AMIStem Primary Hip System Prospective Post-marketing Multi-centre Surveillance Study

Osteoarthritis Clinical Trial

Official title:

AMIStem Primary Hip System Prospective Post-marketing Multi-centre Surveillance Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01107340
• Other study ID #: P01.004.11
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2010
• Est. completion date: January 2028

Study information

• Verified date: December 2023
• Source: Medacta International SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multicentre post-marketing prospective study to evaluate performance and clinical outcomes of AMIIStem primary hip system.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: January 2028
• Est. primary completion date: January 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patient is a good candidate for a primary hip arthroplasty using AMIStem Hip System

• Patient is willing and able to give informed consent to participate in the follow-up program

• Patient is suitable for surgery and able to participate in the follow-up program.

• Those presenting with disease that meets the indication for use for Medacta implants defined in the study (on-label use)

Exclusion Criteria:

• Acute systemic or chronic infection

• Skeletal immaturity

• Severe muscular, neurological, vascular deficiency or other pathologies of the affected limb that may compromise the stability of the implant.

• Bone condition that may compromise the stability of the implant.

• Patient who are unwilling or unable to give consent, or to comply with the protocol and the follow-up program.

Related Conditions & MeSH terms

• Arthritis
• Avascular Necrosis
• Congenital Hip Dysplasia
• Developmental Dysplasia of the Hip
• Fracture of the Femoral Neck or Head
• Hip Dislocation
• Hip Dislocation, Congenital
• Necrosis
• Osteoarthritis

Intervention

Device:
• AMIStem Hip System

Locations

Country	Name	City	State
Switzerland	Uniklinik Balgrist	Zurich
United Kingdom	The Elective Orthopaedic Centre (EOC)	Epsom	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Medacta International SA

Countries where clinical trial is conducted

Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of implant survivorship using Kaplan Meier curve		10 years after surgery
Secondary	Assessment of the patient's physical level of activity using the Oxford Hip Score		pre-op, annually post-op up to 10 years
Secondary	Assessment of the improvement in quality of life and joint movement using the EuroQol-5D score		pre-op, annually post-op up to 10 years
Secondary	Assessment of implant survivorship as a measure of safety using Kaplan Meier curve		6 months, 3 years, 5 years, 7.5 years, 10 years after surgery
Secondary	Assessment of the clinical outcome following total hip replacement using the Harris Hip Score		pre-op, 6 months, 3 years, 5 years, 7.5 years, 10 years after surgery