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临床试验/NCT04145882
NCT04145882进行中(未招募)不适用

Is it Better to Add Supination Osteotomy, Varisation Osteotomy, or Both to Distal Chevron as Part of Hallux Valgus Management : a Prospective Randomized Trial

Elsan8 个研究点 分布在 1 个国家目标入组 515 人开始时间: 2019年9月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
515
试验地点
8
主要终点
Rate of patients having both Hallux Valgus Angle >15° and InterMetatarsal Angle >10°

研究概览

简要总结

Deviation of the big toe in valgus at the level of the first metatarsophalangeal joint is called Hallux Valgus. In case of significant pain especially due to a conflict with the shoes, surgery could be indicated. Angle between the first metatarsal (M1) and the first phalangeal (P1) is named Hallux Valgus Angle (HVA). Angle between M1 and the second metatarsal (M2) is named InterMetatarsal Angle (IMA). Angle between M1 distal articular surface and M1 shaft axis in a frontal plane is named Distal Metatarsal Articular Angle (DMAA).

Insufficient surgical correction is a risk factor of recurrence (HVA>20° after surgery). According to Okuda et al in a 67 patients group treated by proximal osteotomies correction, postoperative risk factors of recurrence at 33 month of follow-up are : HVA>40° before the surgery and HVA>15° with an IMA>10° 10 weeks (3-24) after the surgery.

Currently, one of the most common used procedure is a translated (laterally) distal chevron associated with a release of the metatarso-sesamoid suspensory ligament and a Akin procedure on P1. Nevertheless this procedure does not correct deformation in all plans. HVA and IMA are corrected but DMAA and M1 pronation angle are not.

Surgeons can add three different osteotomies in this type of chevron. In the dorsal saw cut a varisation wedge osteotomy is possible , in the plantar saw cut a supination wedge osteotomy is possible, and both are possible. No studies have tried to assess these three possibilities.

The investigators hypothesize that the addition of a varisation and/or a supination wedge osteotomies in a distal chevron decrease risk factors of recurrence at six months of follow-up

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient older than 18 years.
  • Informed consent

排除标准

  • Associated lesser metatarsals surgery.
  • Associated surgery on midfoot, hindfoot or ankle.
  • Neurologic diseases (Charcot Marie Tooth disease, poliomyelitis, compartment syndrome sequelae)
  • Clinical or X-ray degenerative signs (Hallux rigidus) or irreducible deformations (MTP1 arthrodesis indications).
  • Patient who declined the study.

研究组 & 干预措施

both (varisation + supination) osteotomies addition.

Experimental

干预措施: additional osteotomies (Procedure)

No additional osteotomy

Active Comparator

干预措施: additional osteotomies (Procedure)

varisation osteotomy addition

Experimental

干预措施: additional osteotomies (Procedure)

supination osteotomy addition

Experimental

干预措施: additional osteotomies (Procedure)

结局指标

主要结局

Rate of patients having both Hallux Valgus Angle >15° and InterMetatarsal Angle >10°

时间窗: 6 months

on weight bearing X-Rays

次要结局

  • Recurrence of hallux valgus (HVA>20°).(5 years)
  • American Orthopedic Foot and Ankle Forefoot Score (AOFAS)(5 years)
  • Patient satisfaction (Likert scale)(5 years)

研究者

发起方
Elsan
申办方类型
Other
责任方
Sponsor

研究点 (8)

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