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Clinical Trials in the UK / NCT01107340
Active, not recruiting Not applicable

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

NCT01107340 · tracked via the Priya Life Science UK tracker
Sponsor
Medacta International SA
Phase
Not applicable
Started
2010-01
Last updated
2024-12-16

Condition(s) studied

OsteoarthritisArthritisAvascular NecrosisFracture of the Femoral Neck or HeadCongenital Hip Dysplasia

Investigational drug(s) / intervention(s)

AMIStem Hip System

Study summary

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

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Assessment of implant survivorship using Kaplan Meier curve — 10 years after surgery

Trial sites (2)

FacilityCityRegionStatus
Uniklinik Balgrist Zurich Switzerland
The Elective Orthopaedic Centre (EOC) Epsom Surrey

More Medacta International SA trials in the UK

The Medacta International GMK Sphere Post-Marketing Surveillance Study Active, not recruiting
The Medacta International SMS Post-Marketing Surveillance Study Recruiting

Other trials for the same condition

The Medacta International GMK Sphere Post-Marketing Surveillance Study Active, not recruiting
A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee Active, not recruiting
The Medacta International SMS Post-Marketing Surveillance Study Recruiting
Post Market Clinical Follow-Up Study for EVOLUTION® NitrX™ Keeled Tibia and EVOLUTION® NitrX™ CS/CR Femur With Cruciate Sacrificing Insert Enrolling by invitation
Efficacy and Safety of Eloralintide (LY3841136) in Participants With Osteoarthritis Knee Pain and Obesity or Overweight Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01107340 on ClinicalTrials.gov ↗ ← All trials in the UK