SmartSet HV and Palacos R RSA Bone Cements in Primary Total Hip Arthroplasty
Primary Purpose
Arthritis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bone cement 1
Bone cement 2
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis focused on measuring total hip arthroplasty, Charnley stem, RSA, non-inflammatory arthritis
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Distal migration of the charnley femoral stem
Secondary Outcome Measures
Rotational movements of the charnley femoral stem
Full Information
NCT ID
NCT00837850
First Posted
February 4, 2009
Last Updated
August 25, 2011
Sponsor
Norwegian University of Science and Technology
Collaborators
DePuy International
1. Study Identification
Unique Protocol Identification Number
NCT00837850
Brief Title
SmartSet HV and Palacos R RSA Bone Cements in Primary Total Hip Arthroplasty
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
October 2003 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
DePuy International
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis
Keywords
total hip arthroplasty, Charnley stem, RSA, non-inflammatory arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Bone cement 1
Other Intervention Name(s)
SmartSet HV
Intervention Description
Bone cement SmartSet® HV
Intervention Type
Device
Intervention Name(s)
Bone cement 2
Other Intervention Name(s)
Palacos R
Intervention Description
Bone cement Palacos R
Primary Outcome Measure Information:
Title
Distal migration of the charnley femoral stem
Time Frame
2010
Secondary Outcome Measure Information:
Title
Rotational movements of the charnley femoral stem
Time Frame
2010
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Otto S. Husby, PhD
Organizational Affiliation
St.Olavs hospital HF
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
20198403
Citation
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 2010 Mar 3.
Results Reference
result
Learn more about this trial
SmartSet HV and Palacos R RSA Bone Cements in Primary Total Hip Arthroplasty
We'll reach out to this number within 24 hrs