THA: Stem migration and bone loss similar in cementless vs. cemented femoral components .
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(6):26 Acta Orthop. 2012 Dec;83(6):592-8. doi: 10.3109/17453674.2012.742393. Epub 2012 Nov 151 patients, including 52 hips, undergoing treatment for osteoarthritis were randomized to receive either reverse hybrid (cemented polyethylene cup with cementless femoral stem) or conventional cemented total hip replacement (both components cemented) to determine if there was a difference in outcome between the techniques. Clinical outcome, wear, component migration and bone remodeling were recorded over 2 years postoperatively. The results showed that there were no major differences between the two procedures. This study indicated that the reverse hybrid procedure does not provide improved outcomes when compared to the conventional cemented method in total hip replacement.
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.
1/4
Randomization
3/4
Outcome Measurements
2/4
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
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?
The Swedish Hip Arthroplasty and Norwegian Arthroplasty Registers have shown increased use of reverse hybrid technique (cemented polyethylene cup with cementless femoral stem) in total hip replacement. This is in part is due to the observed improvement in survivability of the cementless stems with respect to component loosening. However, there has been concern regarding polyethylene wear induced by hydroxyapatite (HA) in HA-coated implants, commonly seen in reverse hybrid total hip replacements. Also, there has not been a study conducted that has shown that the reverse hybrid technique is superior to conventional cemented total hip replacement, indicating the need for this study.
Qual era la domanda di ricerca principale?
Does the reverse hybrid total hip replacement technique provide superiority to conventional cemented total hip replacement with respect to clinical results, wear, remodeling of the bone, component migration, or component loosening after 2 years?
- Similar improvements in Harris hip and Oxford hip scores were observed in both groups.
- There were no significant differences observed between groups in the amount of wear in the x- (p=0.9), y- (p=0.9), and z-axes (p=0.08), and the vectorial resultant 3D wear (p=0.7).
- Cup and stem component migration in any direction (x-, y-, or z-axes) were observed to not significantly differ between groups.
- Rotation of stem component did not significantly differ between groups. Rotation of cup component in the y- and z-axes was not significantly different between groups. Rotation of the cup component in the x-axis was -0.24 degrees (95%CI -0.55 to 0.07) in the RH group and 0.13 degrees (95%CI -0.08 to 0.34) and in the cemented group, resulting in significant difference (p=0.03).
- Bone remodeling around the cup was found to be similar between groups.
- Significant bone loss in Gruen Zone 1 of the femur was observed in the RH group (18%, 95%CI 11-24%) when compared to the cemented group (1.4%, 95%CI -3.2-5.9%) (p<0.001). Bone loss in remaining Gruen zones (2-7) was not significant between groups.
- There were no significant differences between groups for incidence of component loosening (p>0.05).
Che cosa devo ricordare di più?
The use of a cementless stem in total hip replacement provided similar results to a cemented stem with regards to Harris hip and Oxford hip scores, wear, component migration/rotation, bone remodelling, and bone loss after 2 years. Although significantly higher bone loss in Gruen Zone 1 was associated with the cementless stems, it is unlikely that it is an important clinical finding due to the long-term survivability of the cementless stems.
Come influenzerà l'assistenza ai miei pazienti?
There are no major differences between a cementless and a cemented femoral stem in total hip arthroplasty after 2 years. An extended study with a longer follow-up period is necessary to investigate any differences that may exist between the two techniques.
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