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临床试验/NCT03470623
NCT03470623Unknown不适用

Randomized, Prospective Comparison of Bioabsorbable and Steel Screw for the Treatment of Hallux Valgus With Chevron Osteotomy

Second Hospital of Jilin University0 个研究点目标入组 50 人开始时间: 2018年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
主要终点
American orthopedic foot and ankle society forefoot score change

研究概览

简要总结

Hallux valgus is the most common deformity of forefoot and the patients would suffer pain and disable of walking and wearing normal shoes. Chevron osteotomy of the first metatarsal is widely used for the treatment of mild or medium hallux valgus. It is a "V" sharp osteotomy that can decrease the intermetatarsal degree of first-second metatarsal by pushing the distal side of osteotomy laterally.A 2.5mm or 3.0mm steel cannulated screw is usually used for the fixation of the osteotomy side to provide stability.However,there are some shortcomings of steel screws such as rejection of internal fixation or the financial cost of the second surgery of fixation taken-out. To obviate these shortcomings of steel screws, bioabsorbable screw fixation may be an alternative method for chevron osteotomy.

This trial is a randomized, prospective, controlled, parallel experimental design, to compare the clinical and radiographic outcomes of bioabsorbable screw versus steel screw for the treatment of hallux valgus with chevron osteotomy. The patients will be randomized to two groups, one treated with bioabsorbable screws while the other treated with steel screws.Data collection for the outcomes measures will occur pre-op,immediate post-op and then 6 weeks, 12 weeks, and at 1 years post operation.

The clinical outcomes measure are the VAS (visual analogue scale) score and AOFAS (American orthopedic foot and ankle society) forefoot score.The radiographic outcomes measures are the IMA (intermetatarsal angle) and the HVA (hallux valgus angle)

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • hallux valgus treated with distal chevron osteotomy
  • age between 18-70

排除标准

  • hallux valgus treated with other procedure (scarf,ludloff,lapidus,etc)
  • age <18 or age >70
  • osteoporosis -

结局指标

主要结局

American orthopedic foot and ankle society forefoot score change

时间窗: pre-op,6 weeks,12 weeks and 1 year after operation

American orthopedic foot and ankle society forefoot score was consist of "pain","ability of walking" and "alignment".The minimum score is 0 and the maximum score is 100, "0"means worst while "100" means best of the outcome. It was used as a standard evaluation method of hallux valgus.

次要结局

  • VAS score(pre-op,6 weeks,12 weeks and 1 year after operation)
  • Radiographic outcomes parameters(pre-op,6 weeks,12 weeks and 1 year after operation)

研究者

发起方
Second Hospital of Jilin University
申办方类型
Other
责任方
Sponsor

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