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No difference between Cemex Rx and Palacos R for THR
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May 2013
No difference between Cemex Rx and Palacos R for THR
Study Type:Therapy
OE Level Evidence:2
Journal Level of Evidence:N/A
10-year results of a new low-monomer cement follow-up of a randomized RSA study
Acta Orthop. 2012 Dec;83(6):604-8. doi: 10.3109/17453674.2012.742392. Epub 2012 Nov 1.Did you know you're eligible to earn 0.5 CME credits for reading this report? Click Here
Synopsis
44 patients undergoing total hip replacement were randomized to receive a Lubinus SPII titanium-aluminum-vanadium stem cemented either with the new Cemex Rx bone cement or with Palacos R bone cement. The 10 year results of the study indicated that Cemex bone cement performs just as well as Palacos R bone cement.
Publication Funding Details
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Funding:
Non-Industry funded
Sponsor:
IngaBritt and Arne Lundberg Research Foundation, the Doctor Felix Neubergh Foundation, the Swedish Medical Research Foundation
Conflicts:
None disclosed
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
Yes = 1
Uncertain = 0.5
Not Relevant = 0
No = 0
The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.
2/4
Randomization
3/4
Outcome Measurements
1/4
Inclusion / Exclusion
4/4
Therapy Description
4/4
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
The Fragility Index is a tool that aids in the interpretation of significant findings, providing a measure of strength for a result. The Fragility Index represents the number of consecutive events that need to be added to a dichotomous outcome to make the finding no longer significant. A small number represents a weaker finding and a large number represents a stronger finding.
Why was this study needed now?
Enhancements in cementing techniques during cemented total hip arthroplasty have reduced the incidence of early loosening and delayed revision time. However, the curing temperature during the cementing process is believed to cause bone and cell necrosis, which leads to membrane formation and aseptic loosening, a cause for revision. Cemex was designed to reduce the curing temperature by removing the smallest sizes of particles in the polymer powder, which would lead to a smaller surface area reacting with monomers. But, laboratory tests have shown that the curing temperature of Cemex is no different that the curing temperature of conventional Palacos R. This study aimed to determine aimed to examine the clinical properties of Cemex and compare the results with those of Palacos R.
What was the principal research question?
Does Cemex Rx bone cement reduce femoral stem migration and rotation while improving hip pain and function when compared to Palacos R bone cement among total hip replacement patients, 10 years after surgery?
Study Characteristics
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Population:
44 patients undergoing total hip replacement with a Lubinus SPII titanium-aluminum-vanadium stem.
Intervention:
Cemex Rx bone cement.
Comparison:
Palacos R bone cement.
Outcomes:
Femoral stem migration and rotation were assessed using radiostereometric analysis, hip function was assessed using the Harris hip score, pain was assessed using a Visual Analogue Scale (VAS), and radiolucent lines were assessed using radiographic evaluation.
Methods:
RCT: prospective.
Time:
10 years (outcomes assessed 6 months, 1 year, 2 years, 5 years, and 10 years after surgery).
What were the important findings?
- The magnitudes of rotation into flexion/extension and retroversion were significantly larger among the patients that received Palacos bone cement (p=0.005 and 0.01, respectively) but there was no significant difference in rotation around the sagittal axis as most implants were tilted into varus (p=0.7).
- The magnitude of subsidence was similar among the patients that received Palacos bone cement and the patients that received Cemex bone cement (p=0.7).
- There was no significant differences in migration of the femoral component in relation to the cement mantle between the treatment groups. Most migration occurred between the stem and cement mantle in both groups.
- Radiolucent lines along the stem were found in Gruen zones 2 and 6 in 22 cases. The proportion of radiolucent lines in the total interface was 40% for the patients that received Palacos and 50% for the patients that received Cemex.
- There was no significant difference in Harris hip scores and pain scores between the patients that received Cemex bone cement and Palacos bone cement.
What should I remember most?
There was no significant difference in rotation around the sagital axis, the magnitude of subsidence, migration of the femoral component, radiolucent lines, hip function, and pain between the two treatment groups.
How will this affect the care of my patients?
The study suggests that Cemex Rx bone cement will preform similarly to Palacos R bone cement when used for total hip replacements. Further research trials are needed to confirm these findings.
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