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

Arthritis Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00837850
• Other study ID #: 094-02
• Status: Completed
• Phase: N/A
• First received: February 4, 2009
• Last updated: August 25, 2011
• Start date: October 2002
• Est. completion date: October 2008

Study information

• Verified date: August 2011
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 2008
• Est. primary completion date: October 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 78 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis

Intervention

Device:
• Bone cement 1
Bone cement SmartSet® HV
• Bone cement 2
Bone cement Palacos R

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	DePuy International

References & Publications (1)

Husby OS, Haugan K, Benum P, Foss OA. A prospective randomised radiostereometric analysis trial of SmartSet HV and Palacos R bone cements in primary total hip arthroplasty. J Orthop Traumatol. 2010 Mar;11(1):29-35. doi: 10.1007/s10195-010-0087-x. Epub 201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distal migration of the charnley femoral stem		2010	Yes
Secondary	Rotational movements of the charnley femoral stem		2010	Yes