A Study to Assess the Long-term Performance of SmartSet® HV and SmartSet® GHV Bone Cements in Primary Total Hip Replacement

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

243 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2016-07-31

Brief Summary

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The purpose of this study is to monitor the performance of artificial hip joints implanted with two different bone cements, SmartSet® HV and SmartSet® GHV, in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be randomly allocated to SmartSet® HV or SmartSet® GHV and 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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Rheumatoid Arthritis Osteoarthritis Post-traumatic Arthritis Collagen Disorders Avascular Necrosis Traumatic Femoral Fractures Nonunion of Femoral Fractures Congenital Hip Dysplasia Slipped Capital Femoral Epiphysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1) SmartSet® HV Bone Cement

A high viscosity bone cement for use in total hip replacement (without gentamicin)

Group Type ACTIVE_COMPARATOR

SmartSet® HV bone cement

Intervention Type DEVICE

A high viscosity bone cement for use in total hip replacement (without gentamicin)

2) SmartSet® GHV Bone Cement

A high viscosity bone cement for use in total hip replacement (with gentamicin)

Group Type ACTIVE_COMPARATOR

SmartSet® GHV bone cement

Intervention Type DEVICE

A high viscosity bone cement for use in total hip replacement (with gentamicin)

Interventions

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SmartSet® HV bone cement

A high viscosity bone cement for use in total hip replacement (without gentamicin)

Intervention Type DEVICE

SmartSet® GHV bone cement

A high viscosity bone cement for use in total hip replacement (with gentamicin)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

i) Male or female subjects, aged between 18 and 75 years (inclusive).

ii) Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.

iii) Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.

iv) Subjects requiring primary total hip arthroplasty and are considered suitable for a cemented femoral component.

Exclusion Criteria

i) Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.

ii) Women who are pregnant.

iii) Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.

iv) Subjects who have participated in a clinical study with an investigational product in the last 6 month(s).

v) Subjects who are currently involved in any injury litigation claims.

vi) Subjects with contraindications normally applicable to the use of conventional bone cement, in accordance with the manufacturer's Instructions For Use.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No