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

University Hospital, Clermont-Ferrand

Status: Completed

Conditions: Total Hip Replacement; Coxarthrosis

Treatments: Device: total hip replacement with single use ancillary; Device: total hip replacement with conventional ancillary

Study type: Interventional

Funder types: Other

Identifiers

NCT04903860

2021-A00363-38 (Other Identifier)

RBHP 2021 ERIVAN

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• • Patient, male or female, over 18 years of age, eligible for a first-line total hip replacement for isolated coxarthrosis
• Patient registered to the national health system
• Patient able to understand information about the protocol and answer to questionnaire

Exclusion criteria

• Pregnant, breastfeeding or potentially pregnant woman
• Major disability
• History of hip replacement surgery
• Any surgical and/or anesthetic contraindication, or any condition deemed by the investigator to be incompatible with the research.
• Morbid obesity as defined by body mass index (BMI) >40 kg.m-2
• History of recent infection at the surgical site
• Surgical contraindication
• Refusal to participate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Single use reamers

Active Comparator group

Description:

Total hip replacement with the use of disposable reamers

Treatment:

Device: total hip replacement with single use ancillary

conventional ancillary

Active Comparator group

Description:

Total hip replacement with the use of conventional reamers

Treatment:

Device: total hip replacement with conventional ancillary