Post Market Clinical Follow-up of EUROSTEM Femoral Stem

NCT04995822 | Active Not Recruiting

• 1 other identifier: EC-309-01
• Study Type: observational
• Target: 131
• Locations: 1 country
• Sites: 9

Brief Summary

EUROSSTEM 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 EUROSTEM performances and safety

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Safety of EUROSTEM Femoral Stem

  Collect the safety of the device trought complications occurence rate

  1 year

Secondary Outcomes (3)

• Radiological performances of EUROSTEM Femoral Stem

  1 year

• Clinical performances of EUROSTEM Femoral Stem

  1 year

• Survival of EUROSTEM Femoral Stem

  10 year

Study Arms (1)

EUROSTEM femoral stem

All patients who received EUROSTEM femoral stem whatever the version (cemented or cementless)

Device: hip arthroplasty

Interventions

hip arthroplasty DEVICE

Hip prosthesis surgery

EUROSTEM femoral stem

Eligibility Criteria

• Age: 18 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 EUROSTEM

You may qualify if:

• Patient who received EUROSTEM
• Patient informed of its participation to the study
• Patient aged over 18 to date of surgery

You may not qualify if:

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

Sponsors & Collaborators

• EUROS: lead

Study Sites (9)

Clinique du Mail

Puilboreau, La Rochelle, 17138, France

Location

Clinique Esquirol St Hilaire

Agen, 47000, France

Location

CH Aix en Provence

Aix-en-Provence, 13100, France

Location

Polyclinique du Beaujolais

Arnas, 69400, France

Location

Clinique Montagard

Avignon, 84000, France

Location

Polyclinique du Parc Drevon

Dijon, 21000, France

Location

Clinique du Palais

Grasse, 06130, France

Location

Hôpital privé Drôme Ardèche - Clinique Pasteur

Guilherand-Granges, àè(àà, France

Location

Clinique Richelieu

Saintes, 17100, 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: July 30, 2021
• First Posted: August 9, 2021
• Study Start: May 21, 2021
• Primary Completion: November 6, 2022
• Study Completion (Estimated): November 6, 2032
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (9)