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

Medacta International SA2 sites in 2 countries500 target enrollmentJanuary 2010

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Osteoarthritis
Sponsor: Medacta International SA
Enrollment: 500
Locations: 2
Primary Endpoint: Assessment of implant survivorship using Kaplan Meier curve
Status: Active, not recruiting
Last Updated: last year

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

Registry

clinicaltrials.gov

Start Date

January 2010

End Date

January 2028

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

Responsible Party

Sponsor

•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)

•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.

Assessment of implant survivorship using Kaplan Meier curve

Time Frame: 10 years after surgery

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)