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

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01107340

Enrollment

500

Registered

2010-04-20

Start date

2010-01-31

Completion date

2028-01-31

Last updated

2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

Interventions

DEVICEAMIStem Hip System

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Assessment of implant survivorship using Kaplan Meier curve	10 years after surgery

Secondary

Measure	Time frame
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

Countries

Switzerland, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026