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

Not Applicable

Completed

• Conditions: Arthritis
• Interventions: Device: Bone cement 1; Device: Bone cement 2

• Registration Number: NCT00837850
• Lead Sponsor: Norwegian University of Science and Technology

Brief Summary

A randomised radiostereometric study comparing SmartSet HV and Palacos R acrylic bone cements.

Detailed Description

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.

Study Timeline

• Study Start: 2002-10
• Primary Completion: 2003-10
• Study Completion: 2008-10
• Study First Submitted: 2009-02-04
• Study First Submitted QC: 2009-02-04
• Study First Posted: 2009-02-05
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-25
• Last Update Posted: 2011-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Bone cement 1	-
2	Bone cement 2	-

Primary Outcome Measures

Name	Time	Method
Distal migration of the charnley femoral stem	2010

Secondary Outcome Measures

Name	Time	Method
Rotational movements of the charnley femoral stem	2010