Post Market Clinical Follow-up of EUROSTEM Femoral Stem

• Sponsor: EUROS (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04995822
• Collaborator: (none)
• Enrollment: 131
• Locations: 10
• Anticipated Duration (Months): 138.3
• Patients Per Site: 13.1
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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

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

Detailed Description

Post market observational study. This study is multicenter, prospective, non comparative.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 131 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Post Market Clinical Follow-up of EUROSTEM Femoral Stem
• Actual Study Start Date: May 21, 2021
• Anticipated Primary Completion Date: Nov 30, 2022
• Anticipated Study Completion Date: Nov 30, 2032

Arms and Interventions

Arm	Intervention/Treatment
EUROSTEM femoral stem All patients who received EUROSTEM femoral stem whatever the version (cemented or cementless)	Device: hip arthroplasty; Hip prosthesis surgery

Outcome Measures

Primary Outcome Measures

1. Safety of EUROSTEM Femoral Stem [1 year]

   Collect the safety of the device trought complications occurence rate

Secondary Outcome Measures

1. Radiological performances of EUROSTEM Femoral Stem [1 year]

   Collect the performances of the device trought radiological evaluation

2. Clinical performances of EUROSTEM Femoral Stem [1 year]

   Collect the performances of the device trought clinical scores

3. Survival of EUROSTEM Femoral Stem [10 year]

   Assess the survival rate of the device

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patient who received EUROSTEM

• Patient informed of its participation to the study

• Patient aged over 18 to date of surgery

Exclusion Criteria:

• Patient presenting a contraindication to EUROSTEM implantation.

• Patient who refused to participate to the study

• Vulnerable subjects

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinique du Mail	Puilboreau	La Rochelle	France	17138
2	Clinique Esquirol St Hilaire	Agen		France	47000
3	CH Aix en Provence	Aix-en-Provence		France	13100
4	Polyclinique du Beaujolais	Arnas		France	69400
5	Polyclinique du Beaujolais	Arnas		France	69400
6	Clinique Montagard	Avignon		France	84000
7	Polyclinique du Parc Drevon	Dijon		France	21000
8	Clinique du Palais	Grasse		France	06130
9	Hôpital privé Drôme Ardèche - Clinique Pasteur	Guilherand Granges		France	àè(àà
10	Clinique Richelieu	Saintes		France	17100

Sponsors and Collaborators

• EUROS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: EUROS
• ClinicalTrials.gov Identifier: NCT04995822
• Other Study ID Numbers: EC-309-01
• First Posted: Aug 9, 2021
• Last Update Posted: Aug 9, 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 9, 2021