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超声限制成像协议在发育性髋关节发育不良帕夫利克吊带监测中的应用(TULIPPS):一项随机对照试验。

Testing of an Ultrasound-Limited Imaging Protocol for Pavlik harness Supervision (TULIPPS) in developmental dysplasia of the hip: a randomized controlled trial.

机构信息

Department of Surgery, University of Toronto, Toronto, Canada.

Division of Orthopaedic Surgery, The Hospital for Sick Children, Toronto, Canada.

出版信息

Bone Joint J. 2022 Sep;104-B(9):1081-1088. doi: 10.1302/0301-620X.104B9.BJJ-2022-0350.R2.

Abstract

AIMS

There is no consensus regarding optimum timing and frequency of ultrasound (US) for monitoring response to Pavlik harness (PH) treatment in developmental dysplasia of the hip (DDH). The purpose of our study was to determine if a limited-frequency hip US assessment had an adverse effect on treatment outcomes compared to traditional comprehensive US monitoring.

METHODS

This study was a single-centre noninferiority randomized controlled trial. Infants aged under six months whose hips were reduced and centred in the harness at initiation of treatment (stable dysplastic or subluxable), or initially decentred (subluxated or dislocated) but reduced and centred within four weeks of PH treatment, were randomized to our current standard US monitoring protocol (every clinic visit) or to a limited-frequency US protocol (US only at end of treatment). Groups were compared based on α angle and femoral head coverage at the end of PH treatment, acetabular indices, and International Hip Dysplasia Institute (IHDI) grade on one-year follow-up radiographs.

RESULTS

Overall, 100 patients were included; 42 patients completed the standard protocol (SP) and 40 completed the limited protocol (LP). There was no significant difference in mean right α angle at the end of treatment (SP 70.0° (SD 3.2°) ; LP 68.7° (SD 2.9°); p = 0.033), nor on the left (SP 69.0° (SD 3.5°); LP 68.1° (SD 3.3°); p = 0.128). There was no significant difference in mean right acetabular index at follow-up (SP 23.1° (SD 4.3°); LP 22.0° (SD 4.1°); p = 0.129), nor on the left (SP 23.3° (SD 4.2°); LP 22.8° (SD 3.9°); p = 0.284). All hips had femoral head coverage of > 50% at end of treatment, and all were IHDI grade 1 at follow-up. In addition, the LP group underwent a 60% reduction in US use once stable.

CONCLUSION

Our study supports reducing the frequency of US assessment during PH treatment of DDH once a hip is reduced and centred.Cite this article:  2022;104-B(9):1081-1088.

摘要

目的

目前对于发育性髋关节发育不良(DDH)患儿使用 Pavlik 吊带(PH)治疗的疗效监测,尚无最佳的超声(US)检查时机和频率的共识。本研究旨在确定与传统全面 US 监测相比,有限频率的髋关节 US 评估是否会对治疗结果产生不利影响。

方法

本研究为单中心非劣效性随机对照试验。在治疗开始时(稳定型发育不良或半脱位)髋关节已复位且髋臼包容良好,或最初髋关节失稳(半脱位或脱位)但在 PH 治疗 4 周内已复位且髋臼包容良好的月龄在 6 个月以下的婴儿,随机分为接受我们目前标准的 US 监测方案(每次就诊时)或有限频率 US 方案(仅在治疗结束时进行 US)。根据 PH 治疗结束时的 α 角和股骨头覆盖率、髋臼指数以及 1 年随访时的国际髋关节发育不良协会(IHDI)分级,对两组进行比较。

结果

共纳入 100 例患者,其中 42 例完成标准方案(SP),40 例完成有限方案(LP)。治疗结束时,右侧 α 角的均值无显著差异(SP:70.0°(SD:3.2°);LP:68.7°(SD:2.9°);p = 0.033),左侧也无显著差异(SP:69.0°(SD:3.5°);LP:68.1°(SD:3.3°);p = 0.128)。随访时右侧髋臼指数的均值也无显著差异(SP:23.1°(SD:4.3°);LP:22.0°(SD:4.1°);p = 0.129),左侧也无显著差异(SP:23.3°(SD:4.2°);LP:22.8°(SD:3.9°);p = 0.284)。所有髋关节在治疗结束时股骨头覆盖率均>50%,且所有髋关节在随访时均为 IHDI 1 级。此外,LP 组髋关节一旦稳定,US 检查次数减少 60%。

结论

本研究支持一旦髋关节复位且髋臼包容良好,可减少 DDH 患儿使用 PH 治疗期间的 US 评估频率。

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