Post Market Clinical Follow-up of EUROSCUP Fixe Acetabular Cup

NCT05142462 | Active Not Recruiting

• 2 other identifiers: EC-310-01-012021-A01650-41
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 4

Brief Summary

EUROSCUP Fixe 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 Fixe performances and safety

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Safety of EUROSCUP Fixe

  Collect the safety of the device trought complications occurence rate

  1 year

Secondary Outcomes (3)

• Clinical performances of EUROSCUP Fixe

  1 year

• Radiological performances of EUROSCUP Fixe

  1 year

• Survival of EUROSCUP Fixe

  10 years

Study Arms (1)

EUROSCUP Fixe

120 patients who received EUROSCUP Fixe

Device: Hip arthroplasty

Interventions

Hip arthroplasty DEVICE

Hip prosthesis surgical implantation

EUROSCUP Fixe

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• 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 Fixe

You may qualify if:

• Patient who received EUROSCUP Fixe.
• 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 Fixe implantation.
• Patient who refused to participate to the study
• Vulnerable subjects

Sponsors & Collaborators

• EUROS: lead

Study Sites (4)

Clinique Esquirol Saint Hilaire

Agen, 47000, France

Location

Clinique de L'Atlantique

Puilboreau, 17138, France

Location

Centre Hospitalier SECLIN

Seclin, 59113, France

Location

Clinique St Roch

Toulon, 83000, 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: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: December 2, 2021
• Study Start: October 27, 2021
• Primary Completion: July 29, 2022
• Study Completion (Estimated): July 1, 2032
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)