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Effectiveness of Hemi- Versus Total Shoulder Arthroplasty Using Implants of the "Epoca" System

NCT01288066 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2024-07-01

No results posted yet for this study

Summary

The clinical question on whether or not to replace the glenoid component in patients with a degenerative shoulder disease, has not been answered yet in a randomized study with enough statistical power. In this study, patients are randomly allocated to a treatment with a hemi- or total shoulder arthroplasty using implants of the Epoca system. The primary objective is the comparison of pain and function between the treatment groups after 5 years using the Constant score.

Conditions

Interventions

PROCEDURE

Hemiarthroplasty

Patients are treated with hemi shoulder arthroplasty with CE marked medical devices of the Epoca system. This procedure is a standard treatment for patients with a degenerative shoulder disease.

PROCEDURE

Total arthroplasty

Patients are treated with total shoulder arthroplasty with CE marked medical devices of the Epoca system. This procedure is a standard treatment for patients with a degenerative shoulder disease.

Sponsors & Collaborators

  • Synthes GmbH

    collaborator INDUSTRY

  • AO Innovation Translation Center

    lead OTHER

Principal Investigators

  • Norbert Suedkamp, MD · Universitätsklinikum Freiburg, Deutschland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • Austria
  • Germany
  • Sweden

Study Locations

More Related Trials

Entities

Diseases

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 NCT01288066 on ClinicalTrials.gov