C. H. Shin, W. J. Yoo, I. H. Choi, T.-J. Cho, Division of Pediatric Orthopaedics, Seoul National University Children's Hospital, Seoul, Republic of Korea D. J. Lee, Department of Orthopaedic Surgery, Kangwon National University Hospital, Chuncheon, Republic of Korea.
Clin Orthop Relat Res. 2018 Nov;476(11):2238-2246. doi: 10.1097/CORR.0000000000000429.
Interlocking telescopic rods for the management of osteogenesis imperfecta (OI)-related long bone fractures are a modification of the Sheffield rod. An interlocking pin anchors the obturator at the distal epiphysis, which spares the distal joint, while a T-piece anchors the sleeve at the proximal epiphysis. However, these devices are associated with some problems, including failure to elongate and difficulty with removal. A dual interlocking telescopic rod (D-ITR), in which the sleeve and the obturator are anchored with interlocking pins, was developed to address these problems.
QUESTIONS/PURPOSES: In this study, we compared the D-ITR with an older version of a single interlocking telescopic rod (S-ITR) based on (1) surgery-free survival and rod survival; (2) cessation of rod elongation and elongated length of the rod; and (3) risk of refracture and complications related to the interlocking telescopic system.
This article compares the D-ITR with the S-ITR using a historically controlled, single-surgeon, retrospective design comparing two implants for the management of fractures in children with OI. Before August 2007, we exclusively used the S-ITR (n = 17 patients, 29 tibiae); from July 2008 until October 2014, we exclusively used the D-ITR (n = 17 patients, 26 tibiae). During the 1-year transition period, we performed five of these procedures (two S-ITR in two patients and three D-ITR in three patients), and implant use was based on availability with our preference being the D-ITR during that time when it was available. The general indications for use of both devices were the same: patients with OI and a tibial fracture who were older than 3 to 4 years of age and whose tibial canals were wide enough to accept an intramedullary rod. Younger patients were treated other ways (generally without surgery) and those with narrower canals with thinner, nonelongating rods or Kirschner wires, as indicated. All patients in both groups were available for followup at a minimum of 2 years (mean ± SD, 9.6 ± 3.0 years in the S-ITR group and 5.3 ± 2.1 years in the D-ITR group) except for one patient in the D-ITR group who died > 1 year after the procedure resulting from reasons unrelated to it. For the between-group comparison, we used only the followup data collected up to the ninth postoperative year in the S-ITR group. The truncated followup period of the S-ITR group was a mean of 5.0 ± 1.6 years. The mean age in the S-ITR group was 7 years (range, 3-12 years) and it was 8 years (range, 3-14 years) in the D-ITR group. There were nine boys and 10 girls in each group. Two orthopaedic surgeons other than the operating surgeon performed chart review to address our three research purposes. Survival analyses were performed using the Kaplan-Meier method. The overall pooled risk of refracture and major complications potentially associated with the interlocking telescopic rod system was compared between the groups.
With the numbers available, there were no differences between the D-ITR and the S-ITR in terms of mean surgery-free survival time (5.7 [95% confidence interval {CI}, 4.5-6.9] versus 5.1 [95% CI, 4.1-6.1]; years; p = 0.653) or mean rod survival time (7.4 [95% CI, 6.4-8.4] versus 6.0 [95% CI, 5.1-6.9] years; p = 0.120). With the numbers available, cessation of elongation (4% in the D-ITR group versus 19% in the S-ITR group; p = 0.112) and elongated length (45.3 ± 24.3 mm in the D-ITR group versus 44.2 ± 22.3 mm in the S-ITR group; p = 0.855) also did not differ between the groups. The pooled proportions of refracture or complications after the index surgery were higher in the S-ITR group (25 tibias [81%]) than in the D-ITR group (15 tibias [54%]; p = 0.049). Eight tibias in the S-ITR group had proximal migration of the sleeve compared with no patients in the D-ITR group (p = 0.005).
