Comparison of the Use of Conventional Ancillary Reaming and Single-use Ancillary Reaming Material in Total Hip Replacement (LUUC)
Primary Purpose
Total Hip Replacement, Coxarthrosis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
total hip replacement with single use ancillary
total hip replacement with conventional ancillary
Sponsored by
About this trial
This is an interventional treatment trial for Total Hip Replacement focused on measuring Prospective, Randomized study, Medico-economic, Sterilization, Single use reamer, Ancillary
Eligibility Criteria
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
Sites / Locations
- CHU clermont-ferrand
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Single use reamers
conventional ancillary
Arm Description
Total hip replacement with the use of disposable reamers
Total hip replacement with the use of conventional reamers
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Surgical time
Calculated from the beginning of the skin incision to closure and recorded on the anesthesia sheet
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.
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.
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
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).
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.
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).
Operator satisfaction
Operator satisfaction score (numerical scale from 0 (not satisfied) to 10 (very satisfied)) of the material during the surgical procedure
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
Complications
Analysis of possible intraoperative and postoperative complications and their costs: loosening, infection, dislocation, wear and implant fracture
Full Information
NCT ID
NCT04903860
First Posted
May 12, 2021
Last Updated
July 27, 2022
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Groupe Lépine
1. Study Identification
Unique Protocol Identification Number
NCT04903860
Brief Title
Comparison of the Use of Conventional Ancillary Reaming and Single-use Ancillary Reaming Material in Total Hip Replacement
Acronym
LUUC
Official Title
Comparison of the Use of Conventional Ancillary Reaming and Single-use Ancillary Reaming Material in Total Hip Replacement
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
July 12, 2021 (Actual)
Primary Completion Date
July 27, 2022 (Actual)
Study Completion Date
July 27, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Groupe Lépine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Hip Replacement, Coxarthrosis
Keywords
Prospective, Randomized study, Medico-economic, Sterilization, Single use reamer, Ancillary
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single use reamers
Arm Type
Active Comparator
Arm Description
Total hip replacement with the use of disposable reamers
Arm Title
conventional ancillary
Arm Type
Active Comparator
Arm Description
Total hip replacement with the use of conventional reamers
Intervention Type
Device
Intervention Name(s)
total hip replacement with single use ancillary
Intervention Description
Comparison of the use of conventional ancillary reaming and single-use ancillary reaming material in total hip replacement
Intervention Type
Device
Intervention Name(s)
total hip replacement with conventional ancillary
Intervention Description
Comparison of the use of conventional ancillary reaming and single-use ancillary reaming material in total hip replacement
Primary Outcome Measure Information:
Title
Overall cost of surgery
Description
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 Outcome Measure Information:
Title
Surgical time
Description
Calculated from the beginning of the skin incision to closure and recorded on the anesthesia sheet
Time Frame
intraoperative
Title
Modified Merle d'Aubigné and Postel Method score
Description
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
Title
Harris Hip Score
Description
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
Title
Charnley classification and Devane score
Description
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
Time Frame
Pré-opérative examination / At 3 months
Title
WOMAC score
Description
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).
Time Frame
Pré-opérative examination / At 3 months
Title
HOOS score
Description
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.
Time Frame
Pré-opérative examination / At 3 months
Title
Pain evaluation
Description
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).
Time Frame
Pré-opérative examination / At 3 months
Title
Operator satisfaction
Description
Operator satisfaction score (numerical scale from 0 (not satisfied) to 10 (very satisfied)) of the material during the surgical procedure
Time Frame
through surgical intervention an average of 1 day
Title
Radiological analysis
Description
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
Time Frame
At 3 months
Title
Complications
Description
Analysis of possible intraoperative and postoperative complications and their costs: loosening, infection, dislocation, wear and implant fracture
Time Frame
At 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger ERIVAN
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU clermont-ferrand
City
Clermont-Ferrand
Country
France
12. IPD Sharing Statement
Learn more about this trial
Comparison of the Use of Conventional Ancillary Reaming and Single-use Ancillary Reaming Material in Total Hip Replacement
We'll reach out to this number within 24 hrs