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

DePuy Synthes logo

DePuy Synthes

Status and phase

Completed
Phase 4

Conditions

Osteoarthritis
Slipped Capital Femoral Epiphysis
Congenital Hip Dysplasia
Collagen Disorders
Avascular Necrosis
Nonunion of Femoral Fractures
Post-traumatic Arthritis
Traumatic Femoral Fractures
Rheumatoid Arthritis

Treatments

Device: SmartSet® HV bone cement
Device: SmartSet® GHV bone cement

Study type

Interventional

Funder types

Industry

Identifiers

NCT00872066
CT02/11

Details and patient eligibility

About

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

Enrollment

243 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

243 participants in 2 patient groups

1) SmartSet® HV Bone Cement
Active Comparator group
Description:
A high viscosity bone cement for use in total hip replacement (without gentamicin)
Treatment:
Device: SmartSet® HV bone cement
2) SmartSet® GHV Bone Cement
Active Comparator group
Description:
A high viscosity bone cement for use in total hip replacement (with gentamicin)
Treatment:
Device: SmartSet® GHV bone cement

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems