THA: No difference between low-profile cup and Standard cup in terms of migration and wear .
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(11):93 Acta Orthop. 2007 Aug;78(4):479-8460 patients with primary osteoarthritis awaiting total hip replacement, from ages 60-80 years, were randomized to either receive THR using a low-profile Lubinus Flanged Anti-Luxation Cup (FAL) or the Lubinus Standard Eccentric cup. The results at 3 years indicated that there no difference between the Lubinus FAL cup and the Lubinus Standard cup with respect to migration and wear.
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.
3/4
Randomization
2/4
Outcome Measurements
4/4
Inclusion / Exclusion
4/4
Therapy Description
3/4
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?
In total hip replacement procedures, a higher degree of containment within the bony acetabulum is achieved with low-profile acetabular components. Incidence of radioluency and wear may be reduced with the complete bony containment of cups. The low-profile design allows for greater range of free motion before femoral neck and cup impingement occurs. However, in contrast, the low-profile cups result in decreased containment of the prosthetic head within the cup therefore increasing the risk of instability or dislocation. It was reported that use of the SHP (low-profile) cup resulted in increased migration and wear, at the same time as the Lubinus Flanged Anti-Luxation Cup (FAL) was being introduced. This resulted in the need to compare this FAL low-profile cup to Standard cups, in order to examine the safety of the FAL cup and it's effects of migration and wear.
Was war die wichtigste Forschungsfrage?
How does the low-profile Lubinus Flanged Anti-Luxation Cup (FAL) compare to the Lubinous Standard Eccentric cup, in terms of the effects on migration and wear, in patients with primary osetoarthritis undergoing total hip replacement, measured at a 3 year follow up period?
- There was no difference in cup migration (MTPM values) between the two groups (p=0.7 at 1 year, p=0.8 at 3 years).
- There was no difference between groups in terms of wear (p=0.9 at 1 year, p=0.7 at 3 years).
- The clinical results (WOMAC, VAS rest, VAS activity) were excellent, with no significant differences between both groups (all p>0.05).
- 3 cups (2 FAL, 1 Standard) reported increased proximal migration that indicated an increased risk of early loosening.
- No correlation was observed between migration and wear.
Was sollte ich mir besonders merken?
There was no significant difference between The Lubinus FAL cup and the Lubinus Standard cup, in terms of migration and wear, measured at 1 and 3 years following surgery. Clinical outcomes were equally favorable in both groups.
Wie wird sich dies auf die Behandlung meiner Patienten auswirken?
In patients where a low-profile cup is acceptable and suitable, this study indicates that the FAL cup is safe and effective for patients undergoing total hip replacement. Further high-quality evidence with larger sample sizes is needed to evaluate the safety and efficacy of this novel implant.
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