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NCT Number: NCT06917365

Clinical Performance of XPEO-E Liner in SERF Dual-mobility Cups

XPEO-E liner is CE marked under MDD 93/42/CEE by equivalency with CI E liner. No pertaining data on XPEO-E liner is yet available. However, clinical evaluation concludes on a reaching of performance and safety and compliance with essential requirements. This study intends to collect data on XPEO-E in order to allow a transit to MDR 2017/745 (EU).

XPEO-E liner is intended to be used with NOVAE cups and SERF femoral heads and Stems. XPEO-E liner will be used according to their CE marking. These devices are intended for hip replacements with the aim of improving quality of life and reducing pain by replacing a damaged joint.

The follow-up visits are established according to the current practice. Additional procedure will only consist on questionnaires that will be filled by the patient and/or the surgeons.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Dijon, Dijon, France

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Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female adults.
  • Patient that needs to be implanted with a SERF total hip prosthesis.
  • Patient responding to IFU requirement.
  • Patient affiliated to French social security.
  • Patient who has provided a dated and signed informed consent form.

Exclusion criteria

  • Patient protected by a French legal measure (under legal protection, guardianship or curatorship).
  • Patient unable of expressing consent, according to the investigator.
  • Patient deprived of liberty or hospitalized against his consent.
  • Pregnant or breastfeeding patient.
  • Patient presenting a contraindication to the implantation of medical devices according to the instructions for use.
  • Patient with a contraindication to radiographic follow-up.
  • Patient not being, a priori, capable of respecting the schedule of follow-up visits, according to the investigator.
  • Patient unable to complete a self-questionnaire, according to the investigator.

Treatment and study plan

Primary outcomes

  1. Functional improvement

    Time frame: Per operative period to 5 years

    To assess the evolution of patient's functional capacity post-implantation using Harris Hips score (measured from 0 to 100 points, the higher the score the better the outcome)

Secondary outcomes

  1. Survival rate

    Time frame: Per operative period to 5 years

    Calculated using the Kaplan-Meier method

  2. Functional improvement

    Time frame: Per operative period to 5 years

    To assess the evolution of patient's functional capacity post-implantation using HOOS score (40-item questionnaire mesured from 0 to 100, with 100 indicating no symptoms and 0 indicating extreme symptoms )

  3. Functional improvement

    Time frame: Per operative period to 5 years

    To assess the evolution of patient's activity post-implantation using Charnley score

  4. Pain release

    Time frame: Pre operative period to 5 years

    To assess patient's pain (Visual Analogic Scale measured on a scale of 0 to 10 to reflect the intensity of the pain)

  5. Patient's quality of life

    Time frame: Pre operative period to 5 years

    To assess patient's quality of life post-implantation (Forgotten Joint Score mesured from 0 to 100, the higher the score, the less the patient is aware of their affected joint when performing daily activities)

  6. Patient's satisfaction

    Time frame: Post operative period to 5 years

    To assess patients' satisfaction with the operation (4-points question)

  7. Adverse events

    Time frame: Per operative period to 5 years

    To assess the long-term safety of investigational medical devices as well as post-operative safety of the surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical department

CONTACT

[email protected]

+33472056010

Sponsors and collaborators

Lead sponsor

Societe dEtude, de Recherche et de Fabrication

Industry

Registry information

Acronym: 2024-01-XPEO-E

Important dates

Study start
2025
Primary completion
2032
Study completion
2032
First posted
Apr 8, 2025
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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