Knee Arthropathy
Conditions
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.
Interventions
DEVICEknee 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.
Sponsors
Medacta USA
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Day 0 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| clinical functional result in each group (Total KSS score) | 1 year postoperative | Total KSS score |
| clinical functional result in each arm | 3 months postoperative | Total KSS score |
| HKA angle | 1 year postoperative | HKA angle will be measured using a whole-leg radiograph (X-rays) |
| Incremental cost-utility ratio comparing single use ancillary versus reusable ancillary | 1 year | Incremental cost-utility ratio comparing single use versus reused ancillaries |
| Euroqol EQ-5D-5L quality-of-life questionnaire (5 questions with 5 possible answers) | 1 year postoperative | 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. |
| qualitative score of surgeon's perception about ancillary (1-Excellent, 2-Good, 3- Difficult, 4- Unsure) | Day 0 | This qualitative score will be measured during the intervention and will include 4 levels evaluating grip and comfort 1. Excellent (good position in a few seconds, no doubt) 2. Good (easy to use for the first time) 3. Difficult (several attempts, difficult handling, uncomfortable) 4. Unsure (persistence of doubt during use) |
| weight of waste | Day 0 | contaminated and uncontaminated waste will be weighed at the exit of the operating room |
| Number of Adverse events in each arm | 1 year postoperative | 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) |
Countries
France
Contacts
Primary ContactMike Persigant, MD
Backup ContactIngrid Bénard
Outcome results
None listed