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临床试验/NCT03272672
NCT03272672已完成不适用

Effects of a Valgus Unloader Brace on Medial Femoral Cartilage Changes Following Walking Protocol

University of North Carolina, Chapel Hill2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Pre walking - Thickness (mm) of the Medial Femoral Articular Cartilage as measured by ultrasound

研究概览

简要总结

The purpose of this study is to determine the effect of a valgus unloader brace condition on the acute change in medial femoral condyle cartilage morphology using Ultrasound following a standardized walking protocol.

详细描述

Participants will report to an initial screening session during which knee alignment will be determined using a long-lever goniometer. For the assessment of baseline knee alignment, the participant will stand with feet facing forward directly underneath corresponding acromion processes and weight evenly distributed. The first axis will be measured from ASIS to midpoint of the patella and the second axis will be measured from the midpoint of the patella to the tibial tuberosity. The valgus angle will be used to determine eligibility for the study. To be eligible for this study, participants must present with a valgus knee alignment angle of ≥180° on the dominant limb defined as the limb the participant would use to kick a ball. Weight and height measurements will also be measured and used to calculate BMI. Once eligible, participants will determine a self-selected walking speed by walking between 2 sets of infrared timing gates (TF100, TracTronix). Starting approximately 5 steps before the first timing gate, participants will be instructed to walk at a speed described as "comfortable walking over a sidewalk". Each participant will complete 3 trials and the average walking speed will be calculated.

Pre-loading Protocol

Participants will report to the laboratory at the same time of day (±2 hours) for both sessions to account for diurnal variations within the cartilage. Upon arrival, participants will sit on a treatment table in the long-sit position with knees fully extended for 45 mins to allow time for cartilage reformation.

Ultrasonographic Assessment of the Femoral Articular Cartilage While seated with their back up against the wall, participants will flex their knee to 140° measured using a manual goniometer while. A measuring tape will be secured to the length of the table so that the position of the posterior calcaneus can be recorded to allow for consistent positioning across trials 15. A LOGIQe US system (General Electric Co., Fairfield, CT) with a 12MHz linear probe will be used to image both the medial and lateral femoral cartilage. The probe will be placed transversely in line between the medial and lateral femoral condyles just superior to the patella and rotated to maximize reflection off the articular cartilage. A transparent grid will be placed over the US screen to improve reproducibility of the US image. The midpoint of the intercondylar groove will be aligned with the center of the grid.

The level of the cartilage-bone interface at the edge of the image on either side will be recorded in order to ensure consistent positioning across US assessments. Three images will be collected of each knee at each time point. Following each loading condition, the participant will be placed in the same position as the pre-loading US assessment using the tape measure. Three images of the femoral cartilage will be recorded from each knee. All post-walking images will be captured within 5 minutes of the loading protocol.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

盲法说明

A blinded investigator will segment all Ultrasound images.

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Uninjured participants. There will be no exclusion based on race, gender or ethnicity.

排除标准

  • congenital or degenerative joint condition, orthopedic implants, current joint pain (quantified as less than 2 on a 10cm visual analog scale),
  • cartilage injury of any joint, lower extremity fracture, or upper extremity fracture within the last year.
  • any major ligamentous or cartilage injury of the knee or hip joints, or reported of cartilage injury at the ankle.

结局指标

主要结局

Pre walking - Thickness (mm) of the Medial Femoral Articular Cartilage as measured by ultrasound

时间窗: Prior to the walking protocol

Thickness of the articular cartilage on the Medial Femoral condyle will be measured in millimeters

Post walking - Thickness (mm) of the Medial Femoral Articular Cartilage as measured by ultrasound

时间窗: Immediately following the walking protocol (the post-test will be finished within approximately 5 minutes of concluding the walking protocol)

Thickness of the articular cartilage on the Medial Femoral condyle will be measured in millimeters

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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