The Medacta International AMIStem-P Post-Marketing Surveillance Study

NCT04997005 | Active Not Recruiting

• 1 other identifier: P01.001.16
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 5

Brief Summary

This is a Post-Market Surveillance study of AMIStem-P femoral stem prosthesis

Conditions

Arthrosis; Traumatic Arthritis; Rheumatoid Polyarthritis; Congenital Hip Dysplasia; Avascular Necrosis of the Femoral Head

Outcome Measures

Primary Outcomes (1)

• Survival rate

  Kaplan Meier method

  10 years

Secondary Outcomes (5)

• Harris Hip Score

  3/6 months, 1, 3, 5 and 10 years

• Oxford Hip Score

  3/6 months, 1, 3, 5 and 10 years

• Radiographic performance of the implants

  3/6 months, 1, 3, 5 and 10 years

• Quality of life - Euroqol questionnaire

  3/6 months, 1, 3, 5 and 10 years

• Adverse events

  intraop, 3/6 months, 1, 3, 5 and 10 years

Interventions

AMIStem-P DEVICE

Performance of Total Hip Arthroplasty (THA) with AMIStem-P femoral stem implant

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 requiring Total Hip Arthroplasty and who are suitable to receive Medacta AMIStem-P femoral stem will be proposed to take part to the current post-market surveillance study during their pre-operative visit.

You may qualify if:

• Patients with a disease (primary coxarthrosis, inflammatory arthritis of the hip, necrosis of the femoral head, etc.) requiring a total hip replacement
• Patient eligible to receive an uncemented AMIStem-P femoral stem
• Patient agreeing to comply with the study requirements
• Patient willing to provide written informed consent
• Patient affiliated to a social security system
• Patients between 18 and 85 years old

You may not qualify if:

• Participation in biomedical research
• Patients younger than 18 years old
• Vulnerable adult patients according to article L1121-6 of the French Public Health Code
• Pregnant or breastfeeding women
• Patients unable to provide written informed consent

Sponsors & Collaborators

• Medacta International SA: lead

Study Sites (5)

Clinique de Saint Omer

Blendecques, 62575, France

Location

Hôpital Castres

Castres, 81108, France

Location

Nouvelle Clinique Bordeaux Tondu

Floirac, 33270, France

Location

Clinique d'Orange

Orange, 84100, France

Location

Hôpital Jacques-Puel

Rodez, 12000, France

Location

MeSH Terms

Conditions

Osteoarthritis; Hip Dislocation, Congenital; Femur Head Necrosis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Developmental Dysplasia of the Hip; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Osteonecrosis; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexandru Nebunescu-Schirliu, MD

  Hôpital Jacques-Puel

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 9, 2021
• Study Start: April 26, 2019
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): December 31, 2032
• Last Updated: May 8, 2025

Record last verified: 2025-05

Locations

FR (5)