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临床试验/NCT02886221
NCT02886221已完成不适用

Functional and Radiographic Outcomes of Hallux Valgus Correction by Mini-invasive Surgery With Reverdin-Isham Percutaneous Osteotomy: a Longitudinal Prospective Study With a 48-month Follow-up

University of Padova2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2010年5月1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
250
试验地点
2
主要终点
clinical changes after surgical treatment

研究概览

简要总结

Minimally invasive surgery (MIS) represents one of the most innovative surgical treatments of Hallux Valgus (HV). However, long-term outcomes still remain a matter of discussion within the orthopaedic community. The purpose of this longitudinal prospective study was to evaluate radiographic and functional outcomes in patients with mild-to-severe HV who underwent Reverdin-Isham and Akin percutaneous osteotomy, following exostosectomy and lateral release.

详细描述

One hundred and eighty patients with mild-to-severe symptomatic HV were treated by MIS. Clinical evaluation was assessed pre-operatively, as well as at 3 and 12 months after surgery and at final follow-up of 48 months, using the American Orthopaedic Foot and Ankle Society (AOFAS) Hallux grading system. Patient satisfaction and complications were recorded.Further parameters assessed were postoperative pain at rest and during movement by the numerical rating scale (NRS), patient satisfaction using the Visual Analogue Scale (VAS), quality of life, and return to daily activities. Incidence of Chronic Pain Syndrome (CPS), Type of anesthesia and ASA were evaluated and recorded.

Computer-assisted measurement of antero-posterior radiographs was taken pre-operatively, as well as at 3 and 12 months after surgery and at 48-month follow-up, analysing the intermetatarsal angle (IMA), the hallux valgus angle (HVA), the distal metatarsal articular angle (DMAA), and the tibial sesamoid position. Also, the bridging bone/callus formation was evaluated at the different radiographic follow-ups, while the articular surface congruency and the metatarsal index were calculated only preoperatively and at last follow-up. Statistical analysis was carried out using the paired t-test. Statistical significance was set at p < 0.05.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Patients with mild to severe symptomatic hallux valgus

排除标准

  • congenital deformities of the foot
  • hallux rigidus
  • previous first ray trauma or foot and ankle surgery
  • rheumatic, dismetabolic, neurologic, infective, or psychiatric pathologies.

结局指标

主要结局

clinical changes after surgical treatment

时间窗: preoperative and at 3-12-48 months post-operative

evaluation scale: AOFAS score

次要结局

  • radiological changes after surgical treatment(preoperative and at 3-12-48 months post-operative)
  • Postoperative pain levels and incidence of Chronic Pain Syndrome (CPS)(Patients were evaluated prospectively at 7 days, 1, 3 and 6 months after surgery for pain at rest and during movement.)

研究者

发起方
University of Padova
申办方类型
Other
责任方
Principal Investigator
主要研究者

Carlo Biz

MD, Assistant Professor

University of Padova

研究点 (2)

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