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

Randomised, Prospective, RSA, PMS Study Comparing Acryloc™ & Palacos R in Primary Total Hip Arthroplasty

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

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis; Avascular Necrosis; Post-traumatic Arthritis
• Intervention / Treatment: Device: Acryloc™ GHV; Device: Palacos R

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 4

Contacts and Locations

Study Locations

• Norway
  • Sor-Trondelag
    • Trondheim, Sor-Trondelag, Norway
      • University Hospital of Trondheim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Distal migration of the femoral prosthesis from the time of implantation to the 2 year follow-up assessment	2 Year

Secondary Outcome Measures

Outcome Measure	Time Frame
Annual posterior (AP) and medio-lateral (ML) RSA translations	Annually
Merle D'Aubigne score	Annually
Radiographic analysis	Annually
Kaplan-Meier Survivorship - Revision of any component for any reason	Throughout Study

Collaborators and Investigators

• Sponsor: DePuy International

Study record dates

Study Major Dates

• Study Start: October 1, 2002
• Primary Completion (Actual): October 1, 2005
• Study Completion (Actual): October 1, 2005

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 21, 2005

Study Record Updates

• Last Update Posted (Actual): March 28, 2017
• Last Update Submitted That Met QC Criteria: March 27, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Hip; Cement
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Physiological Effects of Drugs; Vasodilator Agents; Protective Agents; Antimutagenic Agents; Polymethyl Methacrylate
• Other Study ID Numbers: CT02/08