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Hemiverse Shoulder Prosthesis

NCT04701268 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2024-08-27

No results posted yet for this study

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 do not qualify for a regular reverse or hemi-prosthesis due to severe medical conditions, poor bone stock or critical status of the rotator cuff. The expected benefit is, that patients will have a minimally invasive surgical procedure, only addressing the humeral shaft, however with the biomechanical advantage of a total reverse shoulder prosthesis, meaning, that with a minimally invasive surgery a comparable result as with a regular total shoulder prosthesis is accomplished. Patients will be closely monitored within the study protocol for 24 months and thereafter in regular interval as with a normal prosthetic follow-up.

Conditions

  • Rotator Cuff Tears
  • Hemiarthroplasty

Interventions

OTHER

Device: Hemiverse

Implantation of the hemiverse shoulder prothesis

Sponsors & Collaborators

  • Cantonal Hospital of St. Gallen

    collaborator OTHER

  • 41Hemiverse AG

    lead INDUSTRY

Principal Investigators

  • Bernhard Jost, MD · Klinik für Orthopädische Chirurgie und Traumatologie des Bewegungsapparates

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-15
Primary Completion
2024-06-24
Completion
2024-06-24

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04701268 on ClinicalTrials.gov