NCT02123784

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 28, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

July 4, 2016

Status Verified

July 1, 2016

Enrollment Period

3.2 years

First QC Date

April 14, 2014

Last Update Submit

July 1, 2016

Conditions

Rotator Cuff Tears

Keywords

Rotator Cuff TearRotator Cuff RepairBiomarkerPredictive factorsSkeletal MuscleTendonSubacromial Bursa

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (1)

  • Correlation between the molecular and cellular characteristics at the point in time of surgery, and the clinical (magnetic resonance imaging) outcomes

    within 1 year after the last surgery

Study Arms (1)

Rotator cuff tear

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

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Regular patients from Balgrist University Hospital, Zurich (Switzerland)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • Claustrophobia
  • Systemic corticoid steroid therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Balgrist University Hospital

Zurich, 8008, Switzerland

RECRUITING

Related Publications (1)

  • 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.

    PMID: 37736603DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood, muscle, tendon, capsule, synovial liquid

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor for Muscle Plasticity

Study Record Dates

First Submitted

April 14, 2014

First Posted

April 28, 2014

Study Start

April 1, 2014

Primary Completion

June 1, 2017

Study Completion

December 1, 2017

Last Updated

July 4, 2016

Record last verified: 2016-07

Locations

CH(1)