Official Title
Biomarkers for the Surgical Treatment of Rotator Cuff Tears
Brief Title
Biomarkers for the Surgical Treatment of Rotator Cuff Tears
Protocol ID
NCT02123784
Lead Sponsor
Balgrist University Hospital
Brief Summary
Identification of biomarkers that can predict the outcome of the surgical treatment (i.e.
the rate of re-rupture) of tears in the rotator cuff tendon.
Detailed Description
Rotator cuff tears (i.e. structural failure and tissue disruption in at least one of the
four muscles and tendons that form the rotator cuff) are extremely common injuries and
represent the most common muscle-tendon tear in patients. Repair of rotator cuff tears is
usually advocated for painful tears with functional impairment. However, high failure
rates of 13-68% have been reported for surgical repair of rotator cuff tears,
irrespective of the surgical technique employed. Higher rates of re-rupture are
associated with larger tears, increased patient age, and increased fatty degeneration of
the cuff muscles. There is no general consensus as to the causes of re-rupture; where
mechanical factors, the existing techniques of suturing, and biological factors are
considered as the main factors of recurrence.
Enrollment Count
100 participants
Eligibility Criteria
Inclusion Criteria:
- Full-thickness rotator cuff tear (isolated transmural supraspinatus muscle tear or
combined with infraspinatus and subscapularis tears) with fat content <50%
(Goutallier stage 0-2), as confirmed by magnetic resonance imaging
- Acute or chronic ruptures
- Older than 40 years of age
- Voluntary participation in this study
- Written informed consent to participate in this study
Exclusion Criteria:
- Contraindication because of ethical reasons
- Pregnant or lactating women
- Intention/wish to become pregnant during the course of this study
- Unsafe contraception
- Clinical co-morbidities, such as renal insufficiency, hepatic dysfunction,
cardiovascular disease
- Known or suspected non-adherence to the study protocol
- Smoker
- Drug or alcohol addicted
- Uncapable of following instructions, e.g. because of insufficient proficiency in
languages, psychological problems, dementia, etc.
- Participation in other clinical trials during the duration of this study, as well as
30 d before inclusion in this study
- Claustrophobia
- Systemic corticoid steroid therapy
Filters
Rotator Cuff Tears
UNKNOWN
ADULT
OLDER_ADULT