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临床试验/NCT07553221
NCT07553221招募中不适用

Incidence and Management Implications of Talus Osteochondral Lesions in Tibial Plafond (Pilon) Fractures Identified Via Nano-Arthroscopy at Time of External Fixation: A Pilot Study

University of Missouri-Columbia2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2026年4月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
25
试验地点
2
主要终点
The total number of patients with talar osteochondral lesions in patients with tibial plafond fractures as determined by using images from the nano-arthroscopy at the time of external fixation

研究概览

简要总结

Patients with pilon fractures have a high incidence of talar osteochondral lesions. In this study, patients will undergo ankle arthroscopy at the time of external fixation. The objective is to help determine the incidence of these lesions with pilon fractures and to see if these nano-arthroscopy results change the plan for definitive treatment.

详细描述

Previous studies have demonstrated a high incidence of talus osteochondral lesions (OCLs) associated with rotational ankle fractures, with rates reported as high as 45%. Consequently, an increasing number of surgeons have employed ankle arthroscopy at the time of fixation to evaluate and manage potential OCLs.

To date, no studies have assessed the incidence of talus OCLs associated with high-energy tibial plafond (pilon) fractures. Ankle arthroscopy at the time of definitive fixation for pilon fractures is often contraindicated due to significant soft tissue swelling and the risk of wound complications. However, if concurrent OCLs could be identified at the time of temporizing external fixation using nano-arthroscopy, such findings could inform surgical planning, including modifications to approach, staging, or definitive management.

Patients will be identified through a treating relationship to the patient when they present for management of their injury. Written consent for the arthroscopy portion, photos, sample collection will be performed while they are in the hospital before surgery, or at the same time they are consented for surgery.

The goal of the study is to enroll 25 participants.

Study Procedures

研究设计

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

入排标准

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

入选标准

  • Age ≥ 18 years (skeletally mature) Tibial plafond fractures with impaction of the articular surface requiring external fixation for temporization AO/Orthopaedic Trauma Association (OTA) Fracture classification 43-C type fractures (excluding posterior pilon or supination-adduction type ankle fractures) Closed injury

排除标准

  • Prior ankle surgery
  • Pre-existing ankle arthritis
  • Unstable polytrauma patients precluding safe temporization
  • Concomitant talus or calcaneus fractures identifiable on plain radiographs
  • Unable to Consent

研究组 & 干预措施

Diagnostic Ankle Nano-Arthroscopy

Experimental

Following placement of the external fixator, the Arthrex Nanoscope will be introduced into the tibiotalar joint to evaluate for osteochondral lesions.

干预措施: Diagnostic Ankle Nano-Arthroscopy (Procedure)

结局指标

主要结局

The total number of patients with talar osteochondral lesions in patients with tibial plafond fractures as determined by using images from the nano-arthroscopy at the time of external fixation

时间窗: Perioperative

次要结局

  • The total number of patients that identification of osteochondral lesions (OCLs) influences surgical decision-making regarding timing, approach, or choice of definitive fixation technique by each surgeon.(Perioperative)

研究者

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

Brett D. Crist

PROFESSOR

University of Missouri-Columbia

研究点 (2)

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Talar Osteochondral Lesions With Pilon Fractures | 临床试验