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Active, Not Recruiting

NCT Number: NCT04997005

The Medacta International AMIStem-P Post-Marketing Surveillance Study

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Arthrosis Arthritis Avascular Necrosis of the Femoral Head Bone Diseases Congenital Abnormalities Congenital Hip Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Developmental Dysplasia of the Hip Femur Head Necrosis Hip Dislocation, Congenital Joint Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Necrosis Osteoarthritis Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases Rheumatoid Polyarthritis Traumatic Arthritis

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique de Saint Omer, Blendecques, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

AMIStem-P

Device

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

Primary outcomes

  1. Survival rate

    Time frame: 10 years

    Kaplan Meier method

Secondary outcomes

  1. Harris Hip Score

    Time frame: 3/6 months, 1, 3, 5 and 10 years

    Harris Hip Score [min = 0 (worst clinical outcome), max = 100 (best clinical outcome)]

  2. Oxford Hip Score

    Time frame: 3/6 months, 1, 3, 5 and 10 years

    Oxford Hip Score [min = 0 (worst functional outcome), max = 48 (best functional outcome)]

  3. Radiographic performance of the implants

    Time frame: 3/6 months, 1, 3, 5 and 10 years

    Presence of radiolucencies, migration, loosening, subsidence, tilt

  4. Quality of life - Euroqol questionnaire

    Time frame: 3/6 months, 1, 3, 5 and 10 years

    EQ-5D-5L score [min = -0.59 (worst functional outcome), max = 1 (best functional outcome)]

  5. Adverse events

    Time frame: intraop, 3/6 months, 1, 3, 5 and 10 years

    Intraoperative and postoperative adverse events

Sponsors and collaborators

Lead sponsor

Medacta International SA

Industry

Registry information

Official study title

Prospective, Multicentre, Open Study Evaluating the Performance and Stability of the AMIStem-P Femoral Stem

Important dates

Study start
2019
Primary completion
2029
Study completion
2032
First posted
Aug 9, 2021
Registry last updated
May 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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