4.8 years
April 29, 2010
November 24, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
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
Constant score
subjective and objective shoulder score
Study Arms (3)
physiotherapy
ACTIVE COMPARATORacromioplasty
ACTIVE COMPARATORacromioplasty and rotator cuff reconstruction
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Turku University Hospitallead
- Tampere University Hospitalcollaborator
- Kuopio University Hospitalcollaborator
Study Sites (3)
Kuopio University Hospital
Kuopio, 70211, Finland
Tampere University Hospital
Tampere, 33101, Finland
Turku University Hospital
Turku, 20701, Finland
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Juha Kukkonen, MD
Turku University Hospital
- STUDY DIRECTOR
Ville Äärimaa, MD, PhD
Turku University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ville Äärimaa
Study Record Dates
First Submitted
April 29, 2010
First Posted
May 5, 2010
Study Start
February 1, 2009
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
November 26, 2013
Record last verified: 2010-05