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

NCT04300439 | Unknown

• 1 other identifier: RC18_0423
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Arthropathy

Outcome Measures

Primary Outcomes (1)

• Mean production cost of the surgical intervention (total knee arthroplasty) each arm, from an hospital perspective, using a micro-costing approach with items reported in a eCRF

  Mean production cost of the surgical intervention in each arm is calculated thanks to 2 steps : 1) Quantification of health resources consumed during the surgical intervention (transport, cleaning, reconditionning sterilization of ancillaries, time spent by medical staff, nurses and materials used. (These data will be collected on a paper sheet and reported in a eCRF for 20 patients (10 per group)) ; 2) Valuation of health resources consumed with hospital cost accounting, mean wages, and purchase prices of materials.

  Day 0

Secondary Outcomes (10)

• Incremental cost-utility ratio comparing single use ancillary versus reusable ancillary

  1 year

• clinical functional result in each group (Total KSS score)

  1 year postoperative

• clinical functional result in each arm

  3 months postoperative

• HKA angle

  1 year postoperative

• HKA angle

  3 months postoperative

Study Arms (2)

Arm A: metallic reusable ancillary.

ACTIVE COMPARATOR

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

Device: knee total arthroplasty with two types of ancillaries

Arm B: Efficiency single use ancillary.

EXPERIMENTAL

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

Device: knee total arthroplasty with two types of ancillaries

Interventions

knee total arthroplasty with two types of ancillaries 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 A: metallic reusable ancillary.; Arm B: Efficiency single use ancillary.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead
• Medacta USA: collaborator

Study Sites (1)

CHU de Nantes (University Hospital of Nantes)

Nantes, France

Location

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Mike Persigant, MD

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mike Persigant, MD

CONTACT

02 40 08 37 78; mike.persigant@chu-nanets.fr

Ingrid Bénard

CONTACT

0253482879; ingrid.benard@chu-nantes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: March 9, 2020
• Study Start: March 1, 2020
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: March 9, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)