Working… Menu

A Randomised Single Centre Study to Compare the Long-term Performance of Acryloc™ and Palacos® R Bone Cements in Primary Total Hip Replacement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00208403
Recruitment Status : Terminated
First Posted : September 21, 2005
Last Update Posted : March 28, 2017
Information provided by (Responsible Party):
DePuy International

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

Condition or disease Intervention/treatment Phase
Osteoarthritis Post-traumatic Arthritis Avascular Necrosis Device: Acryloc™ GHV Device: Palacos R Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomised, Prospective, RSA, PMS Study Comparing Acryloc™ & Palacos R in Primary Total Hip Arthroplasty
Study Start Date : October 2002
Actual Primary Completion Date : October 2005
Actual Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement

Arm Intervention/treatment
Active Comparator: 1
Acryloc™ GHV
Device: Acryloc™ GHV
A high viscosity bone cement for use in total hip replacement

Active Comparator: 2
Palacos R
Device: Palacos R
A high viscosity bone cement for use in total hip replacement

Primary Outcome Measures :
  1. Distal migration of the femoral prosthesis from the time of implantation to the 2 year follow-up assessment [ Time Frame: 2 Year ]

Secondary Outcome Measures :
  1. Annual posterior (AP) and medio-lateral (ML) RSA translations [ Time Frame: Annually ]
  2. Merle D'Aubigne score [ Time Frame: Annually ]
  3. Radiographic analysis [ Time Frame: Annually ]
  4. Kaplan-Meier Survivorship - Revision of any component for any reason [ Time Frame: Throughout Study ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   60 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00208403

Layout table for location information
University Hospital of Trondheim
Trondheim, Sor-Trondelag, Norway
Sponsors and Collaborators
DePuy International

Layout table for additonal information
Responsible Party: DePuy International Identifier: NCT00208403     History of Changes
Other Study ID Numbers: CT02/08
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: March 2017
Keywords provided by DePuy International:
Additional relevant MeSH terms:
Layout table for MeSH terms
Pathologic Processes
Polymethyl Methacrylate
Vasodilator Agents
Antimutagenic Agents
Protective Agents
Physiological Effects of Drugs