Biomarkers for the Surgical Treatment of Rotator Cuff Tears

Rotator Cuff Tears Clinical Trial

— MARK-GEROT  

Official title:

Biomarkers for the Surgical Treatment of Rotator Cuff Tears

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02123784
• Other study ID #: W 522 MARK GEROT
• Secondary ID: KEK-ZH-Nr. 2013-
• Status: Recruiting
• Phase: N/A
• First received: April 14, 2014
• Last updated: July 1, 2016
• Start date: April 2014
• Est. completion date: December 2017

Study information

• Verified date: July 2016
• Source: Balgrist University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Federal Office of Public Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Rotator Cuff Tears

Locations

Country	Name	City	State
Switzerland	Balgrist University Hospital	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
Balgrist University Hospital	RESORTHO foundation, Forchstrasse 340, 8008 Zürich, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline for anatomical and functional characteristics of the ruptured rotator cuff	Patients will undergo a clinical and functional examination which includes the assessment of mobility, pain and abduction force of the affected and healthy shoulder using standardized tests (Constant score, Quick DASH, Quality of Life Score SF-12), the quantification of the volume (cm3) and fat content (Goutallier Stage) of the affected shoulder using magnet resonance imaging.	Before surgery (baseline), 3 months after surgery, 12 months after surgery	No
Primary	Molecular and cellular characteristics of the tissues affected by tears of the rotator cuff	Before the surgery 10 mL of venous blood will be drawn from the patients and processed for the isolation of genomic DNA and the measure of selected single nuclear polymorphisms.; Biopsies (~10 mg) will be collected intra-operatively from the affected muscle, tendon, capsule and synovial liquid and stored at -80°C. Samples will be subjected to the immunohistochemical and biochemical quantification of the content (in arbitrary units) of selected proteins and tissue composition (as % of total volume).	within 1 year after the last surgery	No
Secondary	Correlation between the molecular and cellular characteristics at the point in time of surgery, and the clinical (magnetic resonance imaging) outcomes	The relationship of the molecular and cellular parameters (measured as primary endpoints) of affected muscle with the clinical and functional measures of shoulder function will be investigated using Pearson correlation and mutual information analysis.	within 1 year after the last surgery	No