ARTHROPLASTY
Trabecular metal in total knee arthroplasty associated with higher knee scores: a randomized controlled trial
This report has been verified
by one or more authors of the
original publication.
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2014;2(3):4 Clin Orthop Relat Res. 2013 Nov;471(11):3543-53145 patients, between the ages of 50 and 70 years, who were admitted for primary TKA and who had moderate to severe femorotibial gonarthrosis were randomly assigned into 1 of 2 groups to compare the efficacy of a tibial component fixed by a porous tantalum system to a conventional cemented implant in terms of clinical outcomes, complications/reoperations, and radiographic results. The findings of the study indicate that at the 5 year follow-up mean KSS and mean WOMAC scores were significantly better in the cementless group when compared to the cemented group. However, no differences in frequency of complications or aseptic loosening between the two groups were found.
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)?
はい = 1
不確実＝0.5
無関係 = 0
いいえ = 0
報告基準評価では、著者が出版物内で試験の方法論的特徴や試験特性を報告する際の透明性を評価します。評価は以下の5つのカテゴリーに分類されます。
4/4
Randomization
4/4
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
Fragility Indexは、重要な所見の解釈を助けるツールで、結果の強さの尺度を提供します。Fragility Indexは、その所見が有意でなくなるために、二項対立の結果に追加する必要がある連続した事象の数を表します。数値が小さいほど弱い所見を表し、数値が大きいほど強い所見を表します。
なぜ今この研究が必要なのですか？
TKA has become a widely accepted procedure for reducing pain and improving function in patients who are experiencing physical limitations of the knee/leg. Currently, cemented TKA is the accepted standard for TKA consistently providing predictable and durable results, but certain restrictions/limitations with this procedure have led to further development of alternative techniques. Cementless fixation seeks to address the common issue of aseptic failure in patients with cemented fixation (especially in younger individuals), and increased durable biological fixation with more physiologic transfer of stress to the underlying bone. Early results with cementless implants showed promising results with achieving these goals, but a wide variety of complications and failures occurred. Tantalum, a newer biomaterial that mimics cancellous bone, may be able to overcome the issues that occurred with previous cementless implants.
主な研究課題は何ですか？
Does a tibial component fixed by a porous tantalum system achieve better clinical outcomes, fewer complications/reoperations, and improved radiographic results when compared to a conventional cemented implant?
重要な知見は？
- Patients who received Cementless tibia implants exhibited improved KSS and WOMAC scores when compared to those who received the cemented implants.
- At 5 year follow up mean KSS score was 90.4 in Group 1 and 86.5 in Group 2, a significant difference in favour of the Cementless group (p=0.02). Effect size at 95% CI for difference between the means was 3.88 +/- 2.87.
- At 5 year follow up the WOMAC mean was 15.1 in Group 1 and 19.1 in Group 2, a significant difference in favour of the Cementless implant group (p=0.02). Effect size at 95% CI for difference between the means was -4.0 +/- 3.9.
- Average KSS and WOMAC scores reported at 6 months and 5 years post operatively were significantly improved from preoperative levels in both groups (p<0.001 at both follow ups for both outcomes)
- No differences between groups in terms of frequency of complications or reoperations were found by final follow up. In total 10% of Group 1 patients and 14% of Group 2 patients underwent additional procedures for complications, most of which were manipulations under anesthesia.
- Radiographic analysis showed no difference in radiologic alignment at 5 years between the groups, and no changes in component position or osteolysis were found during the follow up period. Two patients in group 1 had progressive radiolucent lines under the anterior flange of their femoral component, but zero patients (in either group) experienced progressive radiolucent lines around the tibial component or aseptic loosening.
最も覚えておくべきことは？
At 5 year follow up KSS mean and mean WOMAC scores were significantly better in the cementless group when compared to the cemented group. There were no differences in frequency of complications or aseptic loosening between the two groups.
それが私の患者ケアにどのように影響するか？
The results of the study suggest that there are statistically significant differences between uncemented porous tantalum tibial components and conventional cemented tibial components in terms of knee function score, in favour of uncemented treatment. Further research determining if the difference in results outweighs the cost increase of the cementless treatment is needed.
免責事項
このページに記載されている内容は、情報提供のみを目的としたものであり、専門的な医療アドバイス、診断、治療の代わりとなるものではありません。治療が必要な場合は、必ず医師の診断を仰ぐか、最寄りの救急外来を受診してください。このページに記載されている内容に関して個人が表明した意見、信念、見解は、OrthoEvidenceの意見、信念、見解を反映するものではありません。
0の4 月間無料記事のロック解除
