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

University Hospital, Clermont-Ferrand40 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Total Hip Replacement Coxarthrosis

Interventions

total hip replacement with single use ancillaryDEVICE

Comparison of the use of conventional ancillary reaming and single-use ancillary reaming material in total hip replacement

total hip replacement with conventional ancillaryDEVICE

Comparison of the use of conventional ancillary reaming and single-use ancillary reaming material in total hip replacement

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

CHU clermont-ferrand

Clermont-Ferrand, France

Outcomes

Primary Outcomes

Overall cost of surgery

Direct medical costing in both groups: * Sterilization costs, * Inventory management costs, * Material costs, * Waste management costs, * Operating room costs based on room occupancy times.

Time frame: At 3 months

Secondary Outcomes

Surgical time

Calculated from the beginning of the skin incision to closure and recorded on the anesthesia sheet

Time frame: intraoperative

Modified Merle d'Aubigné and Postel Method score

The patients were evaluated by the Modified Merle d'Aubigné and Postel Method, which evaluates pain, gait and mobility, on a scale of 1 to 6 for each item, where 1 indicates the worst and 6, the best state of the patient. The total minimum score reached is 3, and the maximum is 18.

Time frame: Pré-opérative examination / At 3 months

Harris Hip Score

This instrument has 10 items in 3 sections describing pain, function, range of motion, and deformity. The first section is questionnaire-based, answered by the patient, and includes impairments and activities. The second and third sections are administered by the therapist or physician, and include leg length measurement and range of motion (ROM) measures of the hip (flexion, abduction, external rotation and adduction). Each item has a unique numerical scale that corresponds to descriptive response options. The highest possible score is 100, with a higher score indicating less dysfunction.

Time frame: Pré-opérative examination / At 3 months

Charnley classification and Devane score

Devane score: The purpose of this score is to specify the patient's activity level preoperatively. Initially established by Devane, it allows a classification of each patient in 5 categories from sedentary to athletic Charnley score: This is a commonly used score designed to assess the patient's overall disability in relation to gait function. It was published by Charnley and distinguishes patients into 3 categories

Data from ClinicalTrials.gov

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