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Medico-economic Interest of Single-use Ancillary Efficiency® in Fitting a GMK® Total Knee Arthroplasty (TKA)

NCT04300439 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2020-03-09

No results posted yet for this study

Summary

Clinical studies on single-use ancillaries are still few; medico-economic benefits have to be assessed regarding their design and use.

A foreseeable increase in the number of surgeries in the future, tends to change the techniques and consequently to question the medico-economic context. Single-use ancillaries attempt to provide solutions to today's imperatives and could be relevant from a global medico-economic point of view.

For the moment, the conventional ancillaries for TKA are reused after sterilization.

The objective of the study is to improve the fluidity of the intervention process with cost control.

Conditions

  • Knee Arthropathy

Interventions

DEVICE

knee total arthroplasty with two types of ancillaries

-For the Arm A, the surgical procedure of knee total arthroplasty will be done with metallic reusable ancillary. For the Arm B, the surgical procedure of knee total arthroplasty will be done with Efficiency single use ancillary.

Sponsors & Collaborators

  • Medacta USA

    collaborator INDUSTRY

  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • Mike Persigant, MD · Nantes University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-31
Primary Completion
2023-03-31
Completion
2023-03-31

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 NCT04300439 on ClinicalTrials.gov