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

NCT04993638 | Active Not Recruiting

• 1 other identifier: EC-310-02-01-A
• Study Type: observational
• Target: 147
• Locations: 1 country
• Sites: 3

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

Conditions

Hip Arthropathy; Hip Osteoarthritis; Hip Arthritis; Hip Fractures; Hip Necrosis; Hip Dysplasia

Outcome Measures

Primary Outcomes (1)

• Safety of EUROSCUP MOBILE

  Collect the safety of the device trought complications occurence rate

  1 year

Secondary Outcomes (3)

• Radiological performances of EUROSCUP MOBILE

  1 year

• Clinical performances of EUROSCUP MOBILE

  1 year

• Survival of EUROSCUP MOBILE

  10 year

Study Arms (2)

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

hip arthroplasty DEVICE

Hip prosthesis surgery

EUROSCUP MOBILE cemented; EUROSCUP MOBILE cementless

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• EUROS: lead

Study Sites (3)

Clinique Montagard

Avignon, 84000, France

Location

CHU Gabriel Montpied

Clermont-Ferrand, 63000, France

Location

Hôpital Saint Joseph-Saint Luc

Lyon, 69007, France

Location

MeSH Terms

Conditions

Osteoarthritis, Hip; Hip Fractures; Hip Dislocation

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Joint Dislocations

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: August 6, 2021
• Study Start: June 1, 2021
• Primary Completion (Estimated): June 1, 2034
• Study Completion (Estimated): June 1, 2034
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)