Biomarkers for the Surgical Treatment of Rotator Cuff Tears (MARK-GEROT)

Balgrist University Hospital

Status: Unknown

Conditions: Rotator Cuff Tears

Study type: Observational

Funder types: Other

Identifiers

NCT02123784

W 522 MARK GEROT

KEK-ZH-Nr. 2013-0352 (Other Identifier)

Details and patient eligibility

About

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.

Full 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: 100 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

Rotator cuff tear

Description:

Patients which demonstrate a full-thickness tear of the rotator cuff tendon and meet the inclusion criteria.