ARTHROPLASTY
Mobile- vs. fixed-bearing total knee replacement
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2015;3(12):8 Acta Orthop. 2015 Apr;86(2):208-1463 patients with uni- or bilateral osteoarthritis were randomized to 2 groups that underwent mobile-bearing (MB) total knee arthroplasty (TKA) or fixed-bearing (FB) TKA. Over a 2 year follow-up period, total translation (TT) via radiostereometric analysis (RSA), bone mineral density (BMD), correlation between implant migration and BMD, and Oxford knee scores (OKS) were evaluated. Results indicated that FB tibial implants migrated a significantly greater degree than MB implants. Within both groups, the majority of migration occurred within the first 3 months after surgery. Both groups displayed similar loss of BMD, which did not correlate to implant migration. OKS was significantly increased in both groups, with no significant between-group differences observed.
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。
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
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？
Mobile-bearing (MB) total knee arthroplasty (TKA) devices have been developed with the theoretical advantages related to contact stress, wear, and loosening of components, although the expected advantages of MB TKA have not been established in prior trials. It has previously been indicated that MB and fixed-bearing (FB) implant designs perform equally well, and thus it is unclear whether MB TKA provides any significant benefit over FB designs. Hence, the purpose of this study was to compare MB and FB designs by investigating implant migration, periprosthetic bone mineral density (BMD) and patient reported outcomes at 2 years for the posterior cruciate ligament (PCL) retaining press-fit condylar (P.F.C) TKA.
主な研究課題は何ですか？
Do mobile-bearing designs improve tibial component fixation compared to fixed-bearing designs in total knee arthroplasty patients, assessed at 3, 6, 12, and 24-months follow-up?
重要な知見は？
- Total translational migration (TT) was significantly higher in the FB group (24-months mean = 0.30 mm +/- 0.22) than the MB group (24-month mean = 0.17 mm +/- 0.09) at all 4 follow-up times (24 months, p= 0.04). Migration predominantly occurred within the first 3 months postoperatively in both groups.
- Excessive migration (>0.2mm) between the 12 and 24 month follow-up periods was noted in two knees of each group.
- Total rotational migration (TR) was similar between groups at all 4 follow-up times (24 months, p= 0.1)
- The maximum total point motion (MTPM) was not significantly different between the FB group (24-month mean = 0.69 mm +/- 0.37) and the MB group (24-month mean = 0.55 mm +/- 0.28) at all follow-up times (p= 0.1)
- Percent BMD loss on anterior/posterior images was a mean -8.8% at 12 months (p=0.04) and -0.8% at 24 months (p=0.4) in the MB group, and -2.3% (p=0.02) and -1.1% (p=0.4), respectively, in the FB group. Percent BMD loss on lateral images was a mean -11.8% at 12 months (p<0.01) and -6.2% at 24 months (p<0.01) in the MB group, and -11.5% (p<0.01) and -4.1% (p=0.1), respectively, in the FB group.
- No correlation was noted between total translation and the change in BMD for either group at 24-month follow-up
- Both groups demonstrated a significant increase in OKS scores between baseline and 6-month follow-up, and maintained through to 24 month follow-up. There were no significant between-group differences in OKS score at either the 6, 12, or 24-month follow-up periods.
最も覚えておくべきことは？
In total knee arthroplasty, total translational migration of cruciate-retaining, fixed-bearing tibial implants was significantly greater than that of cruciate-retaining, mobile-bearing tibial implants, that majority of which occurred within the first 3 months postoperatively in both groups. Both groups displayed similar bone mineral density loss over 24 months, and no significant correlation between migration and BMD loss was observed. Both tibial implants led to significant, and similar, increase in clinical scores.
それが私の患者ケアにどのように影響するか？
Despite the difference between fixed- and mobile-bearing tibial implants in migration, total migration was low in both groups, and relatively unchanged past 3 months. Thus the decision between fixed- and mobile-bearing is still open for discussion, as the current results depict good fixation with similar clinical scores within the first 2 years after surgery. Future studies should analyze stability between implants over the longer term, providing a more accurate look at implant survivorship and longevity.
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