No difference between Cemex Rx and Palacos R for THR .
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(6):15 Acta Orthop. 2012 Dec;83(6):604-8. doi: 10.3109/17453674.2012.742392. Epub 2012 Nov 1.44 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.
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)?
Ja = 1
Ungewiss = 0.5
Nicht relevant = 0
Nein = 0
Die Bewertung der Berichtskriterien bewertet die Transparenz, mit der die Autoren die methodischen und studienspezifischen Merkmale der Studie in der Veröffentlichung angeben. Die Bewertung ist in fünf Kategorien unterteilt, die im Folgenden vorgestellt werden.
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
Der Fragilitätsindex ist ein Instrument, das bei der Interpretation signifikanter Ergebnisse hilft und ein Maß für die Stärke eines Ergebnisses liefert. Der Fragilitätsindex gibt die Anzahl der aufeinanderfolgenden Ereignisse an, die zu einem dichotomen Ergebnis hinzugefügt werden müssen, damit das Ergebnis nicht mehr signifikant ist. Eine kleine Zahl steht für ein schwächeres Ergebnis und eine große Zahl für ein stärkeres Ergebnis.
Warum wurde diese Studie jetzt benötigt?
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.
Was war die wichtigste Forschungsfrage?
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?
- 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.
Was sollte ich mir besonders merken?
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.
Wie wird sich dies auf die Behandlung meiner Patienten auswirken?
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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