Clinical Outcome Following Arthroscopic Knee Surgery (COFAKS)
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
- 否
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
Lane Bailey
Director of Research and Education
The University of Texas Health Science Center, Houston
