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临床试验/ACTRN12621001376831
ACTRN12621001376831招募中未知

Streamlining Management And Rehabilitation with Technology for ankle fractures: The (SMART-Ankle) feasibility study testing use of a weight bearing monitoring sensor post-surgery

Metro North Health Service0 个研究点目标入组 12 人开始时间: 2021年10月11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
12

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
Non-randomised trial
主要目的
Treatment

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • Are 18 years or older at the time of recruitment.
  • Have suffered an ankle fracture that can be classified as tibia/fibula, malleolar segment according to the AO Foundation-Orthopaedic Trauma Association (AO-OTA) Fracture and Dislocation Classification Compendium 2018
  • oinfrasyndesmotic fibula injury
  • otrans-syndesmotic fibula fracture, and
  • osupra-syndesmotic fibula injury
  • And, had ankle fracture surgery (fracture types include the fracture types described above and in addition single malleolar, bi-malleolar not extending into the tibial plafond and tri-malleolar with posterior fragment <20%).
  • Have a Charlson Comorbidity Index score of 4 or less.
  • Can stand and walk with and without crutches when wearing the Aircast boot at the time of data collection.
  • Can attend follow-up visits at the RBWH in person.

排除标准

  • 1.A Charlson Comorbidity Index score 5 or higher
  • 2.Foot or leg size incompatible with available Magnes shoes or Aircast boot
  • 3.Comorbidities:
  • a.concurrent or pre-existing injuries that impair the ability to use the orthosis as intended (e.g. neurological conditions including Multiple Sclerosis, brain injury, spinal cord injury);
  • b.patients with any other disorders involving restriction of mobility, limited ambulation on forearm crutches, or conditions affecting the fracture healing process (e.g. joint disease, neurological disorder, amputation)
  • c.BMI >35kg/m2
  • 4.Require non-standard postoperative care
  • 5.Not able to attend follow-up visits at the RBWH.
  • 6.Have suffered any of the following fracture types:
  • a.talus fractures
  • b.pilon (tibial plafond) fractures
  • c.calcaneal fractures
  • d.stress fractures
  • e.ankle fractures associated with ipsilateral (mid)foot fractures
  • f.bilateral lower limb fractures
  • g.concomitant upper limb fractures or injury
  • h.Posterior malleolus fractures requiring posterior plating
  • i.small and undisplaced fractures that can be managed non-operatively
  • j.trimalleolar fractures with significant posterior involvement that are not suitable for early weight-bearing
  • k.open (compound) fractures or fractures on both lower limbs.

研究者

发起方
Metro North Health Service

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