Reif Taylor J, Geffner Adam, Hoellwarth Jason S, Fragomen Austin T, Rozbruch S Robert
Department of Limb Lengthening and Complex Reconstruction, Hospital for Special Surgery, New York, United States of America.
Department of Orthopedic Surgery, Hospital for Special Surgery, New York, United States of America.
Strategies Trauma Limb Reconstr. 2023 May-Aug;18(2):94-99. doi: 10.5005/jp-journals-10080-1514.
The Precice Stryde® internal magnetic lengthening nail allowed many patients a full weight-bearing experience during femur and tibia lengthening, but concerns over corrosion, pain and radiographic changes led to the implant's recall. Despite the recall, it is important to understand the rate of these occurrences and their influence on the overall success of the lengthening procedure. We aimed to investigate radiographic changes, patient-reported symptoms and bone healing indices for our cohort of Stryde lengthening.
Our surgical database and electronic medical record system were used to review and document patient demographics, indications for lengthening, length achieved, bone healing index (BHI), location and type of radiographic changes, time until radiographic changes were first visible, presence of pain symptoms (not attributable to surgery or distraction), time to implant removal and if the pain symptoms resolved following implant extraction.
From January 2019 to February 2021, 90 Stryde nails (78 femur and 12 tibia) were implanted in 63 patients. The cohort included 48 males and 15 females. The average length [± standard deviation (SD)] achieved was 58.4 ± 22.7 mm. The 66 bones (73%) developed radiographic changes and were found to be 58/78 (74%) femurs and 8/12 (67%) tibias. The average time to initial radiographic changes was 168 ± 108.1 days (femur) and 276 ± 126.8 days (tibia). Late-onset pain developed in 10 femur lengthening (11.1% of all nails) surgeries across eight patients (12.7% of all patients). All patients' pain resolved; three instances prior to nail removal and the remaining seven after nail removal. No patients were re-presented with worsening pain or radiographic changes following implant removal. Radiographic or symptomatic abnormalities did not impair bone formation. The BHI for femurs with (29.6 ± 16.6 days/cm, = 58) vs without (29.4 ± 17.9 days/cm, = 20) radiographic or symptomatic irregularity were nearly identical ( = 0.961). The difference between BHI for tibias with (39.3 ± 7.8 days/cm, = 8) vs without (86.1 ± 38.2 days/cm, = 4) radiographic changes was influenced by outliers and underpowered to draw a conclusion.
Bone lengthening with the Stryde nail was associated with high rates of radiographic abnormalities, but symptoms were uncommon and resolved with explantation. The radiographic changes did not affect bone healing in the femur.
Radiographic changes including bone hypertrophy and osteolysis were common after bone lengthening with the Stryde nail, but the development of pain following consolidation was rare and resolved with implant removal.The BHI in femurs was not affected by radiographic changes.
Reif TJ, Geffner A, Hoellwarth JS, Precice Stryde® Magnetic Internal Lengthening Nail does not Impair Bone Healing Despite Radiographic and Clinical Symptoms. Strategies Trauma Limb Reconstr 2023;18(2):94-99.
Precice Stryde® 磁性髓内延长钉使许多患者在股骨和胫骨延长过程中能够完全负重,但对腐蚀、疼痛和影像学改变的担忧导致该植入物被召回。尽管已被召回,但了解这些情况的发生率及其对延长手术总体成功率的影响很重要。我们旨在研究Stryde延长患者队列的影像学改变、患者报告的症状和骨愈合指标。
我们使用手术数据库和电子病历系统来回顾和记录患者的人口统计学资料、延长指征、延长长度、骨愈合指数(BHI)、影像学改变的位置和类型、首次出现影像学改变的时间、疼痛症状(非手术或牵张引起)的存在情况、取出植入物的时间以及植入物取出后疼痛症状是否缓解。
2019年1月至2021年2月,63例患者植入了90枚Stryde钉(78枚股骨钉和12枚胫骨钉)。该队列包括48名男性和15名女性。平均延长长度[±标准差(SD)]为58.4±22.7mm。66根骨头(73%)出现了影像学改变,其中58/78(74%)为股骨,8/12(67%)为胫骨。首次出现影像学改变的平均时间为168±108.1天(股骨)和276±126.8天(胫骨)。8例患者(占所有患者的12.7%)的10例股骨延长手术(占所有钉子的11.1%)出现了迟发性疼痛。所有患者的疼痛均得到缓解;3例在取出钉子前缓解,其余7例在取出钉子后缓解。取出植入物后,没有患者出现疼痛加重或影像学改变。影像学或症状异常并未损害骨形成。有影像学或症状异常的股骨BHI(29.6±16.6天/厘米,n = 58)与无异常的股骨BHI(29.4±17.9天/厘米,n = 20)几乎相同(P = 0.961)。有影像学改变的胫骨BHI(39.3±7.8天/厘米,n = 8)与无影像学改变的胫骨BHI(86.1±38.2天/厘米,n = 4)之间的差异受异常值影响,样本量不足无法得出结论。
使用Stryde钉进行骨延长与影像学异常的高发生率相关,但症状并不常见,取出植入物后症状缓解。影像学改变并未影响股骨的骨愈合。
使用Stryde钉进行骨延长后,包括骨肥大和骨质溶解在内的影像学改变很常见,但愈合后疼痛的发生很少见,取出植入物后疼痛缓解。股骨的BHI不受影像学改变的影响。
Reif TJ, Geffner A, Hoellwarth JS, Precice Stryde®磁性髓内延长钉尽管有影像学和临床症状但不损害骨愈合。创伤肢体重建策略2023;18(2):94 - 99。