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

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

Study Overview

• Status: Completed
• Conditions: Total Hip Replacement; Coxarthrosis
• Intervention / Treatment: Device: total hip replacement with single use ancillary; Device: total hip replacement with conventional ancillary

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France
    • CHU Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Single use reamers; Total hip replacement with the use of disposable reamers	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
Active Comparator: conventional ancillary; Total hip replacement with the use of conventional reamers	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical time	Calculated from the beginning of the skin incision to closure and recorded on the anesthesia sheet	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.	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.	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	Pré-opérative examination / At 3 months
WOMAC score	The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of hip, including five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68).	Pré-opérative examination / At 3 months
HOOS score	The hip disability and osteoarthritis outcome score (HOOS) is a questionnaire intended to be used to assess the patient's opinion about their hip and associated problems and to evaluate symptoms and functional limitations related to the hip during a therapeutic process. To interpret the score, the outcome measure is transformed in a worst to best scale from 0 to 100, with 100 indicating no symptoms and 0 indicating extreme symptoms.	Pré-opérative examination / At 3 months
Pain evaluation	The visual similar scale is auto completed. For the intensity of pain, the scale varies between "no pain" (the score of 0) and "most painful" (the score of 10).	Pré-opérative examination / At 3 months
Operator satisfaction	Operator satisfaction score (numerical scale from 0 (not satisfied) to 10 (very satisfied)) of the material during the surgical procedure	through surgical intervention an average of 1 day
Radiological analysis	realization of standard radiographs of the pelvis from the front, hip from the front and from the side. Analysis of the acetabulum according to Charnley and search for the presence of granulometry, migration or acetabular osteolysis. Measurement of the femoral and acetabular offset and height of the center of rotation	At 3 months
Complications	Analysis of possible intraoperative and postoperative complications and their costs: loosening, infection, dislocation, wear and implant fracture	At 3 months

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: Groupe Lépine
• Investigators: Principal Investigator: Roger ERIVAN, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2021
• Primary Completion (Actual): July 27, 2022
• Study Completion (Actual): July 27, 2022

Study Registration Dates

• First Submitted: May 12, 2021
• First Submitted That Met QC Criteria: May 25, 2021
• First Posted (Actual): May 27, 2021

Study Record Updates

• Last Update Posted (Actual): July 28, 2022
• Last Update Submitted That Met QC Criteria: July 27, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Prospective; Randomized study; Sterilization; Medico-economic; Ancillary; Single use reamer
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: RBHP 2021 ERIVAN; 2021-A00363-38 (Other Identifier: 2021-A00363-38)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No