Rotator Cuff TearsMARK-GEROTNCT02123784
Biomarkers for the Surgical Treatment of Rotator Cuff Tears
An observational study of Rotator Cuff Tears, run by Balgrist University Hospital at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Rotator Cuff Tears
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2014to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Regular patients from Balgrist University Hospital, Zurich (Switzerland)
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Balgrist University Hospital
Zurich, 8008
Martin Flück, PhD, +41 44 386 ext. 3791, mflueck@research.balgrist.ch
Marco Toigo, PhD, +41 44 386 ext. 3794, mtoigo@research.balgrist.ch
About this study
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.
Read the 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
- Keywords
- Rotator Cuff Tear, Rotator Cuff Repair, Biomarker, Predictive factors, Skeletal Muscle, Tendon, Subacromial Bursa
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Rotator cuff tear | Patients which demonstrate a full-thickness tear of the rotator cuff tendon and meet the inclusion criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before surgery (baseline), 3 months after surgery, 12 months after surgery
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).
Measured: within 1 year after the last surgery
Secondary outcomes (1)
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.
Measured: within 1 year after the last surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- RESORTHO foundation, Forchstrasse 340, 8008 Zürich, Switzerland
- Responsible party
- Principal investigator, Professor Martin Flück, Balgrist University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02123784
- Sponsor's protocol ID
- W 522 MARK GEROT
- Other IDs
- KEK-ZH-Nr. 2013-0352
- Acronym
- MARK-GEROT
- Status last verified
- Jul 2016
- First submitted
- 14 Apr 2014
- Last updated
- 4 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 37736603
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers for the Surgical Treatment of Rotator Cuff Tears
- ClinicalTrials.gov ID
- NCT02123784
- Acronym / sponsor ID
- MARK-GEROT / W 522 MARK GEROT
- Conditions
- Rotator Cuff Tears
- Keywords
- Rotator Cuff Tear, Rotator Cuff Repair, Biomarker, Predictive factors, Skeletal Muscle, Tendon, Subacromial Bursa
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Collaborators
- RESORTHO foundation, Forchstrasse 340, 8008 Zürich, Switzerland
- Study start
- Apr 2014
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 28 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rotator cuff tear | – | –Patients which demonstrate a full-thickness tear of the rotator cuff tendon and meet the inclusion criteria. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Regular patients from Balgrist University Hospital, Zurich (Switzerland)
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
Molecular and cellular characteristics of the tissues affected by tears of the rotator cuff
Time frame: within 1 year after the last surgery
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).
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2016.
- Derived from this study: PubMed 37736603Olthof 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Tears, run by Balgrist University Hospital at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02123784, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2016.