PRECICE延长钉取出后的功能测试：“休眠”钉概念
Post-retrieval functionality testing of PRECICE lengthening nails: The "Sleeper" nail concept.
作者信息
Eltayeby Hady H, Alrabai Hamza M, Jauregui Julio J, Shabtai Lior Y, Herzenberg John E
机构信息
International Center for Limb Lengthening, Rubin Institute for Advanced Orthopedics, Sinai Hospital of Baltimore, Baltimore, MD, USA.
Department of Orthopedics, Alexandria University, Alexandria, Egypt.
出版信息
J Clin Orthop Trauma. 2020 Jun 24;14:151-155. doi: 10.1016/j.jcot.2020.06.005. eCollection 2021 Mar.
INTRODUCTION
PRECICE intramedullary magnetic lengthening nails, introduced in 2011, have changed the landscape of long bone limb lengthening. The implants have a stroke ranging from 5 to 8 cm, but it may be desirable to perform part of the lengthening at one treatment, allow bone healing, leave the implant in place, dormant, and then return one or more years later to re-lengthen with the same implant. We call this the "sleeper" nail concept. This strategy may be gentler for the joints and soft tissues. Would the nail mechanism still be functional one or more years later?
METHODS
We tested 102 intact, consecutively explanted nails. Using a "fast magnet," the male part was lengthened to 5 mm short of its maximum stroke capacity and retracted back to 35 mm (all nails start with the male part exposed 30 mm). The nails passed the test if the male part succeeded in lengthening to 5 mm short of the maximum stroke capacity and back to 35 mm (or only retract in case fully deployed at testing). During our testing, the nails were prevented from reaching their full capacity of lengthening/retraction to avoid jamming the gears. Failure was defined as the inability or partial ability to complete the process.
RESULTS
Eighty-six nails (84.3%) performed successfully according to our testing standard. When comparing successful and failed nails in terms of nail type, generation, diameter, length and in vivo interval, there was no statistical significance. Comparing both groups in terms of status at testing (fully deployed or not) showed statistical significance with 9 of the 16 failed nails fully deployed at testing (p < 0.001).
CONCLUSION
Dormant PRECICE nails can be reactivated for further lengthening. The results imply that full deployment may damage the mechanism, making future re-use by retracting and then re-lengthening unsuccessful. The candidate nails for this purpose should not have any signs of clear damage (bending or breakage) and should not have been fully deployed. However, surgeons and patients should be aware of the need for possible nail exchange if the "sleeper" nail fails to wake up.
LEVEL OF EVIDENCE
Level IV case series analysis of retrieved surgical implants.
引言
2011年推出的PRECICE髓内磁控延长钉改变了长骨肢体延长的局面。该植入物的行程为5至8厘米，但可能希望在一次治疗中进行部分延长，让骨骼愈合，将植入物留在原位处于休眠状态，然后在一年或多年后再用同一植入物进行再次延长。我们将此称为“休眠”钉概念。这种策略对关节和软组织可能更温和。一年或多年后钉的机制仍会起作用吗？
方法
我们测试了102枚完整的、连续取出的钉子。使用“快速磁铁”，将阳型部件延长至比其最大行程能力短5毫米，然后缩回至35毫米（所有钉子开始时阳型部件伸出30毫米）。如果阳型部件成功延长至比最大行程能力短5毫米并缩回至35毫米（或在测试时已完全展开则仅缩回），则钉子通过测试。在我们的测试过程中，防止钉子达到其延长/缩回的最大能力，以避免齿轮卡住。失败定义为无法或部分无法完成该过程。
结果
根据我们的测试标准，86枚钉子（84.3%）成功通过测试。在按钉子类型、代次、直径、长度和体内间隔比较成功和失败的钉子时，没有统计学意义。按测试时的状态（是否完全展开）比较两组显示有统计学意义，16枚失败的钉子中有9枚在测试时已完全展开（p<0.001）。
结论
休眠的PRECICE钉可重新激活以进行进一步延长。结果表明完全展开可能会损坏机制，导致未来通过缩回然后再次延长进行再次使用不成功。用于此目的的候选钉子不应有任何明显损坏（弯曲或断裂）的迹象，且不应已完全展开。然而，外科医生和患者应意识到如果“休眠”钉无法“唤醒”，可能需要更换钉子。
证据水平
对取出的手术植入物进行的IV级病例系列分析。
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