Implant migration reduced in hydroxyapatite coated versus uncoated components .
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OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(1):6 Acta Orthop. 2012 Apr;83(2):135-41. doi: 10.3109/17453674.2012.665330. Epub 2012 Feb 13Exclusive Author Interview
Dr. B.G. Pijls speaks on the long term beneficial effect of hydroxyapatite in TKA.
48 patients (68 knees) scheduled for total knee arthroplasty were randomized to receive a cemented, cementless non-coated, or cementless hydroxyapatite (HA)-coated tibial component to determine the effect of HA on long-term migration of the prosthesis. Radiostereometric analyses (RSA), Knee Society Scores, Hospital for Special Surgery scores, and radiographic evaluation were recorded over 16 years. The results indicated that migration of HA-coated components was improved compared to non-coated components, but increased in comparison to cemented components.
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.
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Randomization
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Outcome Measurements
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Inclusion / Exclusion
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Therapy Description
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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?
Although the beneficial early fixation properties of hydroxyapatite (HA) coatings on cementless prosthetic components in total knee arthroplasty have been extensively studied and researched, reports of the long-term migration of HA-coated components are limited. Moreover, complications of delamination and third-body wear associated with the HA-coating have been reported in total hip arthroplasty, which could cause long-term problems.
Was war die wichtigste Forschungsfrage?
Does HA-coating maintain fixation properties and reduce migration of components in total knee arthroplasty over the long-term (11 to 16 years) when compared to uncoated components and cemented components?
- Migration of the HA-coated tibial components was less than the non-coated components (MD 0.39mm, 95%CI 0.16-0.62)
- HA-coated components were observed to have significantly greater migration compared to cemented components (MD 0.61mm, 95%CI 0.42-0.80, p<0.001)
- HA-coating decreased subsidence by 0.26mm (95%CI 0.10-0.42) and external rotation by 0.47 degrees (95%CI 0.27-0.67) when compared to non-coated components.
- There was no significant difference observed between groups in clinical outcomes of KSS and HSS at 10 years postoperatively.
- The groups did not significantly differ in radiographic assessments of FTA, alpha, beta, and delta angles of components.
- 49 of the operated knees underwent TKA as a result of rheumatoid arthritis, 18 due to osteoarthritis, and 1 because of sequelae after septic arthritis.
- Longitudinal follow-up of TKA with RSA allowed for early detection of secondary loosening.
Was sollte ich mir besonders merken?
The use of HA-coating on cementless components for total knee arthroplasty decreased prosthesis migration significantly, when compared to non-coated cementless components. However, an increase in migration was observed when HA-coated components were compared to cemented components.
Wie wird sich dies auf die Behandlung meiner Patienten auswirken?
HA-coating of cementless tibial components can reduce long-term migration compared to non-coated cementless components. However, cemented components appear to provide the greatest reduction in migration. Further research is required to confirm these findings in studies using larger sample sizes and a more balanced population (equal number of patients requiring treatment due to rheumatoid arthritis, osteoarthritis and other disorders).
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