Jonker Leon, Fallahi Farshid, Saraswathy Jayadeep J, Edge John, Dawson Matt
1 Cumbria Partnership NHS Foundation Trust, Research & Development Department, Carlisle, UK.
2 North Cumbria University Hospitals NHS Trust, Orthopaedics & Radiology Department, Carlisle, Cumbria, UK.
J Orthop Surg (Hong Kong). 2019 Sep-Dec;27(3):2309499019864721. doi: 10.1177/2309499019864721.
The objective was to evaluate the clinical and patient-related short- to medium-term performance of the OPTY-LINE nail device for high tibial osteotomy (HTO), comparing a case series of the said device to the established Tomofix fixed-plate device.
Males with symptomatic medial compartmental osteoarthritis and no serious (co-morbid) knee pathology were followed up, five Tomofix and six OPTY-LINE patients. Patients underwent computed tomography assessment and completed Knee Injury and Osteoarthritis Outcome score (KOOS) and osteotomy surgery patient satisfaction questionnaires, 3 and 6 months post-surgery. A radiologist impression score and a quantitative digital bone density analysis were performed by two independent radiologists. Mann-Whitney test was applied for inferential statistical tests.
At 6 months post-surgery, for Tomofix, the median radiologists' healing impression score was 'progressive healing' versus 'union virtually complete' for the OPTY-LINE nail; bone healing quotient was 1.30 (standard deviation (SD) 1.74) versus 1.78 (SD 1.58), = 0.18. The post-operative absolute surgical accuracy was a mean 12 (7.5) for Tomofix versus 4.1 (2.3) for OPTY-LINE, = 0.052. At baseline, however, Tomofix patients had more knee symptoms, as determined by KOOS symptom sub-score, when compared to the OPTY-LINE cohort ( = 0.009).
This initial, non-randomized, comparative evaluation of the OPTY-LINE device for HTO has produced similar outcomes to patients treated with the established Tomofix device. In particular, the rate of post-surgical bone regeneration and surgical accuracy achieved with the OPTY-LINE device are encouraging. Large-scale randomized controlled studies with longer follow-up are indicated to further evaluate the clinical and patient-related outcome performance for OPTY-LINE.
本研究旨在评估用于高位胫骨截骨术（HTO）的OPTY-LINE髓内钉装置的临床及患者相关的短期至中期性能，并将该装置的病例系列与成熟的Tomofix固定板装置进行比较。
对有症状的内侧间室骨关节炎且无严重（共病）膝关节病变的男性患者进行随访，其中5例使用Tomofix装置，6例使用OPTY-LINE装置。患者在术后3个月和6个月接受计算机断层扫描评估，并完成膝关节损伤和骨关节炎疗效评分（KOOS）以及截骨手术患者满意度问卷。由两名独立的放射科医生进行放射科医生印象评分和定量数字骨密度分析。采用曼-惠特尼检验进行推断性统计分析。
术后6个月，对于Tomofix装置，放射科医生的愈合印象评分中位数为“进行性愈合”，而OPTY-LINE髓内钉为“几乎完全愈合”；骨愈合商数分别为1.30（标准差（SD）1.74）和1.78（SD 1.58），P = 0.18。术后绝对手术精度方面，Tomofix装置平均为12（7.5），而OPTY-LINE装置为4.1（2.3），P = 0.052。然而，在基线时，根据KOOS症状子评分，Tomofix装置的患者比OPTY-LINE队列有更多的膝关节症状（P = 0.009）。
对用于HTO的OPTY-LINE装置进行的这项初步、非随机的比较评估，其结果与使用成熟的Tomofix装置治疗的患者相似。特别是，OPTY-LINE装置实现的术后骨再生率和手术精度令人鼓舞。需要进行大规模、随访时间更长的随机对照研究，以进一步评估OPTY-LINE装置的临床及患者相关结局表现。
