A Multi-centre Study to Assess the Long-term Performance of the Silent Hip™ in Primary Total Hip Replacement Surgery

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

TERMINATED

Clinical Phase

NA

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2015-07-31

Brief Summary

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The purpose of this study is to monitor the performance and of the Silent Hip™ in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments.

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Detailed Description

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Conditions

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Primary Arthritis Secondary Arthritis

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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Silent™ Hip

A short cementless, femoral component for use in total hip arthroplasty

Group Type OTHER

Silent™ Hip

Intervention Type DEVICE

A short cementless, femoral component for use in total hip arthroplasty

Interventions

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Silent™ Hip

A short cementless, femoral component for use in total hip arthroplasty

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Any subject deemed suitable to receive the Silent™ Hip in combination with the Pinnacle™ acetabular cup system, in accordance with all applicable Instructions For Use, should be considered for entry into this study.

Exclusion Criteria

* Subjects who, in the opinion of the Investigator, have an existing condition/co-morbidity or infection that would compromise their long-term participation and follow-up in this study.

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No