EBRA Study AMISTEM-C FR

NCT05848024 | Active Not Recruiting

• 1 other identifier: P01.001.10
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Primary objective: Evaluate femoral stem migration Secondary objective: Evaluate the performance of AMIStem H Proximal Coating at 10 years after surgery; assessment of functional recovery; radiological evaluation; reporting of complications Scores collected: HHS, OHS, PMA, UCLA

Conditions

Total Hip Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Assess the femoral stem migration

  The primary endpoint is the measurement of femoral component migration by EBRA-FCA software (The Ein Bild Roentgen Analyse-femoral component analysis, Innsbruck, Austria) with an accuracy of ± 1.5 mm (95% percentile), a specificity of 100% and a sensitivity of 78% for the detection of a migration of more than 1.0 mm, referring to the RSA method. The EBRA-FCA method is based on the detection of 19 points on the bony femur and the femoral component, as well as two lines to determine the axis of the implant on successive radiographs of the front pelvis. The correction of the radiological enlargement is performed based on the known diameter of the prosthetic femoral component. Lengths are measured from anatomical reference points to ensure comparability of the radiographs. The change in the distance between the top of the greater trochanter and the shoulder of the prosthesis is used to measure the migration of the femoral component.

  2 years

Secondary Outcomes (6)

• Assess the AMIStem C performance at 10 years

  10 years

• Assess the functionality of the operated hip

  pre-op, 7 days, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years and 10 years

• Assess the Quality of Life of patients

  pre-op, 7 days, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years and 10 years

• Assess the security of AMIStem C and collect complications

  pre-op, 7 days, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years and 10 years

• Assess the postoperative stability and fixation of AMIStem C

  pre-op, 7 days, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years and 10 years

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a disease (primary coxarthrosis, inflammatory arthritis of the hip, necrosis of the femoral head, etc.) requiring a total hip replacement and who will receive an AMIStem® C cemented femoral stem. Patients will be able to participate in other non-interventional research during the study.

You may qualify if:

• Patient with a disease (primary coxarthrosis, inflammatory arthritis of the hip, necrosis of the femoral head...) requiring the placement of a total hip prosthesis.
• Patient who will receive an AMIStem® C cemented femoral stem.
• Patient willing to comply with the study requirements
• Patient who has signed the information letter agreeing to the processing of their data in the clinical evaluation
• Patient affiliated to a social security system
• Patients aged 18 to 85 years
• Participation in biomedical research
• Minor patients
• Protected adult patients
• Vulnerable persons according to article L1121-6 of the Public Health Code
• Pregnant or breastfeeding women
• Patients unable to formulate their non-opposition
• Patient refusing collection of personal data

Sponsors & Collaborators

• Medacta International SA: lead

Study Sites (1)

Hôpital privé Arras Les Bonnettes

Arras, France

Location

Study Officials

• Donatien Bocquet

  Hôpital privé Arras Les Bonnettes 2 rue du docteur Forgeois 62012 Arras

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 21, 2023
• First Posted: May 8, 2023
• Study Start: February 8, 2017
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2029
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)