The Medacta International AMIStem-P Post-Marketing Surveillance Study

Traumatic Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04997005
• Other study ID #: P01.001.16
• Status: Active, not recruiting
• Start date: April 26, 2019
• Est. completion date: December 31, 2032

Study information

• Verified date: April 2024
• Source: Medacta International SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 550
• Est. completion date: December 31, 2032
• Est. primary completion date: April 30, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthrosis
• Avascular Necrosis of the Femoral Head
• Congenital Hip Dysplasia
• Developmental Dysplasia of the Hip
• Hip Dislocation
• Hip Dislocation, Congenital
• Necrosis
• Osteoarthritis
• Rheumatoid Polyarthritis
• Traumatic Arthritis

Intervention

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

Locations

Country	Name	City	State
France	Clinique de Saint Omer	Blendecques
France	Hôpital Castres	Castres
France	Nouvelle Clinique Bordeaux Tondu	Floirac
France	Clinique d'Orange	Orange
France	Hôpital Jacques-Puel	Rodez

Sponsors (1)

Lead Sponsor	Collaborator
Medacta International SA

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rate	Kaplan Meier method	10 years
Secondary	Harris Hip Score	Harris Hip Score [min = 0 (worst clinical outcome), max = 100 (best clinical outcome)]	3/6 months, 1, 3, 5 and 10 years
Secondary	Oxford Hip Score	Oxford Hip Score [min = 0 (worst functional outcome), max = 48 (best functional outcome)]	3/6 months, 1, 3, 5 and 10 years
Secondary	Radiographic performance of the implants	Presence of radiolucencies, migration, loosening, subsidence, tilt	3/6 months, 1, 3, 5 and 10 years
Secondary	Quality of life - Euroqol questionnaire	EQ-5D-5L score [min = -0.59 (worst functional outcome), max = 1 (best functional outcome)]	3/6 months, 1, 3, 5 and 10 years
Secondary	Adverse events	Intraoperative and postoperative adverse events	intraop, 3/6 months, 1, 3, 5 and 10 years