Knee Arthropathy Clinical Trial
— IMEDUUOfficial title:
Medico-economic Interest of Single-use Ancillary Efficiency® in Fitting a GMK® Total Knee Arthroplasty (TKA)
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.
Status | Not yet recruiting |
Enrollment | 48 |
Est. completion date | March 2023 |
Est. primary completion date | March 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | CHU de Nantes (University Hospital of Nantes) | Nantes |
Lead Sponsor | Collaborator |
---|---|
Nantes University Hospital | Medacta USA |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Incremental cost-utility ratio comparing single use ancillary versus reusable ancillary | Incremental cost-utility ratio comparing single use versus reused ancillaries | 1 year | |
Secondary | clinical functional result in each group (Total KSS score) | Total KSS score | 1 year postoperative | |
Secondary | clinical functional result in each arm | Total KSS score | 3 months postoperative | |
Secondary | HKA angle | HKA angle will be measured using a whole-leg radiograph (X-rays) | 1 year postoperative | |
Secondary | HKA angle | HKA angle will be measured using a whole-leg radiograph (X-rays) | 3 months postoperative | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | weight of waste | contaminated and uncontaminated waste will be weighed at the exit of the operating room | Day 0 |
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