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The aim of this first study is to investigate in a case series through sequential sonographic imaging, using Doppler ultrasonography, the postoperative morphology, especially vascularity and findings of neovascularity, after bursa augmentation in arthroscopic rotator cuff repair.
The outcome of rotator cuff (RC) reconstruction with and without bursa augmentation, considering also the inflammatory status of the bursa, will be systematically investigated for the first time. The influencing role of the inflammatory status of the bursa, of the RC tendon and the synovial membrane at the time of the operation on the tendinous healing rate, the patient-relevant outcome factors and the revision rate will be assessed. In a further approach, basic knowledge about the role of bursa inflammation and its influence in the development and regeneration of tendon pathologies shall be gained. The findings of the whole project could lead to improve tendon healing in the reconstruction of the rotator cuff, taking advantage of augmentation potential of the subacromial bursa.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARCR-BursaSeries | Experimental | Tendon healing in the reconstruction of the rotator cuff, taking advantage of augmentation potential of the subacromial bursa. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doppler ultrasonography after bursa augmentation | Procedure | Dynamic ultrasound examination with Grading of blood vessels using the modified Ohberg Score in the longitudinal scan in dynamic ultrasound of the rotator cuff tendon - primary to surgery and 3 weeks later. |
| Measure | Description | Time Frame |
|---|---|---|
| Dynamic ultrasound examination with grading of blood vessels | using the modified Ohberg Score | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Tendon integrity | intact / partially ruptured / ruptured | 6 months |
| Tendon condition | Thickness of the repaired tendons (mm) | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Markus Scheibel, MD | Schulthess Klinik | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schulthess Klinik | Zurich | Canton of Zurich | 8008 | Switzerland |
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| D012421 | Rupture |
| D009389 | Neovascularization, Pathologic |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
| D008679 | Metaplasia |
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prospective observational case-series
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| Range of motion | Elevation (flexion), abduction, external rotation by 0° abduction, external-internal rotation by 90° abduction | 6 months |
| Shoulder muscle strength | Shoulder strength in 90° Abduction (kg) measured using a spring balance | 6 months |
| Oxford Shoulder Score (OSS) | Patient-reported Oxford Shoulder Score from 0 (worse) to 48 (best) | 6 months |
| Subjective shoulder value (SSV) | Patient-reported Subjective shoulder value from 0 (worse) to 100% (best) | 6 months |
| Constant Murley score (CMS) | Constant Murley functional score from 0 (worse) to 100 (best) | 6 months |
| Level of satisfaction | Level of satisfaction using Number Rating Scale from 0 (not satisfied) to 10 (highly satisfied) | 6 months |
| EQ-5D utilities | Patient-reported Quality of life (EuroQol EQ-5D-5L) as Utility index from 0 (worse) to 1 (best health) | 6 months |
| Adverse events | Number of patients with adverse events | 6 months |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |