SmartSet HV and Palacos R RSA Bone Cements in Primary Total Hip Arthroplasty

Study Overview
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Brief Summary
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A randomised radiostereometric study comparing SmartSet HV and Palacos R acrylic bone cements.

Detailed Description
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The fixation of components in total hip arthroplasty has a significant effect on the long-term survival of the prostheses. Bone cement in total joint replacement acts as an anchoring medium for the prosthesis and provides a barrier to the ingress of wear debris into bone surfaces. However, there are significant differences in cement behaviour among differing types of cement. A clinical study based on the Norwegian Arthroplasty Register demonstrated that there is an increased rate of revision due to aseptic loosening of femoral components implanted with low-viscosity cement compared with that of high-viscosity. Studies have shown that high early migration for certain designs of femoral prosthesis can be a predictor for clinical loosening. RSA is a technique enabling calculation of the three-dimensional translational and rotational movements of the implant relative to the bone, and therefore provides an ideal technique to detect early micromotion of implants.

Official Title
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A Randomised Prospective Trial of SmartSet HV and Palacos R Bone Cements in Primary Total Hip Arthroplasty. A Radiostereometric Analysis of the Charnley Femoral Component.

Conditions
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Arthritis

Intervention / Treatment
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* Device: Bone cement 1
* Device: Bone cement 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients in need for total hip arthroplasty Exclusion Criteria: patients with an existing condition such as malignancy, pregnancy, severe osteoporosis and disabling musculoskeletal problems (other than in the hips), patients on corticosteroid treatment, patients who had already participated in a clinical study with an investigational product in the last 6 months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 78 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Device: Bone cement 1<br>* Bone cement SmartSet® HV<br>* Other names: SmartSet HV;|
| Active Comparator: 2<br> | Device: Bone cement 2<br>* Bone cement Palacos R<br>* Other names: Palacos R;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distal migration of the charnley femoral stem |  | 2010 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rotational movements of the charnley femoral stem |  | 2010 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total hip arthroplasty, Charnley stem, RSA, non-inflammatory arthritis