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临床试验/NCT05793606
NCT05793606尚未招募不适用

The Effect of Deltoid Ligament Repair in Patients With Weber B Ankle Fracture; Randomized Controlled Trial.

Ministry of Health, Kuwait0 个研究点目标入组 100 人开始时间: 2023年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
Ankle instability measured with the Cumberland Ankle Instability Tool (CAIT)

研究概览

简要总结

Ankle injuries are common in musculoskeletal practice with high incidence rate in physically active individuals. Ankle injuries are complex to managed and further complicated with the high recurrence rate, chronic ankle instability, and osteoarthritis (Herzog et al., 2019). The prime ankle stabilizer against valgus forces is the deltoid ligament, which is a triangle band of strong connective tissues to prevent inward ankle rotation. The deltoid ligament is vital for maintaining ankle stability against valgus forces by its deep and superficial components as it restrains eversion and external rotation of the talus on the tibia (Lee et al., 2019). The superficial components of the deltoid ligament are the tibiospring, tibionavicular, tibiocalcaneal and superficial posterior tibiotalar ligaments, while the deep components are the anterior and posterior tibiotalar ligaments. The deep components of the deltoid ligament are the main stabilizers for the ankle joint, while the superficial components have minimal stabilization role (Michelsen et al., 1996; Pankovich, 2002; Jeong et al., 2014). Retraction of the deltoid ligament could cause medial ankle instability, pain, reduce function and early osteoarthritis (Lee et al., 2019). The deltoid ligament is essential for normal functioning of the foot and ankle and to maintain the normal kinematics of the talocrural kinematics. Dodd, Halai and Buckely (2022) discussed based on Ramsey and Hamilton's (1976) and Lubbeke et al..'s (2012) studies that a one mm lateral shift of the talus reduces the contact area of the tibiotalar up to 42%, and medial-sided injuries including an injury to the deltoid ligament would lead to long-term arthritis (Ramsey and Hamilton, 1976; Lubbeke et al., 2012; Dodd, Halai amd Buckley, 2022). More importantly, the deltoid ligament frequently raptures in association with ankle fractures (Wang et al., 2020). However, a recent systematic review stated that there is no consensus regarding deltoid ligament repair and its associated effectiveness and complications (Dodd, Halai and Buckely, 2022). Moreover, no study has explored the long-term effect of deltoid ligament repair in reducing post-traumatic ankle instability and osteoarthritis in patients with weber B fibula fractures. Therefore, the aim of the study is to determine the effect of deltoid ligament repair in patient with Weber B fibular fracture using randomized controlled trial design and two years follow-up period.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Female and male subjects.
  • Age 18-55 years.
  • Diagnosed with isolated weber B fibula facture with deltoid ligament injury confirm with radiography, MRI and CT scan. CT scan will be used to see the rotational element of the talus in the axial cuts and MRI to confirm the superficial ligament rupture.
  • Assigned for ORIF for the fibula.
  • One surgeon (MA) will perform the surgical intervention

排除标准

  • Patient with open fractures and syndesmotic injury
  • Previous ankle injury.
  • Multiple trauma of the lower extremities.
  • Rheumatoid arthritis or other chronic inflammatory condition.
  • Previous history of ankle instability
  • Ankle osteoarthritis
  • No osteochondral lesion

结局指标

主要结局

Ankle instability measured with the Cumberland Ankle Instability Tool (CAIT)

时间窗: two years

次要结局

  • • Foot and Ankle Ability Measure(two years)
  • • Global Rating of Function(two years)
  • • AOFAS(two years)
  • SF-12(two years)
  • VAS(two years)
  • • EQE5(two years)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Meshal Alhadhoud

Dr

Ministry of Health, Kuwait

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