跳至主要内容
临床试验/NCT04467099
NCT04467099Unknown不适用

Prevalence of Flexor Hallucis Longus Tears, Associated Os Trigonum Excision, and Return to Play

Forte Sports Medicine and Orthopedics2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年3月2日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
Incidence of flexor hallucis longus tears associated with os trigonum excision

研究概览

简要总结

The study's aim is to determine the incidence of flexor hallucis tendon tears associated with os trigonum excision. The study will then compare the length until functional return to play of the patients who had flexor hallucis tendon tears with concomitant os trigonum excision versus those without flexor hallucis tendon tears who underwent os trigonum excision. Lastly, the study will be evaluating the patient complaints and physical exam findings before and after surgery and compare those without flexor hallucis tendon tears to those with flexor hallucis tendon repair.

详细描述

Posterior ankle pain syndrome has many etiologies. Two main causes of this are flexor hallucis tendon tear and os trigonum impingement. The current teaching is that patients with flexor hallucis longus tear complain of posterior medial ankle pain and those with posterior lateral ankle pain have an os trigonum impingement. It is also classically understood that patients with flexor hallucis tendon tears take longer to return to their pre-injury level of function. Our clinical experience refutes these reports and our study looks to further evaluate it.

This study brings back patients who were treated by the study doctor. The patient's preoperative evaluation will be reviewed including clinic notes and imaging. The operative reports for these patients will be reviewed to verify the surgery procedure performed. These patients will be included in the study and we will utilize the American Academy of Orthopedic Surgeons Foot, Ankle, and Lower Limb module that they have completed postoperatively. This measure of patient's functional and subjective satisfaction has already been completed by patients at their regularly scheduled follow up appointments and is available for review.

Prospectively, patients will be asked to return to the clinic for a follow-up evaluation, which includes a standard x-ray. All patients will be consented prior to data collection, minors included in this study will be asked to sign an assent as well. Many factors will be assessed such as; a range of motion test of the ankle utilizing goniometric technique, nerve path and function, stability ankle grading, radiologic findings, and patient-reported outcomes filled out pre and postoperatively.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
11 Years 至 50 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Os trigonum excision with or without a flexor hallucis longus tear in an athletic population (recreational to competitive)
  • Males and females ages 11-50 at time of surgery

排除标准

  • Any other injury that will affect their return to play or recovery process
  • Individuals not actively involved in athletic sport/activity
  • Pregnant women
  • Any other concomitant injuries

结局指标

主要结局

Incidence of flexor hallucis longus tears associated with os trigonum excision

时间窗: Less than or equal to 30 days

How many participants had a tear.

次要结局

  • Patient responses to American Academy of Orthopaedic Surgeons (AAOS) Lower Limb questionnaire(preoperative; perioperative; intraoperative; Less than or equal to 30 days)
  • Change in foot and ankle areas of pain(preoperative; perioperative; intraoperative; Less than or equal to 30 days)
  • Change in foot and ankle nerve function(preoperative; perioperative; intraoperative; Less than or equal to 30 days)
  • Change in foot and ankle imaging for x-ray and magnetic resonance imaging(preoperative; perioperative; intraoperative; Less than or equal to 30 days)
  • Length until return to play(Less than or equal to 30 days)
  • Patient responses to American Academy of Orthopaedic Surgeons (AAOS) Foot and Ankle questionnaire(preoperative; perioperative; intraoperative; Less than or equal to 30 days)
  • Change in foot and ankle range of motion(preoperative; perioperative; intraoperative; Less than or equal to 30 days)
  • Change in foot and ankle stability(preoperative; perioperative; intraoperative; Less than or equal to 30 days)

研究者

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

David Porter

Orthopedic Surgeon

Forte Sports Medicine and Orthopedics

研究点 (2)

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