Biomarkers for the Surgical Treatment of Rotator Cuff Tears

NCT ID: NCT02123784

Last Updated: 2016-07-04

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2017-12-31

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.

Conditions

Rotator Cuff Tears

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Rotator cuff tear

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

No interventions assigned to this group

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RESORTHO foundation, Forchstrasse 340, 8008 Zürich, Switzerland

UNKNOWN

Sponsor Role: collaborator

Balgrist University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Professor Martin Flück

Professor for Muscle Plasticity

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Balgrist University Hospital

Zurich, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Facility Contacts

Martin Flück, PhD

Role: primary

mflueck@research.balgrist.ch

+41 44 386 ext. 3791

Marco Toigo, PhD

Role: backup

mtoigo@research.balgrist.ch

+41 44 386 ext. 3794

References

Olthof MGL, Fluck M, Borbas P, Valdivieso P, Toigo M, Egli F, Joshy J, Filli L, Snedeker JG, Gerber C, Wieser K. Structural Musculotendinous Parameters That Predict Failed Tendon Healing After Rotator Cuff Repair. Orthop J Sports Med. 2023 Sep 19;11(9):23259671231196875. doi: 10.1177/23259671231196875. eCollection 2023 Sep.

Reference Type: DERIVED

PMID: 37736603 (View on PubMed)

Other Identifiers

KEK-ZH-Nr. 2013-0352

Identifier Type: OTHER

Identifier Source: secondary_id

W 522 MARK GEROT

Identifier Type: -

Identifier Source: org_study_id