Clinical trial NCT00208403: A Randomised Single Centre Study to Compare the Long-term Performance of Acryloc™ and Palacos® R Bone Cements in Primary Total Hip Replacement
Official title: Randomised, Prospective, RSA, PMS Study Comparing Acryloc™ & Palacos R in Primary Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Osteoarthritis
Post-traumatic Arthritis
Avascular Necrosis
Keywords: Hip
Cement
Lead sponsor: DePuy International
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 36
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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, 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


Eligibility criteria: 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.

Primary outcomes:
measure: Distal migration of the femoral prosthesis from the time of implantation to the 2 year follow-up assessment
timeFrame: 2 Year
Secondary outcomes:
measure: Annual posterior (AP) and medio-lateral (ML) RSA translations
timeFrame: Annually
measure: Merle D'Aubigne score
timeFrame: Annually
measure: Radiographic analysis
timeFrame: Annually
measure: Kaplan-Meier Survivorship - Revision of any component for any reason
timeFrame: Throughout Study
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: University Hospital of Trondheim
state: Sor-Trondelag
Study officials:
References: