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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

CORIN: Mobile cupule (Corin) is made of conventional PE

Study 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.

Eligibility

Primary outcome measure(s)

• Femoral head penetration into the acetabulum — Year 5
  Femoral head penetration into the acetabulum will be measured in mm/year, based on a hip X-ray and PolyWare® software, Rev 8, Draftware Inc, North Webster, IN, USA

Trial sites (1)

More GCS Ramsay Santé pour l'Enseignement et la Recherche trials in France