An interventional study of knee total arthroplasty with two types of ancillaries in Knee Arthropathy, sponsored by Nantes University Hospital. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-09.
Sponsored by Nantes University Hospital · Not applicable, Interventional, and Other
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.
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.
712 studies on the registry are indexed under Joint Diseases; 127 are open to participants now.
This study's planned enrollment of 48 is below the median of 60 across 470 interventional studies indexed under Joint Diseases.
Browse Joint Diseases studies →Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
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.
Time frame: Day 0
Incremental cost-utility ratio comparing single use ancillary versus reusable ancillary
Incremental cost-utility ratio comparing single use versus reused ancillaries
Time frame: 1 year
clinical functional result in each group (Total KSS score)
Total KSS score
Time frame: 1 year postoperative
clinical functional result in each arm
Total KSS score
Time frame: 3 months postoperative
HKA angle
HKA angle will be measured using a whole-leg radiograph (X-rays)
Time frame: 1 year postoperative
HKA angle
HKA angle will be measured using a whole-leg radiograph (X-rays)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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 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)
Time frame: Day 0
weight of waste
contaminated and uncontaminated waste will be weighed at the exit of the operating room
Time frame: Day 0
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Nantes University Hospital