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

Primary Purpose

Osteoarthritis, Post-traumatic Arthritis, Avascular Necrosis

Status
Terminated
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Acryloc™ GHV
Palacos R
Sponsored by
DePuy International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Hip, Cement

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy 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.

Sites / Locations

  • University Hospital of Trondheim

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Acryloc™ GHV

Palacos R

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 13, 2005
Last Updated
March 27, 2017
Sponsor
DePuy International
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1. Study Identification

Unique Protocol Identification Number
NCT00208403
Brief Title
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

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Study Start Date
October 2002 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
October 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DePuy International

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Post-traumatic Arthritis, Avascular Necrosis
Keywords
Hip, Cement

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Acryloc™ GHV
Arm Title
2
Arm Type
Active Comparator
Arm Description
Palacos R
Intervention Type
Device
Intervention Name(s)
Acryloc™ GHV
Intervention Description
A high viscosity bone cement for use in total hip replacement
Intervention Type
Device
Intervention Name(s)
Palacos R
Intervention Description
A high viscosity bone cement for use in total hip replacement
Primary Outcome Measure Information:
Title
Distal migration of the femoral prosthesis from the time of implantation to the 2 year follow-up assessment
Time Frame
2 Year
Secondary Outcome Measure Information:
Title
Annual posterior (AP) and medio-lateral (ML) RSA translations
Time Frame
Annually
Title
Merle D'Aubigne score
Time Frame
Annually
Title
Radiographic analysis
Time Frame
Annually
Title
Kaplan-Meier Survivorship - Revision of any component for any reason
Time Frame
Throughout Study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
University Hospital of Trondheim
City
Trondheim
State/Province
Sor-Trondelag
Country
Norway

12. IPD Sharing Statement

Learn more about this trial

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

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