AMIStem Primary Hip System Prospective Post-marketing Multi-centre Surveillance Study (NCT01107340) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
AMIStem Primary Hip System Prospective Post-marketing Multi-centre Surveillance Study
Switzerland, United Kingdom500 participantsStarted 2010-01
Plain-language summary
This is a multicentre post-marketing prospective study to evaluate performance and clinical outcomes of AMIIStem primary hip system.
Who can participate
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Assessment of implant survivorship using Kaplan Meier curve