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临床试验/NL-OMON54817
NL-OMON54817招募中不适用

ateral ligament repair for ankle instability protected with internal bracing. A multicenter, randomized controlled trial. - the STRONG-study

Sint Annaziekenhuis0 个研究点目标入组 42 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
42

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
16 至 64(—)

入选标准

  • - Male or female patient diagnosed with chronic lateral ankle instability
  • (multiple ankle inversion trauma within 12 months and symptoms present >1
  • year). Lateral ankle instability is present if the patient complains of giving
  • way of the ankle and has positive signs of ankle instability during physical
  • exam (talar tilt score of >15 degrees compared to contralateral ankle or
  • anterior drawer test score of >10mm compared to the contralateral ankle.
  • - Conservative therapy has failed.
  • - Normal foot and ankle anatomy as determined by orthopedic surgeon.
  • - Patients in whom their ankle symptoms interfere with their physical
  • activities.
  • - Patients between the age of 18 and 60 years.
  • - Patients with isolated anterior talofibular ligament which is indicated for
  • repair using the Brostrom-Gould technique.
  • - BMI <=30
  • - Patients who are able and willing to undergo ankle surgery.
  • - Patients who are able and willing to comply with the rehabilitation protocol
  • in any of the study physiotherapy centers.
  • - Patients who are able and willing to return for follow-up evaluations.
  • - Patients with sufficient understanding of the Dutch language.

排除标准

  • - Patients who need concomitant ankle surgery (i.e. Calcaneofibular ligament
  • reconstruction, peroneus tendon repair, arthroscopy of the ankle, etc).
  • - Patients with comorbidities, including musculoskeletal injuries or diseases
  • in other joints than the affected ankle which limits their physical activity.
  • - Ankle instability due to abnormal foot and ankle anatomy.
  • - No objective or subjective ankle instability.
  • - Previous ankle surgery.
  • - Patients in which the contralateral ankle also shows lateral ankle
  • instability.

研究者

发起方
Sint Annaziekenhuis

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