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

NCT ID: NCT04300439

Last Updated: 2020-03-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-31
• Study Completion Date: 2023-03-31

Brief 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.

Detailed Description

After validation of the inclusion criteria, the surgeon will perform the randomization (1:1): single-use ancillary group or conventional ancillary group. Only the medical team and the block staff will be informed about the ancillary group, not the patient.

The use of the single-use ancillary does not induce any modification of the surgical technique for fitting a TKA. The surgical approach is unchanged and is specific to the surgeon. The appearance and use of the single-use ancillary are similar to the conventional ancillary except for the materials used for their design. Please note that a preliminary training at the beginning of the study will be carried out with the different investigators so that they can handle the different medical devices.

In total, 48 participants will be randomized. The medico-economics assessments will be performed for 20 patients (10 per group) by micro-costing to evaluate the preoperative, intraoperative and post-operative costs : reconditioning time, sterilization and transport time, preparation time and duration of intervention. The qualitative score of subjective assessment of the operator's perception of the ancillary measured during the intervention. The participants will evaluate their QOL by completing a questionnaire 3 month and 12 month postoperative. The safety parameters will also be collected.

Conditions

Knee Arthropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Arm A: metallic reusable ancillary.

This control group will be constituted of patients who will have the GMK® prosthesis with metallic reusable ancillary.

Group Type: ACTIVE_COMPARATOR

knee total arthroplasty with two types of ancillaries

Intervention Type: DEVICE

-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.

Arm B: Efficiency single use ancillary.

This group will be constituted of patients who will have the GMK® prosthesis with Efficiency single use ancillary.

Group Type: EXPERIMENTAL

knee total arthroplasty with two types of ancillaries

Intervention Type: DEVICE

-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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patient with gonarthrosis or inflammatory arthrosis of the knee leading to surgical indication for total knee arthroplasty
• Informed patient, able to understand the information, not opposing to participate this protocol
• patient affiliate to social security

Exclusion Criteria

• Extra-joint Deformation needing bone associated gesture
• Preoperative active or suspected infection
• Local evolutive tumoral pathology
• Medical history with bone gesture on concerned knee
• Patient unable or refusing to give his consentement
• Pregnant woman or in age to be pregnant without use any effective contraceptive method
• Patient under maintenance of justice, tutelage or legal guardianship)
• Presence of any family, sociological, political or geographic situation able to interfere with the protocol

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medacta USA

INDUSTRY

Sponsor Role: collaborator

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mike Persigant, MD

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

CHU de Nantes (University Hospital of Nantes)

Nantes, , France

Countries

France

Central Contacts

Mike Persigant, MD

Role: CONTACT

mike.persigant@chu-nanets.fr

02 40 08 37 78

Ingrid Bénard

Role: CONTACT

ingrid.benard@chu-nantes.fr

0253482879

Facility Contacts

Mike Persigant, MD

Role: primary

mike.persigant@chu-nantes.fr

Other Identifiers

RC18_0423

Identifier Type: -

Identifier Source: org_study_id