Clinical trial NCT04300439: Medico-economic Interest of Single-use Ancillary Efficiency® in Fitting a GMK® Total Knee Arthroplasty (TKA)
Official title: Medico-economic Interest of Single-use Ancillary Efficiency® in Fitting a GMK® Total Knee Arthroplasty (TKA)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Arthropathy
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: Medacta USA
First posted: 2020-03-09
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: 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
timeFrame: Day 0
Secondary outcomes:
measure: Incremental cost-utility ratio comparing single use ancillary versus reusable ancillary
timeFrame: 1 year
measure: clinical functional result in each group (Total KSS score)
timeFrame: 1 year postoperative
measure: clinical functional result in each arm
timeFrame: 3 months postoperative
measure: HKA angle
timeFrame: 1 year postoperative
measure: HKA angle
timeFrame: 3 months postoperative
measure: Number of Adverse events in each arm
timeFrame: 1 year postoperative
measure: Euroqol EQ-5D-5L quality-of-life questionnaire (5 questions with 5 possible answers)
timeFrame: 1 year postoperative
measure: Euroqol EQ-5D-5L quality-of-life questionnaire (5 questions with 5 possible answers)
timeFrame: 3 months postoperative
measure: qualitative score of surgeon's perception about ancillary (1-Excellent, 2-Good, 3- Difficult, 4- Unsure)
timeFrame: Day 0
measure: weight of waste
timeFrame: Day 0
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes (University Hospital of Nantes)
Study officials:
affiliation: Nantes University Hospital
name: Mike Persigant, MD
role: PRINCIPAL_INVESTIGATOR
References: