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临床试验/NCT03700996
NCT03700996Unknown不适用

Clinical Outcome Following Arthroscopic Knee Surgery (COFAKS)

The University of Texas Health Science Center, Houston1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2014年10月23日最近更新:
适应症

试验速览

阶段
不适用
入组人数
2,000
试验地点
1
主要终点
International Knee Disability Committee (IKDC) Survey

研究概览

简要总结

Purpose: There are no existing data available to guide clinicians in the appropriate rehabilitation progression of patients who have undergone knee arthroscopy. The investigator intends to fill this void by establishing normative recovery curves for patients undergoing knee arthroscopy.

Research Design: Prospective Observational Design Procedures: Patients 10-70 years old will be screened for "standard of care" clinical and functional outcomes to occur at standardized time-points (post-op weeks 1-4, 8, 12, 16, 20 and return to sport/activity) following arthroscopic knee surgery. Recovery curves will be plotted for all outcome variables of interest including; (1) International knee Disability Committee (IKDC) survey, (2) Tampa Kinesiophobia scale, (3) Tegner activity scale, (4) Marx activity scale, (5) Passive knee range of motion/heel-height difference, (6) Balance Error Scoring System (BESS), (7) Quad/Hamstring strength ratios, (8) Y-Balance, (9) Functional Movement Screening, (10) Vail-Sport Test, (11) Landing Error Scoring System (LESS), (12) Hop Testing, and the (13) Sports Metrics Test. Polynomial lines-of-best-fit and 95% confidence intervals will be plotted to provide objective recovery curves for clinical utilization and stratification of patient recovery.

Risks: There are no additional risks to "standard physical therapy practice" for post-surgical patients participating in this study. The investigator will not be using invasive procedures or testing modalities that emit radiation.

Benefits & Clinical Relevance: This information may offer valuable information to clinicians treating patients following knee arthroscopy by providing objective data for each phase of post-operative recovery. Identifying key landmarks and functional milestones may allow the ability to identify patients who are not meeting clinical expectations and subsequently tailor rehabilitation programs to improve recovery trajectories.

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
10 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ages 10-70; undergoing primary knee arthroscopy; & participating in post-operative physical therapy management.

排除标准

  • Patients will be excluded from the study if they elect to not have knee arthroscopy. Have other orthopedic or medical complications (fractures, deep vein thrombosis,) that would be a contraindication to standard post-operative physical therapy care.

结局指标

主要结局

International Knee Disability Committee (IKDC) Survey

时间窗: Post op week Return to Sport: range 21 weeks to 52 weeks

Self-Report Outcomes: The International Knee Disability Committee Survey is an 18-item instrument designed to measure pain, symptoms, function and sports activity in patients with a variety of knee conditions. A sum score is calculated and then transformed to a 100-point scale, with 100 indicating no restrictions in daily and sports activities and the absence of symptoms. The overall score will be reported.

Marx Scale

时间窗: Post op week Return to Sport: range 21 weeks to 52 weeks

Self-Report Outcomes: MARX focuses on four activity points: running, deceleration, cutting (changes directions while running), and pivoting. The four knee functions are rated on a 5-point scale of frequency and scores added up to a maximum of 16 points with a higher score indicating more frequent participation.

Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)

时间窗: Post op week Return to Sport: range 21 weeks to 52 weeks

Self-Report Outcomes: Scale consists of 12 questions regarding the psychological impact of returning to sports in the sports population. The items are scored on a visual analogical scale from 0 to 100. With 100 being the better outcome. The overall score will be reported.

Range of Motion

时间窗: Post op week Return to Sport: range 21 weeks to 52 weeks

Clinical Measures: The normal movement of the knee measured in degrees from the center of the knee. The instrument used to take the measurement is called a double-armed goniometer.

Y-Balance

时间窗: Post op week Return to Sport: range 21 weeks to 52 weeks

Physical Performance

Single Leg Hop

时间窗: Post op week Return to Sport: range 21 weeks to 52 weeks

Physical Performance

次要结局

未报告次要终点

研究者

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

Lane Bailey

Director of Research and Education

The University of Texas Health Science Center, Houston

研究点 (1)

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