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临床试验/NCT03356951
NCT03356951已完成不适用

Analysis of Patients Who Underwent Ankle Replacement and Simultaneous Subtalar Fusion by Biomechanical and Clinical Evaluation

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2017年3月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
23
试验地点
1
主要终点
Gait analysis

研究概览

简要总结

Subtalar fusion is commonly performed in post-traumatic subtalar osteoarthritis, rheumatoid arthritis, posterior tibial tendon dysfunction, tarsal coalition and primary subtalar osteoarthritis. Patients with osteoarthritis or severe dysfunction involving both the ankle and the subtalar joint may benefit from an tibiotalocalcaneal fusion (TTC) or an ankle replacement and subtalar fusion. With the development of new prosthetic designs and of surgical techniques, total ankle replacements (TAR) became a reasonable alternative to fusion with functional and quality of life improvements. A gait analysis of patients that underwent TAR and simultaneous subtalar fusion allows to study with precision and reliability the ankle range of motion (ROM). On the contrary, in healthy subjects or in patients that underwent isolated TAR this is not possible because the ankle ROM is influenced by the ROM of the subtalar joint in such a way that it is not possible to analyze the two joints separately. Also, excluding the role of the subtalar joint, it is possible to accurately analyze and compare the consequences on ankle kinematics of two different prosthetic designs.

详细描述

Patients who previously have underwent TAR and simultaneous subtalar fusion are retrospectively reviewed. Minimum follow-up after the surgery is 12 months.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who underwent ankle prosthesis (Hintegra ankle system, Zimmer Trabecular Metal Total Ankle) and simultaneous fusion of the subtalar joint with at least 12 months of follow-up willing and capable of adhering to postoperative clinical protocols and functional evaluations and who have signed a specific informed consent form approved by the Ethics Committee
  • Males or females aged between 20 and 80 years old.
  • Patients with diagnosis of primary not-inflammatory degenerative articular disease

排除标准

  • Patients with Body Mass Index (BMI)>
  • Patients with active or suspected latent periprosthetic infection
  • Patients who underwent revision surgery.
  • Prosthesis of the hip, knee or ankle, homolateral or contralateral.
  • Fusion failure of subtalar joint.
  • Patients with chronic heart failure (NYHA stage> 2)
  • Presence of neurological disorders, neuromuscular disorders or other major musculoskeletal pathologies
  • Cognitive deficits.
  • Impossibility to match questionnaires due to cognitive disorders or language dysfunctional disorders

结局指标

主要结局

Gait analysis

时间窗: 1 day

Differences in functional scores obtained by Mini-lab stereophotogrammetry-based Gait Analysis for Lower Limbs

次要结局

  • AOFAS(1 day)
  • Short Form Health Survey (SF-12)(1 day)
  • VAS (Visual Analog Scale)(1 day)

研究者

发起方
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
申办方类型
Other
责任方
Sponsor

研究点 (1)

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