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| ID | Type | Description | Link |
|---|---|---|---|
| KEK-ZH-Nr. 2013-0352 | Other Identifier | Ethics Committee of the Canton Zurich, Switzerland |
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| Name | Class |
|---|---|
| RESORTHO foundation, Forchstrasse 340, 8008 Zürich, Switzerland | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rotator cuff tear | Patients which demonstrate a full-thickness tear of the rotator cuff tendon and meet the inclusion criteria. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 | 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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Inclusion Criteria:
Exclusion Criteria:
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Regular patients from Balgrist University Hospital, Zurich (Switzerland)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Balgrist University Hospital | Recruiting | Zurich | 8008 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37736603 | Derived | 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. |
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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blood, muscle, tendon, capsule, synovial liquid
| within 1 year after the last surgery |