Comparison of Wear Between Two Dual-mobility Acetabular Cups in Patients Undergoing Total Hip Arthroplasty

NCT07207005 | Not Yet Recruiting

• 1 other identifier: 2024-A02615-42
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

In 2022, data from the UK's National Joint Registry (NJR) and the American Joint Replacement Registry (AJRR) indicated that Total Hip Replacement (THR) is the most commonly performed orthopaedic joint surgery. The NJR has observed that between 10 and 20% of hip implants require revision within the first 10 years. The main reasons for these revisions include implant fractures, joint incompatibility, aseptic loosening, dislocation and wear of the polyethylene (PE) insert. To address this problem, highly cross-linked polyethylene (HXLPE) inserts have been developed. Cross-linking helps to limit wear on polyethylene prostheses in total hip arthroplasty. However, there are concerns about the loss of elasticity of HXLPE and oxidation after implantation. A new generation of inserts based on highly cross-linked polyethylene (irradiation dose ≥100 Kgy), enriched with vitamin E, has been developed. This PE, called ECIMA, was developed to maintain mechanical properties, minimise PE wear and improve long-term oxidation resistance. In the HAS evaluation report on highly cross-linked polyethylene inserts dated 24 January 2023, data from the literature show less wear of highly cross-linked polyethylene compared to conventional polyethylene. Nevertheless, the use of highly cross-linked polyethylene is not yet the gold standard. Furthermore, the data in the literature mainly concern single-mobility cups but not double-mobility cups. Finally, new imaging protocols now make it possible to assess the wear of prosthesis materials more accurately. In this context, it seems appropriate to conduct a French study comparing double-mobility cups containing highly cross-linked polyethylene or conventional polyethylene inserts.

Conditions

Hip Arthroplasty Replacement

Keywords

Hip Arthroplasty Insert

Outcome Measures

Primary Outcomes (1)

• Femoral head penetration into the acetabulum

  Femoral head penetration into the acetabulum will be mesaured in mm/year, based on a hip X-ray and PolyWare® software, Rev 8, Draftware Inc, North Webster, IN, USA

  Year 5

Study Arms (2)

Highly cross-linked PE

EXPERIMENTAL

The hip prosthesis will be a MOBILIT acetabular cup (Corin), MEIJE femoral stem (Corin), 28 mm diameter metal ball (Corin), and mobile cup (Corin) made of highly cross-linked PE doped with vitamin E (ECIMA, Corin).

Device: ECIMA CORIN

Conventional PE

ACTIVE COMPARATOR

The hip prosthesis will be a MOBILIT (Corin) acetabular prosthesis, MEIJE (Corin) femoral stem, 28 mm diameter metal ball (Corin), and mobile cup (Corin) in conventional PE.

Device: CORIN

Interventions

ECIMA CORIN DEVICE

Mobile cup (Corin) made of highly cross-linked PE doped with vitamin E (ECIMA, Corin).

Highly cross-linked PE

CORIN DEVICE

Mobile cupule (Corin) is made of conventional PE

Conventional PE

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient, male or female, aged between 55 and 80.
• Patient scheduled to undergo primary total hip arthroplasty with a dual-mobility cup prosthesis.
• Patient affiliated with or beneficiary of a social security scheme.
• Patient who speaks French and has signed an informed consent form.

You may not qualify if:

• Patients with a contraindication mentioned in the instructions for use of the medical device under investigation
• Patients with an ASA score of 4
• Protected patients: adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision
• Patients participating in another clinical study whose objectives could interfere with this study

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Hôpital Privé Jean Mermoz

Lyon, France, 69008, France

Location

Central Study Contacts

JEAN LANGLOIS, MD

CONTACT

+ 33 6 03 29 45 33; jeangast@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: October 3, 2025
• Study Start: November 15, 2025
• Primary Completion (Estimated): August 31, 2036
• Study Completion (Estimated): August 31, 2036
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)