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

Not Applicable

Active, not recruiting

• Conditions: Congenital Hip Dysplasia; Osteoarthritis; Avascular Necrosis; Arthritis; Fracture of the Femoral Neck or Head
• Interventions: Device: AMIStem Hip System

• Registration Number: NCT01107340
• Lead Sponsor: Medacta International SA

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-04-15
• Study First Submitted QC: 2010-04-19
• Study First Posted: 2010-04-20
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-16
• Primary Completion: 2028-01
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AMIStem Hip System	AMIStem Hip System	Patients who comply with the protocol and received an AMIStem femoral component.

Primary Outcome Measures

Name	Time	Method
Assessment of implant survivorship using Kaplan Meier curve	10 years after surgery

Secondary Outcome Measures

Name	Time	Method
Assessment of the patient's physical level of activity using the Oxford Hip Score	pre-op, annually post-op up to 10 years
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
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
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

Trial Locations

Locations (2)

Uniklinik Balgrist; 🇨🇭 Zurich, Switzerland

The Elective Orthopaedic Centre (EOC); 🇬🇧 Epsom, Surrey, United Kingdom