NCT04300439

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Knee Arthropathy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-03-01
• Primary completion: 2023-03-01
• Completion: 2023-03-01
• First posted: 2020-03-09
• Last updated: 2020-03-09

Locations

1 site across 1 country: France