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

• Sponsor: EUROS (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04993638
• Collaborator: (none)
• Enrollment: 147
• Locations: 4
• Anticipated Duration (Months): 156
• Patients Per Site: 36.8
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Hip Arthropathy; Hip Osteoarthritis; Hip Arthritis; Hip Fractures; Hip Necrosis; Hip Dysplasia	Device: hip arthroplasty

Detailed Description

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

Study Design

• Study Type: Observational
• Anticipated Enrollment: 147 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Post Market Clinical Follow-up of Dual-mobility Acetabular Cup EUROSCUP MOBILE
• Actual Study Start Date: Jun 1, 2021
• Anticipated Primary Completion Date: Jun 1, 2024
• Anticipated Study Completion Date: Jun 1, 2034

Arms and Interventions

Arm	Intervention/Treatment
EUROSCUP MOBILE cementless 107 who received cementless version of EUROSCUP MOBILE	Device: hip arthroplasty; Hip prosthesis surgery
EUROSCUP MOBILE cemented 40 who received cemented version of EUROSCUP MOBILE	Device: hip arthroplasty; Hip prosthesis surgery

Outcome Measures

Primary Outcome Measures

1. Safety of EUROSCUP MOBILE [1 year]

   Collect the safety of the device trought complications occurence rate

Secondary Outcome Measures

1. Radiological performances of EUROSCUP MOBILE [1 year]

   Collect the performances of the device trought radiological evaluation

2. Clinical performances of EUROSCUP MOBILE [1 year]

   Collect the performances of the device trought clinical scores

3. Survival of EUROSCUP MOBILE [10 year]

   Assess the survival rate of the device

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

• Patient presenting a contraindication to EUROSCUP MOBILE implantation.

• Patient who refused to participate to the study

• Vulnerable subjects

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinique Montagard	Avignon		France	84000
2	Clinique montagard	Avignon		France	84000
3	CHU Gabriel Montpied	Clermont-Ferrand		France	63000
4	Hôpital Saint Joseph-Saint Luc	Lyon		France	69007

Sponsors and Collaborators

• EUROS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: EUROS
• ClinicalTrials.gov Identifier: NCT04993638
• Other Study ID Numbers: EC-310-02-01-A
• First Posted: Aug 6, 2021
• Last Update Posted: Aug 6, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Osteoarthritis, Hip; Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital; Necrosis; Hip Fractures

Study Results

No Results Posted as of Aug 6, 2021