ARTHROPLASTY
The effect of different hydroxyapatite application techniques on femoral stem stability .
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2016;4(13):8 Acta Orthop. 2016 Feb;87(1):42-7.50 patients (55 hips) scheduled for primary total hip arthroplasty were randomized to receive implants with hydroxyapatite applied either via electrochemical deposition or plasma-spray. The purpose of this study was to determine whether differences exists between methods with respect to bone density loss, aseptic loosening, periprosthetic migration and functional scores when evaluated up to 5 years post-surgery. Results demonstrated that although patients in the plasma-spray group demonstrated significantly less loss in bone mineral density and decreased retroversion rates at certain time-points, the two methods of hydroxyapatite application were deemed to be clinically comparable.
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
4/4
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?
Fixation of implants following total hip arthroplasty is critically dependent on successful integration between prosthetic and natural surfaces. As such, osseointegrative techniques have been developed in order to ensure implant stability; this includes the application of naturally occurring and bone formation inducing biomaterial such as hydroxyapatite. Hydroxyapatite is normally applied via plasma spray or by electrochemical deposition for the purpose of reducing aseptic loosening and bone resorption, however, there is a lack of clinical evaluation that directly compares the two methods. Thus, the current study was conducted.
Was war die wichtigste Forschungsfrage?
For patients scheduled for total hip arthroplasty, did either hydroxyapatite application accomplished by electrochemical disposition or plasma-spray result in significantly reduced periprosthetic migration and bone resorption, when assessed up to 5 years postoperatively?
- Bone mineral density (BMD) was reported to have declined in all Gruen zones for all patients, with the majority of this bone loss occurring within the first year. After two years, bone loss ranged from 8-14% in zones 2 to 6 and ~30% in zone 7.
- The greatest loss in bone remodeling rate was seen in zone 7 (34% for BM group vs. 31% for HA group) and in zone 1 (20% for BM group vs. 25% for HA group).
- BMD for patients in the BM group decreased by a rate of 0.11%/month (95% CI -0.19 to -0.04), compared to a rate of 0.01%/month (95% CI -0.08 to 0.1) in the HA group; this difference was statistically significant (p=0.04), however, it was determined to be clinically irrelevant.
- Stem subsidence/migration during the first 3 months occurred at comparable rates when study groups were compared (p=0.6); subsidence rates were minuscule when measured after the 3-month time point, with comparable rates once again demonstrated between study groups (p=0.4).
- Rates of retroversion were significantly higher in the first three months for patients in the BM group when compared to the HA group (0.17 degrees/month [0.11-0.23] vs. 0.06 degrees/month [-0.01-0.12] respectively, p=0.006); after the 3-month time point, retroversion rates remained stable and were comparable between study groups (p=0.3).
- HHS and OHS scores were comparable between study groups after 5 postoperative years.
Was sollte ich mir besonders merken?
Bone mineral density loss and retroversion rates in THA patients significantly differed between electrochemical deposition and plasma-spray groups (significance was observed at 3 months for the latter), with less severe rates observed in patients who receive hydroxyapatite application through plasma-spray. However, as all patients and prostheses remained stable throughout the study period the significance was deemed to be clinically insignificant. All other outcomes were comparable when measured at all follow-up points.
Wie wird sich dies auf die Behandlung meiner Patienten auswirken?
The results of this study demonstrated that there were no clinically significant differences between the two methods of hydroxyapatite application five years following total hip arthroplasty. While this study demonstrates no differences between hydroxyapatite application techniques, questions still remain regarding the use of hydroxyapatite and if it provides any clinically relevant advantages.
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