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Open-label, Prospective, Multicenter, Post-market Study to Evaluate the Reverse Medacta Shoulder System of Total Shoulder Prosthesis.

NCT04431973 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-11-24

No results posted yet for this study

Summary

The goal of this study is to evaluate the performance of the Medacta Shoulder System total reverse shoulder prosthesis, at 2 years of follow up, in patients who required this prosthesis for primary omarthrosis, cuff tear arthropathy, massive cuff tear or post instability arthropathy.

The main goal is to evaluate at 2 years post-operatively the shoulder function of patients. The secondary goals are to assess the rate of complications, the survival rate of Reverse Medacta Shoulder System, the positioning of the prosthesis,pthe behaviour of the bone in contact with the humeral stem, Patient satisfaction and evolution of shoulder function in patients at 3 months and 1 year post-surgery.

Conditions

  • Shoulder Prosthesis

Interventions

DEVICE

Medacta Shoulder System

Surgical placement of the Medacta Shoulder System prothesis on patients with pathologies requiring the insertion of a total reverse shoulder prothesis for primary omarthrosis, cuff tear arthropathy, massive cuff rupture or post instability arthropathy

Sponsors & Collaborators

  • University Hospital, Tours

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2027-07-01
Completion
2027-07-01

Countries

  • France

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 NCT04431973 on ClinicalTrials.gov