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临床试验/DRKS00019009
DRKS00019009招募中未知

The effect of an educational, autonomous and everyday therapeutic approach on the surgical decision and the functional outcome after 3, 12 and 24 months in persons with hallux valgus and a given surgical indication - a randomized, controlled intervention study. - The F.O.O.T-Study (Functional Operative Orthopaedic Therapy Study)

Spiraldynamik Holding AG0 个研究点目标入组 150 人开始时间: 2019年11月20日最近更新:
适应症

试验速览

阶段
未知
状态
招募中
发起方
入组人数
150

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized controlled study
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 79 Years(—)
性别
All

入选标准

  • Signed Informed Consent
  • - Age 20 to 79 years
  • - Hallux valgus foot deformity with/without metatarsalgia eligible for surgical correction of foot deformity
  • - Surgery can wait for at least 12 Weeks
  • - Interested in participating in the study and willing to filling out questionnaires at 4 time points (0, 3, 12, 24 months)
  • - German language capability oral and written
  • - No cognitive dysfunction

排除标准

  • - Morton (pseudo) neuroma
  • - Hallux rigidus or advanced arthrosis of the great toe joint (Art. Metatarsophalangealis 1 (MTP1)) in hallux valgus
  • - Dislocated toe joints MTP 2-5; mechanical arthropathy
  • - Rheumatoid arthritis
  • - mid- or rearfoot pain (e.g. Fasciitis, achillodynia)
  • - neuropathic foot pain (e.g. Polyneuropathy, diabetic)
  • - Currently tumor, fracture, trauma to the foot
  • - Condition after forefoot surgery on the affected side
  • - severe gait disability
  • - Known psychiatric condition
  • - Anamnestic confirmation of pregnancy (-> women)

研究者

发起方
Spiraldynamik Holding AG

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