NCT04903860

Comparison of the Use of Conventional Ancillary Reaming and Single-use Ancillary Reaming Material in Total Hip Replacement

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective of the study is to compare the use of single-use ancillary reaming material during total hip replacement and conventional reusable ancillary reaming material. The assessment will focus on the medico-economic differences found in this prospective randomized study

Detailed description

In orthopaedics, the ancillary equipment is a generic term that includes all the instruments necessary for hip replacement surgery. The surgeon remains very dependent on these boxes of instruments, including rasps, reamers and trial implants (stems and trial heads), which are required in THR. Each instrument set is generally packaged in 2 or 3 boxes and each surgeon has a limited number of instrument sets at his disposal per operating day. Each ancillary device has a purchase cost, a maintenance cost (paid by the laboratories or distributors) and a sterilization cost, (paid by the health care institutions). Single-use reamers are instruments that are used on a single patient and then discarded. Performance and safety of use are optimized by providing a sterile and new product for each use. Therefore, it seems judicious to compare the medico-economic differences between the use of single-use reamers versus reusable reamers within a classic ancillary. This study will compare the costs incurred, the waste produced, the operating time, the satisfaction of the surgeon after the use of single-use reamers during total hip replacement, versus conventional re-sterilizable ancillary and verify the equivalence, three months after surgery, of clinical and radiological results.

Conditions

• Total Hip Replacement
• Coxarthrosis

Interventions

Type	Name	Description
DEVICE	total hip replacement with single use ancillary	Comparison of the use of conventional ancillary reaming and single-use ancillary reaming material in total hip replacement
DEVICE	total hip replacement with conventional ancillary	Comparison of the use of conventional ancillary reaming and single-use ancillary reaming material in total hip replacement

Timeline

• Start date: 2021-07-12
• Primary completion: 2022-07-27
• Completion: 2022-07-27
• First posted: 2021-05-27
• Last updated: 2022-07-28

Locations

1 site across 1 country: France