In patients with OI, the modified D-ITR provides effective tibial stabilization with similar or better results than the S-ITR design. Anchoring the sleeve at the proximal epiphysis with an interlocking pin provides better anchorage and allows easier removal.
Level III, therapeutic study.
用于治疗成骨不全症(OI)相关长骨骨折的交锁伸缩棒是 Sheffield 棒的改良版。一个锁定销将堵塞器固定在远端骨骺,从而保留远端关节,而 T 型件将套管固定在近端骨骺。然而,这些设备存在一些问题,包括无法延长和难以取出。为了解决这些问题,开发了一种双交锁伸缩棒(D-ITR),其中套管和堵塞器通过锁定销固定。
问题/目的:在这项研究中,我们根据(1)无手术生存和棒生存;(2)停止延长和延长棒的长度;以及(3)再骨折风险和与交锁伸缩系统相关的并发症,比较了 D-ITR 和较旧的单交锁伸缩棒(S-ITR)。
本文使用历史对照、单外科医生、回顾性设计比较了两种植入物治疗儿童 OI 骨折的情况。在 2007 年 8 月之前,我们专门使用 S-ITR(n = 17 例患者,29 胫骨);从 2008 年 7 月到 2014 年 10 月,我们专门使用 D-ITR(n = 17 例患者,26 胫骨)。在 1 年的过渡期间,我们进行了其中的 5 次手术(2 例 S-ITR 中有 2 例患者,3 例 D-ITR 中有 3 例患者),并且根据可用性选择植入物,我们当时的偏好是在可用时使用 D-ITR。两种设备的一般适应证相同:年龄大于 3 至 4 岁且胫骨管足够宽以容纳髓内棒的 OI 患者和胫骨骨折患者。较年轻的患者接受了其他治疗(通常无需手术),而管腔较窄的患者则使用较细的、非延长的棒或克氏针治疗,具体情况视需要而定。两组中的所有患者均至少随访 2 年(S-ITR 组的平均随访时间为 9.6 ± 3.0 年,D-ITR 组的平均随访时间为 5.3 ± 2.1 年),除了一名 D-ITR 组患者在手术后 1 年以上死亡,死亡原因与手术无关。对于组间比较,我们仅使用 S-ITR 组在术后第 9 年收集的随访数据。S-ITR 组的截断随访期平均为 5.0 ± 1.6 年。S-ITR 组的平均年龄为 7 岁(范围为 3-12 岁),D-ITR 组为 8 岁(范围为 3-14 岁)。两组各有 9 名男孩和 10 名女孩。两名骨科医生除了手术医生外,还进行了图表审查,以解决我们的三个研究目的。使用 Kaplan-Meier 方法进行生存分析。比较两组之间与交锁伸缩系统相关的再骨折和主要并发症的总风险。
根据现有的数据,D-ITR 与 S-ITR 在无手术生存时间(5.7 [95%置信区间 {CI},4.5-6.9]与 5.1 [95% CI,4.1-6.1]年;p = 0.653)或棒生存时间(7.4 [95% CI,6.4-8.4]与 6.0 [95% CI,5.1-6.9]年;p = 0.120)方面没有差异。根据现有的数据,停止延长(D-ITR 组 4%,S-ITR 组 19%;p = 0.112)和延长长度(D-ITR 组 45.3 ± 24.3 mm,S-ITR 组 44.2 ± 22.3 mm;p = 0.855)在两组之间也没有差异。S-ITR 组索引手术后再骨折或并发症的累积比例(25 胫骨 [81%])高于 D-ITR 组(15 胫骨 [54%];p = 0.049)。S-ITR 组有 8 胫骨套管近端迁移,而 D-ITR 组无患者发生这种情况(p = 0.005)。
在 OI 患者中,改良的 D-ITR 提供了有效的胫骨稳定,结果与 S-ITR 设计相似或更好。用锁定销将套管固定在近端骨骺可提供更好的固定,并便于取出。
III 级,治疗性研究。