A Randomised Single Centre Study to Compare the Long-term Performance of Acryloc™ and Palacos® R Bone Cements in Primary Total Hip Replacement
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Distal migration of the femoral prosthesis from the time of implantation to the 2 year follow-up assessment [2 Year]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or female subjects, aged 60 to 75 years (inclusive), and with a weight of less than 100kg.
-
Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
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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.
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Subjects with non-inflammatory arthritis of the hip.
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Subjects who require a primary total hip arthroplasty and are treated at the arthroplasty section of the orthopaedics department at the Investigational Centre.
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Subjects who are considered suitable for a cemented femoral stem and cemented acetabular component.
Exclusion Criteria:
-
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.
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Women who are pregnant.
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Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.
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Subjects who have participated in a clinical study with an investigational product in the last 6 month(s).
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Subjects who are currently involved in any injury litigation claims.
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Subjects undergoing corticosteroid treatment.
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Subjects with any condition for whom the use of conventional bone cement is contra-indicated.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital of Trondheim | Trondheim | Sor-Trondelag | Norway |
Sponsors and Collaborators
- DePuy International
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CT02/08