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

NCT ID: NCT01107340

Last Updated: 2024-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2028-01-31

Brief Summary

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

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AMIStem Hip System

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

Group Type OTHER

AMIStem Hip System

Intervention Type DEVICE

Interventions

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AMIStem Hip System

Intervention Type DEVICE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medacta International SA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard E Field, PhD FRCS

Role: PRINCIPAL_INVESTIGATOR

British Orthopaedic Association

Locations

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Uniklinik Balgrist

Zurich, , Switzerland

Site Status

The Elective Orthopaedic Centre (EOC)

Epsom, Surrey, United Kingdom

Site Status

Countries

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Switzerland United Kingdom

Other Identifiers

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P01.004.11

Identifier Type: -

Identifier Source: org_study_id