- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02123784
Biomarkers for the Surgical Treatment of Rotator Cuff Tears (MARK-GEROT)
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Zurich, Switzerland, 8008
- Recruiting
- Balgrist University Hospital
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Contact:
- Martin Flück, PhD
- Phone Number: 3791 +41 44 386
- Email: mflueck@research.balgrist.ch
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Contact:
- Marco Toigo, PhD
- Phone Number: 3794 +41 44 386
- Email: mtoigo@research.balgrist.ch
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Principal Investigator:
- Christian Gerber, MD FRCS(Ed)
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Sub-Investigator:
- Dominik Meyer, MD
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Sub-Investigator:
- Karl Wieser, MD
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Principal Investigator:
- Martin Flück, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Rotator cuff tear
Patients which demonstrate a full-thickness tear of the rotator cuff tendon and meet the inclusion criteria.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes from baseline for anatomical and functional characteristics of the ruptured rotator cuff
Time Frame: Before surgery (baseline), 3 months after surgery, 12 months after surgery
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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.
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Before surgery (baseline), 3 months after surgery, 12 months after surgery
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Molecular and cellular characteristics of the tissues affected by tears of the rotator cuff
Time Frame: within 1 year after the last surgery
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between the molecular and cellular characteristics at the point in time of surgery, and the clinical (magnetic resonance imaging) outcomes
Time Frame: within 1 year after the last surgery
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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.
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within 1 year after the last surgery
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- W 522 MARK GEROT
- KEK-ZH-Nr. 2013-0352 (Other Identifier: Ethics Committee of the Canton Zurich, Switzerland)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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