Interest of a Highly Cross-linked Polyethylene Acetabular Component Doped With Vitamin E in Total Hip Arthroplasty of the Young and Active Subject

Hip Arthropathy Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05175300
• Other study ID #: 2021-A02040-41
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: February 1, 2029

Study information

• Verified date: December 2021
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: Jean LANGLOIS, MD
• Phone: 0603294533
• Email: jeangast[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Interest of a highly cross-linked polyethylene acetabular component doped with vitamin E in total hip arthroplasty of the young and active subject.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: February 1, 2029
• Est. primary completion date: February 1, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hip Arthropathy
• Joint Diseases

Intervention

Device:
• Prosthesis with a second-generation ceramic-on-highly cross-linked polyethylene (CoPXE) couple.
Prosthesis with a second-generation ceramic-on-highly cross-linked polyethylene (CoPXE) couple.
• Prosthesis with ceramic-on-ceramic (CoC) torque.
Prosthesis with ceramic-on-ceramic (CoC) torque.

Locations

Country	Name	City	State
France	Hôpital Privé Jean Mermoz	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Year 5