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

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)

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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