Back to resultsInterest of a Highly Cross-linked Polyethylene Acetabular Component Doped With Vitamin E in Total Hip Arthroplasty of the Young and Active Subject (ICARE)
Primary Purpose
Hip Arthropathy
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Prosthesis with a second-generation ceramic-on-highly cross-linked polyethylene (CoPXE) couple.
Prosthesis with ceramic-on-ceramic (CoC) torque.
Sponsored by
About this trial
This is an interventional prevention trial for Hip Arthropathy
Eligibility Criteria
Inclusion Criteria:
- Patient aged 18 to 65 years,
- Who have signed their consent to participate in the study,
- For whom an indication for total hip arthroplasty has been given
Exclusion Criteria:
- History of hip surgery
- Indication for a dual mobility prosthesis (obese patient, dynamic spino-pelvic anomaly)
- Hip dysplasia
- Inflammatory rheumatic disease or any other progressive concomitant condition that may impact the patient's vital or functional prognosis
- Sequelae of neurological disease or stroke
- Pregnant or breastfeeding women
- Mental deficiency or any other reason that may hinder the understanding or the strict application of the protocol
- Patient likely not to return for follow-up visits
- Patient already included in another therapeutic study protocol
- Patient under court protection, guardianship or curatorship.
Sites / Locations
- Hôpital Privé Jean Mermoz
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group 1
Group 2
Arm Description
Prosthesis with a second-generation ceramic-on-highly cross-linked polyethylene (CoPXE) couple.
Prosthesis with ceramic-on-ceramic (CoC) torque.
Outcomes
Primary Outcome Measures
five-year wear thickness of the two friction pairs
The primary endpoint is the five-year wear thickness of the two friction pairs (CoPXE versus CoC) after total hip arthroplasty. Wear thickness is the measurement of the penetration of the femoral head into the acetabular component. This measurement will be performed on frontal pelvic radiographs centred on the pubic symphysis using the semi-automatic computer-assisted technique described by Martell
Secondary Outcome Measures
Full Information
NCT ID
NCT05175300
First Posted
December 14, 2021
Last Updated
December 14, 2021
Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
1. Study Identification
Unique Protocol Identification Number
NCT05175300
Brief Title
Interest of a Highly Cross-linked Polyethylene Acetabular Component Doped With Vitamin E in Total Hip Arthroplasty of the Young and Active Subject
Acronym
ICARE
Official Title
Interest of a Highly Cross-linked Polyethylene Acetabular Component Doped With Vitamin E in Total Hip Arthroplasty of the Young and Active Subject
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 1, 2022 (Anticipated)
Primary Completion Date
February 1, 2029 (Anticipated)
Study Completion Date
February 1, 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
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
Interest of a highly cross-linked polyethylene acetabular component doped with vitamin E in total hip arthroplasty of the young and active subject.
Detailed Description
A single-centre, prospective, randomised, single-blind, comparative study of two parallel groups of patients undergoing total hip arthroplasty:
Group 1: Prosthesis with a second-generation ceramic-on-highly cross-linked polyethylene (CoPXE) couple.
Group 2: Prosthesis with ceramic-on-ceramic (CoC) torque.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Arthropathy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A single-centre, prospective, randomised, single-blind, comparative, category 2 study of two parallel groups of patients undergoing total hip arthroplasty:
Group 1: Prosthesis with a second-generation ceramic-on-highly cross-linked polyethylene (CoPXE) couple.
Group 2: Prosthesis with ceramic-on-ceramic (CoC) torque.
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Prosthesis with a second-generation ceramic-on-highly cross-linked polyethylene (CoPXE) couple.
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Prosthesis with ceramic-on-ceramic (CoC) torque.
Intervention Type
Device
Intervention Name(s)
Prosthesis with a second-generation ceramic-on-highly cross-linked polyethylene (CoPXE) couple.
Intervention Description
Prosthesis with a second-generation ceramic-on-highly cross-linked polyethylene (CoPXE) couple.
Intervention Type
Device
Intervention Name(s)
Prosthesis with ceramic-on-ceramic (CoC) torque.
Intervention Description
Prosthesis with ceramic-on-ceramic (CoC) torque.
Primary Outcome Measure Information:
Title
five-year wear thickness of the two friction pairs
Description
The primary endpoint is the five-year wear thickness of the two friction pairs (CoPXE versus CoC) after total hip arthroplasty. Wear thickness is the measurement of the penetration of the femoral head into the acetabular component. This measurement will be performed on frontal pelvic radiographs centred on the pubic symphysis using the semi-automatic computer-assisted technique described by Martell
Time Frame
Year 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient aged 18 to 65 years,
Who have signed their consent to participate in the study,
For whom an indication for total hip arthroplasty has been given
Exclusion Criteria:
History of hip surgery
Indication for a dual mobility prosthesis (obese patient, dynamic spino-pelvic anomaly)
Hip dysplasia
Inflammatory rheumatic disease or any other progressive concomitant condition that may impact the patient's vital or functional prognosis
Sequelae of neurological disease or stroke
Pregnant or breastfeeding women
Mental deficiency or any other reason that may hinder the understanding or the strict application of the protocol
Patient likely not to return for follow-up visits
Patient already included in another therapeutic study protocol
Patient under court protection, guardianship or curatorship.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean LANGLOIS, MD
Phone
0603294533
Ext
33
Email
jeangast@gmail.com
Facility Information:
Facility Name
Hôpital Privé Jean Mermoz
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean LANGLOIS, MD
Phone
0603294533
Ext
33
Email
jeangast@gmail.com
First Name & Middle Initial & Last Name & Degree
Jean LANGLOIS, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Interest of a Highly Cross-linked Polyethylene Acetabular Component Doped With Vitamin E in Total Hip Arthroplasty of the Young and Active Subject
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