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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Knee Arthropathy
• Intervention / Treatment: Device: knee total arthroplasty with two types of ancillaries

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.

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mike Persigant, MD; Phone Number: 02 40 08 37 78; Email: mike.persigant@chu-nanets.fr
• Study Contact Backup: Name: Ingrid Bénard; Phone Number: 0253482879; Email: ingrid.benard@chu-nantes.fr

Study Locations

• France
  • Nantes, France
    • CHU de Nantes (University Hospital of Nantes)
    • Contact: Mike Persigant, MD; Email: mike.persigant@chu-nantes.fr
    • Principal Investigator: Mike Persigant, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm A: metallic reusable ancillary.; 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; -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.
Experimental: Arm B: Efficiency single use ancillary.; 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; -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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incremental cost-utility ratio comparing single use ancillary versus reusable ancillary	Incremental cost-utility ratio comparing single use versus reused ancillaries	1 year
clinical functional result in each group (Total KSS score)	Total KSS score	1 year postoperative
clinical functional result in each arm	Total KSS score	3 months postoperative
HKA angle	HKA angle will be measured using a whole-leg radiograph (X-rays)	1 year postoperative
HKA angle	HKA angle will be measured using a whole-leg radiograph (X-rays)	3 months postoperative
Number of Adverse events in each arm	All complications related to the material or occurring in the postoperative year will be reported and compared (anemia, phlebitis, hematoma, scar disunity, scar necrosis, nosocomial infection, fracture)	1 year postoperative
Euroqol EQ-5D-5L quality-of-life questionnaire (5 questions with 5 possible answers)	Answers to EQ-5D-5L are used to calculate QALYs which represent a measure of survival weighted by health-related quality-of-life factors so that a weight of 0 represents death and a weight of 1 represents the best imaginable health status.	1 year postoperative
Euroqol EQ-5D-5L quality-of-life questionnaire (5 questions with 5 possible answers)	Answers to EQ-5D-5L are used to calculate QALYs which represent a measure of survival weighted by health-related quality-of-life factors so that a weight of 0 represents death and a weight of 1 represents the best imaginable health status.	3 months postoperative
qualitative score of surgeon's perception about ancillary (1-Excellent, 2-Good, 3- Difficult, 4- Unsure)	This qualitative score will be measured during the intervention and will include 4 levels evaluating grip and comfort; Excellent (good position in a few seconds, no doubt); Good (easy to use for the first time); Difficult (several attempts, difficult handling, uncomfortable); Unsure (persistence of doubt during use)	Day 0
weight of waste	contaminated and uncontaminated waste will be weighed at the exit of the operating room	Day 0

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Collaborators: Medacta USA
• Investigators: Principal Investigator: Mike Persigant, MD, CHU de Nantes

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2020
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: January 16, 2020
• First Submitted That Met QC Criteria: March 6, 2020
• First Posted (Actual): March 9, 2020

Study Record Updates

• Last Update Posted (Actual): March 9, 2020
• Last Update Submitted That Met QC Criteria: March 6, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: RC18_0423

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No