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

Medacta

Status: Active, not recruiting

Conditions: Osteoarthritis; Fracture of the Femoral Neck or Head; Arthritis; Congenital Hip Dysplasia; Avascular Necrosis

Treatments: Device: AMIStem Hip System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01107340

P01.004.11

Details and patient eligibility

About

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

Enrollment: 500 estimated patients

Sex: All

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 1 patient group

AMIStem Hip System

Other group

Description:

Patients who comply with the protocol and received an AMIStem femoral component.

Treatment:

Device: AMIStem Hip System