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NCT03924063: Hemiverse

Safety of the Hemiverse Shoulder Prothesis

Withdrawn NA Last updated 15 March 2023
What this trial tests

NA trial testing Hemiverse in Rotator Cuff Tear. Withdrawn.

Timeline
14 May 2021
Primary endpoint
14 May 2021
14 May 2021

Quick facts

Lead sponsorBalgrist University Hospital
PhaseNA
StatusWithdrawn
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Start date14 May 2021
Primary completion14 May 2021
Estimated completion14 May 2021
Sites1 location across Austria

Drugs / interventions tested

Conditions studied

Sponsor

Balgrist University Hospital

Who can join

65 and older, any sex, with Rotator Cuff Tear or Hemiarthroplasty. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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 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 18 months and thereafter in regular interval was as with a normal prosthetic followup.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Rotator Cuff Tear

Currently open trials in the same condition.

Other Balgrist University Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03924063.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing