Higher flexion devices in TKA have no effect on patient-perceived outcomes .
This report has been verified
by one or more authors of the
original publication.
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(8):8 BMC Musculoskelet Disord. 2013 Apr 8;14(1):127. doi: 10.1186/1471-2474-14-12736 patients undergoing a one-stage bilateral total knee arthroplasty were randomized to receive standard cruciate-retaining (CR) TKA in one knee and high-flex posterior-stabilized (PS) TKA in the other. This trial was designed to investigate whether higher flexion had an effect on patient perceived outcomes. 1 year results through Visual Analogue Scale and Short Form-36 survey indicated no differences in ability to perform daily activities, satisfaction, “feel” of the knee, or pain in either prosthesis.
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)?
Sim = 1
Incerto = 0,5
Não relevante = 0
Não = 0
A Avaliação dos Critérios de Relato avalia a transparência com que os autores relatam as caraterísticas metodológicas e do ensaio na publicação. A avaliação está dividida em cinco categorias que são apresentadas de seguida.
3/4
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
O Índice de Fragilidade é uma ferramenta que auxilia na interpretação de achados significativos, fornecendo uma medida de força para um resultado. O Índice de Fragilidade representa o número de eventos consecutivos que precisam de ser adicionados a um resultado dicotómico para que o resultado deixe de ser significativo. Um número pequeno representa um resultado mais fraco e um número grande representa um resultado mais forte.
Porque é que este estudo era necessário agora?
In total knee arthroplasty, range of motion is considered to be a measurement of functional success. New high flex prosthetic designs have been used, but studies have not been able to show that increased flexion beyond 110 degrees have an influence on patient-perceived outcomes. This trial, therefore, aimed to investigate whether insertion of high flex posterior stabilized TKA had increased patient satisfaction, reduced pain, better “feel” and better abilities in activities of daily living compared to standard cruciate retaining prosthesis.
Qual era a principal questão de investigação?
Does higher knee flexion, provided by high-flex PS-TKA, affect patient-perceived outcomes, such as pain, satisfaction, ability to perform daily tasks, and "feel" of the knee at 1 year, compared to standard CS-TKA?
- PS TKA and CR TKA had similar mean maximum active and passive flexion preoperatively, at week 6 and 3 months. However, at 6 months and 1 year, PS TKA had significantly better flexion (p<0.05). By final follow up, 30 of the CR TKA’s and 31 of the high-flex PS TKA’s were able to extend to 0–5 degrees (P>0.05)
- VAS knee pain was similar in both types of TKA at all-time points (P>0.05).
- VAS satisfaction did not differ between PS TKA and CR TKA at all-time points (P>0.05)
- Patient perceived “feel” of the knee was reported to be the same at all-time points between the knees (P>0.05)
- Satisfaction in ROM during activities of daily living, biking, squatting, facing barriers, were stated to be similar in both prosthesis (P>0.05)
- For SF-36, 26/33 patients who completed questionnaire had comparable median physical component score (PCS) of 47.8 (range: 20.6-57.9) and median mental component score (MCS) of 59.2 (range: 32.8-64.6)
De que é que me devo lembrar mais?
Although high flexion PS prosthesis significantly increased flexion at 12 months compared to standard CR prosthesis, it had no significant effect on patient-perceived results, such as pain, satisfaction, "feel" of the knee, and ability to perform daily activities.
Como é que isto afectará o tratamento dos meus doentes?
The findings suggest that increasing flexion beyond 110 degrees through high-flex PS prosthesis does not produce better patient related outcomes in this population. Further studies with larger sample sizes should be conducted to suggest the best prosthesis choice across different populations and activity levels.
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