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Active, not recruitingNCT04993638Updated Aug 28, 2024

Post Market Clinical Follow-up of Dual-mobility Acetabular Cup EUROSCUP MOBILE

An observational study in Hip Arthropathy, Hip Osteoarthritis and Hip Arthritis, sponsored by EUROS. Active, not recruiting at 3 sites in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-08-28.

Sponsored by EUROS · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
147
Ages
18 Years to 80 Years
Sex
All
01

Study summary

EUROSCUP MOBILE is intended for use in primary and revision total hip replacement surgery.

Hip replacement is intended to provide increased patient mobility and reduce pain by replacing the damages hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

As part of post market vigilance, EUROS will collect data on EUROSCUP MOBILE performances and safety

Read the detailed description

Post market observational study. This study is retropective and prospective, non comparative.

02

Conditions studied

  • Hip Arthropathy
  • Hip Osteoarthritis
  • Hip Arthritis
  • Hip Fractures
  • Hip Necrosis
  • Hip Dysplasia
03

In context

Osteoarthritis, Hip

628 studies on the registry are indexed under Osteoarthritis, Hip; 121 are open to participants now.

This study's enrollment of 147 is close to the median of 141 across 154 observational studies indexed under Osteoarthritis, Hip.

Browse Osteoarthritis, Hip studies →

Lead sponsor

EUROS is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patient who fulfill the criteria of eligilibilty according to the instructions for use of EUROSCUP MOBILE

Inclusion criteria

  • Patient who received EUROSCUP MOBILE.
  • Patient informed of its participation to the study
  • Patient aged between 18 and 80 years old (\<80).

Exclusion criteria

Exclusion Criteria:

  • Patient presenting a contraindication to EUROSCUP MOBILE implantation.
  • Patient who refused to participate to the study
  • Vulnerable subjects
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
147 participants (actual)
Patient registry
No

Groups and cohorts

  • EUROSCUP MOBILE cementless

    107 who received cementless version of EUROSCUP MOBILE

    Device: hip arthroplasty

  • EUROSCUP MOBILE cemented

    40 who received cemented version of EUROSCUP MOBILE

    Device: hip arthroplasty

Interventions

  • Devicehip arthroplasty

    Hip prosthesis surgery

06

What researchers measure

Primary outcomes

  1. Safety of EUROSCUP MOBILE

    Collect the safety of the device trought complications occurence rate

    Time frame: 1 year

Secondary outcomes

  1. Radiological performances of EUROSCUP MOBILE

    Collect the performances of the device trought radiological evaluation

    Time frame: 1 year

  2. Clinical performances of EUROSCUP MOBILE

    Collect the performances of the device trought clinical scores

    Time frame: 1 year

  3. Survival of EUROSCUP MOBILE

    Assess the survival rate of the device

    Time frame: 10 year

07

Study locations

3 sites
  • Clinique Montagard
    Avignon, 84000, France
  • CHU Gabriel Montpied
    Clermont-Ferrand, 63000, France
  • Hôpital Saint Joseph-Saint Luc
    Lyon, 69007, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04993638
Lead sponsor
EUROS
Responsible party
Sponsor
First posted
Aug 6, 2021
Start date
Jun 1, 2021
Primary completion
Jun 1, 2034 (estimated)
Completion
Jun 2034 (estimated)
Last update
Aug 28, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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