First Ray Kinematics Following Lapidus Bunion Surgery: A Fluoroscopic Gait Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Fluoroscopy Examination of the Foot.
研究概览
简要总结
This study is an observational "change from baseline" outcome measures design. Data is collected for the sake of evaluating treatment (fusion surgery) performed as standard medical care, but the investigator does not assign specific interventions to any participants in this study.
详细描述
Device/fluoroscopy measurements of arch motion and questionnaire data will be acquired on 10 women undergoing surgery for bunion, and 10 controls. Surgery will implant hardware to fuse (stabilize) the arch. Methods will evaluate the patient's problems associated with bunion and satisfaction with surgery, and assess the effectiveness of surgery in reducing motion of the arch. The hypotheses are that patients treated with surgery will demonstrate improvement in function, and that surgery will reduce motion of the arch postoperatively (posttest measures acquired 6 months after surgery), and in comparison to measures taken on a control group.
The data collected will come from a comprehensive examination. Methods will include the measurement of arch motion made by an examiner using a device and a fluoroscopic gait examination procedure, and completion of two medical questionnaires. The fluoroscopic acquisition of the digital images will be analyzed across the specified time dimensions of the gait cycle.
Device and fluoroscopy of measures of arch motion will be made at 2 time points on patients enrolled in this study: presurgery (baseline) and 6 months postsurgery. The questionnaire measurements of self-reported pain and function will be made at 4 time points: presurgery (baseline) and again at 3 months, 6 months, and 12 months postsurgery. Outcome measurements will be collected on control subjects at one time point only, on the day of their enrollment into the study.
Prospective studies have not characterized outcomes in patients receiving this type surgical fusion as part of the corrective treatment for bunion. Results have potential to improve surgical treatment outcomes and, improve upon the current methods of fluoroscopic motion analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18 or older.
- •Able to comprehend the risks associated with the study.
- •Able to complete the paperwork required for enrollment.
- •Able to walk without assistance of another individual.
排除标准
- •Pregnancy
- •History of great toe, forefoot or arch surgery, or severe traumatic injury.
- •Reduced ankle or great toe motion that impairs the ability to walk.
- •Observed evidence of foot deformity other than bunion.
- •Insensate to skin sensation testing which could indicate neuropathy.
结局指标
主要结局
Fluoroscopy Examination of the Foot.
时间窗: Change in Outcome Measurement [presurgery (baseline) and again 6 months postsurgery]
Fluoroscopic examination will image the foot during the roll-over phase of the gait. The participant will step in slow motion in front of the fluoroscopic x-ray beam to record the change in the position of the arch at specified gait-event time dimensions. Image acquisition will be at 25 frames per second lasting no longer than 2 seconds. All participants will wear leaded clothing in accordance with a protocol approved by the Univ of Minnesota Department of Health and Safety, Radiation Protection Division. Fluoroscopy "change in outcome measures" of arch motion will be made at 2 time points on all patients who participate: presurgery (baseline) and again 6 months postsurgery. Fluoroscopy measures will be acquired on control subjects at one time point only, on the day of their enrollment into the study.
次要结局
- Device Measurement of Arch Motion.(Change in Outcome Measurement. [presurgery (baseline) and again 6 months postsurgery])