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Similar migration & wear of an all-poly press-fit cup with and without screw stabilization
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ARTHROPLASTY
Similar migration & wear of an all-poly press-fit cup with and without screw stabilization .
Verified
This report has been verified by one or more authors of the original publication.

OrthoEvidence Journal (OE Journal) - ACE Report

OE Journal. 2016;4(22):2 Acta Orthop. 2016 Aug;87(4):363-7
Autores colaboradores

MJ Minten PJ Heesterbeek M Spruit

36 patients who had undergone total hip arthroplasty and completed a 2-year follow-up of a previous randomized controlled trial were invited and included in this follow-up extension. Patients had received a press-fit, all-polyethylene acetabular cup, and had been randomized to placement with or without additional screw fixation. Radiostereometric analysis was performed to assess component migration and wear over 6.5-year follow-up, and the Harris Hip Score and Oxford Hip Score were used to assess clinical outcome. No significant differences were observed between groups in total 3-dimensional translation or rotation of the acetabular component. There were also no significant differences between groups in the total overall and corrected 3-dimensional wear or overall & corrected wear rates.


Detalles de la financiación de la publicación +
Financiación:
Industry funded
Patrocinador:
Mathys Orthopaedics
Conflicts:
None disclosed

Riesgo de sesgo

6/10

Criterios de información

10/20

Índice de fragilidad

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)?

Sí = 1

Incierto = 0,5

No relevante = 0

No = 0

La evaluación de los criterios de información evalúa la transparencia con la que los autores informan de las características metodológicas y del ensayo dentro de la publicación. La evaluación se divide en cinco categorías que se presentan a continuación.

1/4

Randomization

3/4

Outcome Measurements

0/4

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

El Índice de Fragilidad es una herramienta que ayuda en la interpretación de hallazgos significativos, proporcionando una medida de fuerza para un resultado. El Índice de Fragilidad representa el número de eventos consecutivos que es necesario añadir a un resultado dicotómico para que el hallazgo deje de ser significativo. Un número pequeño representa un hallazgo más débil y un número grande un hallazgo más fuerte.

¿Por qué se necesitaba ahora este estudio?

Press-fit fixation of acetabular cups is often used in total hip arthroplasty. A debate has emerged surrounding the use of additional fixation screws in press-fit acetabular cups. While improved short-term stability may occur, there is concern that long-term stability could be compromised through various mechanisms, such as stress-shielding and wear. However, there is a current lack of evidence from randomized controlled trials to recommend either the use or avoidance of additional screw fixation with press-fit acetabular cups.

¿Cuál era la pregunta principal de la investigación?

In total hip arthroplasty, is there any significant difference in cup migration, cup wear, and clinical outcome of a cementless all-polyethylene acetabular cup with and without screw fixation, assessed over a 6.5-year follow-up?

Características del estudio +
Population:
36 patients who had undergone total hip arthroplasty as part of a previous trial, and who had completed 2-year follow-up were included. All cases were performed through a posterolateral approach with standardized components across group: RM press-fit all-polyethylene acetabular cup (Mathys AG) with a cementless Spotorno femoral stem (Zimmer) and 32mm ceramic femoral head. Six tantalum markers were inserted into the acetabular component preoperatively, and a minimum of an additional six tantalum markers were inserted into the acetabular bone intraoperatively to facilitate radiosterometric analysis during follow-up.
Intervention:
Screw group: The acetabular component was additionally stabilized using two 4.0mm screws. (n=17; 15 analyzed)
Comparison:
No screw group: No additional stabilization of the acetabular component was used. (n=19; 12 analyzed)
Outcomes:
Radiostereometric analysis (RSA) was performed to calculate three-dimensional translation and rotation of the acetabular cup. RSA was additionally used to assess implant wear, defined as the translation of the femoral head in relation to the acetabular cup in all three planes. Total wear and wear rate were calculated, both as raw data as well as corrected for initial bedding-in over the first postoperative year. Additionally, the incidence of clinically relevant translation (>1mm) and clinically relevant rotation (>2 degrees) was assessed. Clinical outcome was assessed through the Harris Hip Score and the Oxford Hip Score. Device-related adverse events were also documented.
Methods:
RCT; single-center
Time:
Follow-up scheduled at 1, 2, and 6 years. Median follow-up was 6.4 and 6.3 years, respectively.
¿Cuáles fueron los hallazgos importantes?
  • There was no significant difference between the screw group and no screw group in either total 3-dimensional translation (p=0.8) or total 3-dimensional rotation (p=0.2).
  • Between-group differences in individual planes were non-significant, with the exception of medial-lateral rotation: mean rotation was 0.33deg (+/-0.50) in the screw group and -0.61deg (+/-0.97) in the no screw group (p=0.004).
  • There were two cases of clinically relevant rotation of the acetabular component in each group. The same two cases in the no screw group also demonstrated clinically relevant translation of the acetabular component.
  • There was no significant difference in total wear over 6-year follow-up between the screw group (0.57+/-0.24mm) and the no screw group (0.53+/-0.20mm) (p=0.6). The only plane which demonstrated a significant difference between groups was medial-lateral wear (Screws: 0.19+/-0.22mm | No screws: -0.04+/-0.12mm | p=0.003).
  • Corrected wear analysis, which accounted for the large degree of wear within the first year after surgery, demonstrated similar results to the overall analysis.
  • Overall wear rate over 6 years did not significantly differ between the screw group (0.09+/-0.04 mm/year) and the no screw group (0.08+/-0.03 mm/year) (p=0.7). Corrected wear rate also did not significantly differ between groups (0.07+/-0.04 vs. 0.09+/-0.04 mm/year; p=0.3).
  • No significant difference between groups was noted either HHS (p=0.6) or OHS (p=0.6).
¿Qué es lo que más debo recordar?

In total hip arthroplasty with a press-fit acetabular cup, there were no significant differences in total 3-dimensional translation or rotation of the acetabular cup after 6.5 years, as assessed with RSA, with or without additional screw stabilization. There were also no significant differences in RSA-assessed component wear or clinical outcome after 6 years.

¿Cómo afectará esto al cuidado de mis pacientes?

The results of this study suggest that additional screw stabilization of cementless, press-fit all-polyethylene acetabular cup in total hip arthroplasty does not confer any significant mid-term advantage in migration, component wear, or clinical outcome over cups placed without additional stabilization.

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OrthoEvidence. Similar migration & wear of an all-poly press-fit cup with and without screw stabilization. OE Journal. 2016;4(22):2. Available from: https://myorthoevidence.com/AceReport/Show/similar-migration-wear-of-an-all-poly-press-fit-cup-with-and-without-screw-stabilization

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