A Randomised Single Centre Study to Compare the Long-term Performance of Acryloc™ and Palacos® R Bone Cements in Primary Total Hip Replacement
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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, Acryloc™ 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 Acryloc™ 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
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
36 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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