Altun Müjgan Yilmaz, Flivik Gunnar, Lind Thomas, Odgaard Anders, Holm Christina Enciso, Petersen Michael Mørk
Department of Orthopaedic Surgery, University Hospital of Copenhagen, Rigshospitalet, Copenhagen, Denmark.
Department of Orthopaedic Surgery, University Hospital of Copenhagen, Herlev-Gentofte Hospital, Gentofte Hospitalsvej 1, Hellerup, Denmark.
J Bone Joint Surg Am. 2025 Jul 29;107(17):1926-1939. doi: 10.2106/JBJS.24.00835.
Aseptic loosening remains a main complication following total knee arthroplasty (TKA), requiring revision surgery. Radiostereometric analysis (RSA) can assess the risk of aseptic loosening. This study evaluated the migration and segmental motion of cemented and uncemented femoral and asymmetrical tibial Persona components (Zimmer Biomet) with model-based RSA.
We conducted a randomized controlled trial with 63 patients (22 male patients and 41 female patients, with a mean age of 62 years) and compared patients who underwent TKA with cemented and uncemented Persona components. The primary outcome measure was the maximal total point motion (MTPM) after 2 years. The Mann-Whitney U test was used to compare groups. Migration was visualized by plotting the mean and 95% confidence interval (CI).
After 3 months, femoral components demonstrated an MTPM of 0.41 mm (95% CI, 0.35 to 0.48 mm) in the cemented group and 0.65 mm (95% CI, 0.50 to 0.80 mm) in the uncemented group. Subsequently, a stabilization occurred, and the MTPM after 24 months was 0.51 mm (95% CI, 0.41 to 0.61 mm) in the cemented group and 0.83 mm (95% CI, 0.65 to 1.02 mm) in the uncemented group. There was a significant difference between fixation types at 3 months (p = 0.04), 6 months (p = 0.03), 12 months (p = 0.02), and 24 months (p = 0.02). At 3 months postoperatively, the tibial component demonstrated an MTPM of 0.70 mm (95% CI, 0.53 to 0.88 mm) in the cemented group and 0.76 mm (95% CI, 0.61 to 0.91 mm) in the uncemented group. A stabilization was then observed, and migration after 24 months was 0.72 mm (95% CI, 0.55 to 0.89 mm) for cemented components and 0.78 mm (95% CI, 0.64 to 0.92) for uncemented components.
TKA with cemented and uncemented Persona components showed migration values within acceptable ranges, suggesting successful long-term fixation; however, significant differences in mean MTPM between cemented and uncemented femoral components were found.
Therapeutic Level I . See Instructions for Authors for a complete description of levels of evidence.
无菌性松动仍是全膝关节置换术（TKA）后的主要并发症，需要进行翻修手术。放射立体测量分析（RSA）可评估无菌性松动的风险。本研究采用基于模型的RSA评估骨水泥型和非骨水泥型股骨假体以及不对称胫骨Persona假体（捷迈邦美公司）的移位和节段运动情况。
我们对63例患者（22例男性患者和41例女性患者，平均年龄62岁）进行了一项随机对照试验，比较接受骨水泥型和非骨水泥型Persona假体TKA的患者。主要结局指标为2年后的最大总点运动（MTPM）。采用Mann-Whitney U检验比较各组。通过绘制均值和95%置信区间（CI）来观察移位情况。
3个月时，骨水泥型组股骨假体的MTPM为0.41 mm（95%CI，0.35至0.48 mm），非骨水泥型组为0.65 mm（95%CI，0.50至0.80 mm）。随后出现稳定，24个月时骨水泥型组的MTPM为0.51 mm（95%CI，0.41至0.61 mm），非骨水泥型组为0.83 mm（95%CI，0.65至1.02 mm）。在3个月（p = 0.04）、6个月（p = 0.03）、12个月（p = 0.02）和24个月（p = 0.02）时，固定类型之间存在显著差异。术后3个月，骨水泥型组胫骨假体的MTPM为0.70 mm（95%CI，0.53至0.88 mm），非骨水泥型组为0.76 mm（95%CI，0.61至0.91 mm）。随后观察到稳定情况，24个月时骨水泥型假体的移位为0.72 mm（95%CI，0.55至0.89 mm），非骨水泥型假体为0.78 mm（95%CI，0.64至0.92）。
使用骨水泥型和非骨水泥型Persona假体的TKA显示移位值在可接受范围内，提示长期固定成功；然而，发现骨水泥型和非骨水泥型股骨假体的平均MTPM存在显著差异。
治疗性I级。有关证据水平的完整描述，请参阅作者须知。
