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Smaller migration with monoblock versus modular tibial component in uncemented TKA
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ARTHROPLASTY
Smaller migration with monoblock versus modular tibial component in uncemented TKA .

OrthoEvidence Journal (OE Journal) - ACE Report

OE Journal. 2017;5(15):5 Acta Orthop. 2016 Dec;87(6):607-614

67 patients scheduled for total knee arthroplasty were randomized to receive either a monoblock or modular tibial component. Patients were assessed for component migration over the first 24 months postoperatively, as well as clinical scores in the same time frame. Results demonstrated significantly lower maximum total point motion in the monoblock group compared to the modular group after 24 months. As well, single dimension migration demonstrated significantly lower subsidence in the monoblock group compared to the modular group. Clinical scores did not significantly differ between groups.


Dettagli sul finanziamento della pubblicazione +
Finanziamento:
Industry funded
Sponsor:
Zimmer; Gentofte Hospital, Copenhagen (non-industry)
Conflicts:
None disclosed

Rischio di pregiudizio

5,5/10

Criteri di segnalazione

16/20

Indice di fragilità

N/A

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)?

Sì = 1

Incerto = 0,5

Non rilevante = 0

No = 0

La valutazione dei criteri di segnalazione valuta la trasparenza con cui gli autori riportano le caratteristiche metodologiche e sperimentali dello studio all'interno della pubblicazione. La valutazione è suddivisa in cinque categorie che vengono presentate di seguito.

4/4

Randomization

3/4

Outcome Measurements

3/4

Inclusion / Exclusion

2/4

Therapy Description

4/4

Statistics

Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65

L'Indice di Fragilità è uno strumento che aiuta l'interpretazione dei risultati significativi, fornendo una misura della forza di un risultato. L'Indice di Fragilità rappresenta il numero di eventi consecutivi che devono essere aggiunti a un risultato dicotomico per rendere il risultato non più significativo. Un numero piccolo rappresenta un risultato più debole, mentre un numero grande rappresenta un risultato più forte.

Perché questo studio era necessario ora?

Aseptic loosening of tibial components remains a primary concern regarding the overall survivorship of total knee arthroplasty implants. Polyethylene wear has been identified as a potential contributor to aseptic loosening. Recently, there has been debate whether tibial component designs, specifically monoblock versus modular polyethylene components, may differ in their respective wear and migration profiles.

Qual era la domanda di ricerca principale?

In total knee arthroplasty, does the use of a monoblock tibial component result in significantly lower component migration within the first 2 years postoperatively when compared to a modular polyethylene component?

Caratteristiche dello studio +
Population:
67 patients, under the age of 70, scheduled for total knee arthroplasty due to osteoarthritis were included. All cases were performed using an uncemented, cruciate-retaining NexGen total knee system (Zimmer) with a cemented, all-poly patellar component.
Intervention:
Monoblock group: Patients received the monoblock NexGen Trabecular Metal technology tibial component. Tantalum markers were inserted in the tibial bone and polyethylene portion of the tibial component to facilitate radiostereometric analysis (RSA) during follow-up. (33 randomized; 26 analyzed) (Mean age: 62 [47-70])
Comparison:
Modular group: Patients received the modular NexGen Trabecular Metal technology tibial component. Tantalum markers were inserted in the tibial bone and polyethylene portion of the tibial component to facilitate RSA during follow-up. (n=34 randomized; 27 analyzed) (Mean age: 61 [44-70])
Outcomes:
The primary outcome was tibial component migration measured via maximum total point motion on RSA. Secondary outcomes included tibial component translation and rotation individually in the x-, y- and z-axes, and clinical outcome via the Knee Society Score and EuroQoL 5-dimension questionnaire (EQ-5D).
Methods:
RCT
Time:
Follow-up was scheduled for 3, 6, 12, and 24 months postoperatively.
Quali erano i risultati importanti?
  • There was no significant difference in MTPM between the monoblock group and the modular group after 3 months (0.58mm [95%CI 0.43-0.72] vs. 0.85mm [0.65-1.09]; p=0.2) or 6 months (0.66mm [0.44-0.77] vs. 0.98mm [0.74-1.26];p=0.1); MTPM was significantly lower in the monoblock group compared to the modular group at 12 months (0.65mm [0.46-0.78] vs. 1.01mm [0.81-1.28]; p=0.02) and 24 months (0.72mm [0.53-0.82 vs. 1.15mm [0.90-1.37]; p=0.02).
  • In individual axes for translation, no significant differences between groups in anterior-posterior translation or lateral-medial translation of the tibial component were noted at any follow-up. In contrast, beginning at 6 months, significantly smaller superior-inferior translation of the tibial component was observed in the monoblock group compared to the modular group, and significance was maintained after 24 months (-0.18mm [-0.24, -0.07] vs. -0.38mm [-0.54, -0.23]; p=0.02).
  • In individual axes for rotation, no significant differences between groups were observed in either anterior-posterior tilt, varus-valgus tilt, or internal-external rotation of the component at any follow-up time point (all p>0.05).
  • No significant differences between groups were observed in Knee Society Knee scores, Knee Society Function scores, or EQ-5D scores at any follow-up time point (all p>0.05).
Che cosa devo ricordare di più?

In uncemented total knee arthroplasty, the use of a monoblock tibial component was associated with significantly smaller maximum total point motion after 24 months, and, specifically, significantly lower superior-inferior translation of the tibial component after 24 months when compared to a modular polyethylene tibial component. No significant between-group differences were noted in x- and z-axis translation of the component, x-, y, and z-axis rotation of the component, or clinical scores after 24 months.

Come influenzerà l'assistenza ai miei pazienti?

The results of this study suggest that monoblock tibial components may result in a statistically significantly smaller degree of migration, as assessed via maximum total point motion, from 12 to 24 months after uncemented total knee arthroplasty when compared to modular polyethylene tibial components. Nonetheless, there did not appear to be any clinical impact of the difference observed between groups within this time frame. Follow-up studies are needed to determine if the observed difference in migration has any implication on the incidence of aseptic loosening and component survivorship in the long-term.

DISCLAIMER

Il contenuto di questa pagina è solo a scopo informativo e non intende sostituire la consulenza, la diagnosi o il trattamento medico professionale. Se ha bisogno di cure mediche, si rivolga sempre al suo medico o al pronto soccorso più vicino. Le opinioni, le convinzioni e i punti di vista espressi dalle persone sui contenuti presenti in questa pagina non riflettono le opinioni, le convinzioni e i punti di vista di OrthoEvidence.

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OrthoEvidence. Smaller migration with monoblock versus modular tibial component in uncemented TKA. OE Journal. 2017;5(15):5. Available from: https://myorthoevidence.com/AceReport/Show/

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