Status:
TERMINATED
Hemiverse Shoulder Prosthesis
Lead Sponsor:
41Hemiverse AG
Collaborating Sponsors:
Cantonal Hospital of St. Gallen
Conditions:
Rotator Cuff Tears
Hemiarthroplasty
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
This clinical trial investigates the safety and the preliminary clinical benefit of the hemiverse shoulder prosthesis. Implantation of this newly developed hemi-prosthesis is intended for patients who...
Detailed Description
This clinical trial investigates the safety and the preliminary clinical benefit of the hemiverse shoulder prosthesis. Implantation of this newly developed hemi-prosthesis is intended for patients who...
Eligibility Criteria
Inclusion
- Patients aged ≥40 years
- Cuff failure with associated shoulder destruction which would be suited for hemiarthoplasty
- Shoulder joint destruction in which known alternatives would constitute either a high patient risk or a high functional failure risk.
- Shoulder destruction for which reverse total shoulder replacement would be a high risk for medical reasons (longer operation, more blood loss) or for advanced glenoid bone destruction
- Written informed consent
Exclusion
- Systemic contraindication according to internal medical and anesthesiological standards (e.g. Renal disease, Cardiopulmonary Disease, Heart Disease, Medication including Anticoagulation, Poorly controlled diabetes mellitus, Immunosuppressive drugs etc)
- Neuroarthropathy
- Moderate to severe motor axillary nerve dysfunction
- Moderate to severe destruction of deltoid muscle
- Fracture of the scapular spine or displaced fracture of the basis of the acromion
- Fracture of the base of the coracoid
- Destruction of more than superior one third of the humeral shaft
- Chronic inflammatory diseases,which the PI estimates contribute to a higher risk of surgery complications
- Inability to cooperate with postoperative regimen or to understand the trial information
- Impaired judgement
Key Trial Info
Start Date :
July 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 24 2024
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04701268
Start Date
July 15 2021
End Date
June 24 2024
Last Update
August 27 2024
Active Locations (1)
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1
Kantonsspital St. Gallen, Klinik für Orthopädische Chirurgie und Traumatologie des Bewegungsapparates
Sankt Gallen, Canton of St. Gallen, Switzerland, 9007