Clinical trial NCT02123784: Biomarkers for the Surgical Treatment of Rotator Cuff Tears
Official title: Biomarkers for the Surgical Treatment of Rotator Cuff Tears
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rotator Cuff Tears
Keywords: Rotator Cuff Tear
Rotator Cuff Repair
Biomarker
Predictive factors
Skeletal Muscle
Tendon
Subacromial Bursa
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
Collaborators: name: RESORTHO foundation, Forchstrasse 340, 8008 Zürich, Switzerland
First posted: 2014-04-28
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Regular patients from Balgrist University Hospital, Zurich (Switzerland)

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.

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

Primary outcomes:
measure: Changes from baseline for anatomical and functional characteristics of the ruptured rotator cuff
timeFrame: Before surgery (baseline), 3 months after surgery, 12 months after surgery
measure: Molecular and cellular characteristics of the tissues affected by tears of the rotator cuff
timeFrame: within 1 year after the last surgery
Secondary outcomes:
measure: Correlation between the molecular and cellular characteristics at the point in time of surgery, and the clinical (magnetic resonance imaging) outcomes
timeFrame: within 1 year after the last surgery
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Balgrist University Hospital
Study officials:
References: