Overview

This trial is active, not recruiting.

Conditions osteoarthritis, post-traumatic arthritis, avascular necrosis
Treatments smartset hv bone cement, palacos r
Phase phase 4
Sponsor DePuy International
Start date October 2002
End date January 2006
Trial size 36 participants
Trial identifier NCT00208403, CT02/08

Summary

The purpose of this study is to monitor the stability of a total hip replacement within the thigh bone when used in artificial hip joints implanted with two different bone cements, SmartSet® HV and Palacos® R, 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 Palacos® R and will be evaluated at regular intervals following hip surgery using patient, clinical, x-ray assessments and special x-rays which allow the stability of the hip implant to be determined

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
SmartSet HV
smartset hv bone cement
A high viscosity bone cement for use in total hip replacement
(Active Comparator)
Palacos R
palacos r
A high viscosity bone cement for use in total hip replacement

Primary Outcomes

Measure
Distal migration of the femoral prosthesis from the time of implantation to the 2 year follow-up assessment
time frame: 2 Year

Secondary Outcomes

Measure
Annual posterior (AP) and medio-lateral (ML) RSA translations
time frame: Annually
Merle D'Aubigne score
time frame: Annually
Radiographic analysis
time frame: Annually

Eligibility Criteria

Male or female participants from 60 years up to 75 years old.

Inclusion Criteria: i) Male or female subjects, aged 60 to 75 years (inclusive), and with a weight of less than 100kg. 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 with non-inflammatory arthritis of the hip. v) Subjects who require a primary total hip arthroplasty and are treated at the arthroplasty section of the orthopaedics department at the Investigational Centre. vi) Subjects who are considered suitable for a cemented femoral stem and cemented acetabular component. Exclusion Criteria: i) Subjects who, in the opinion of the Investigator, have an existing condition such as malignancy, severe osteoporosis, disabling musculo-skeletal problems (other than in the hips) or any other 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 undergoing corticosteroid treatment. vii) Subjects with any condition for whom the use of conventional bone cement is contra-indicated.

Additional Information

Official title Randomised, Prospective, RSA, PMS Study Comparing SmartSet HV & Palacos R in Primary Total Hip Arthroplasty
Trial information was received from ClinicalTrials.gov and was last updated in September 2011.
Information provided to ClinicalTrials.gov by DePuy International.