Recruiting

Observational Study

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT03700996

Conditions

Anterior Cruciate Ligament Injury

Eligibility Criteria

Sex: All

Age: 10 - 70

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Anterior Cruciate Ligament Injury

Study ID

NCT03700996

Start date

Oct 23, 2014

Status verified date

Sep, 2021

Completion date

Dec 23, 2021

Anticipated

Primary completion date

Dec 23, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • International Knee Disability Committee (IKDC) Survey [ Time Frame: Post op week 4 ]
  • International Knee Disability Committee (IKDC) Survey [ Time Frame: Post op week 5 ]
  • International Knee Disability Committee (IKDC) Survey [ Time Frame: Post op week 6 ]
  • International Knee Disability Committee (IKDC) Survey [ Time Frame: Post op week 7 ]
  • International Knee Disability Committee (IKDC) Survey [ Time Frame: Post op week 8 ]
  • International Knee Disability Committee (IKDC) Survey [ Time Frame: Post op week 9 ]
  • International Knee Disability Committee (IKDC) Survey [ Time Frame: Post op week 10 ]
  • International Knee Disability Committee (IKDC) Survey [ Time Frame: Post op week 11 ]
  • International Knee Disability Committee (IKDC) Survey [ Time Frame: Post op week 12 ]
  • International Knee Disability Committee (IKDC) Survey [ Time Frame: Post op week 13 ]
  • International Knee Disability Committee (IKDC) Survey [ Time Frame: Post op week 14 ]
  • International Knee Disability Committee (IKDC) Survey [ Time Frame: Post op week 15 ]
  • International Knee Disability Committee (IKDC) Survey [ Time Frame: Post op week 16 ]
  • International Knee Disability Committee (IKDC) Survey [ Time Frame: Post op week 17 ]
  • International Knee Disability Committee (IKDC) Survey [ Time Frame: Post op week 18 ]
  • International Knee Disability Committee (IKDC) Survey [ Time Frame: Post op week 19 ]
  • International Knee Disability Committee (IKDC) Survey [ Time Frame: Post op week 20 ]
  • International Knee Disability Committee (IKDC) Survey [ Time Frame: Post op week Return to Sport: range 21 weeks to 52 weeks ]
  • Marx Scale [ Time Frame: Post op week 4 ]
  • Marx Scale [ Time Frame: Post op week 5 ]
  • Marx Scale [ Time Frame: Post op week 6 ]
  • Marx Scale [ Time Frame: Post op week 7 ]
  • Marx Scale [ Time Frame: Post op week 8 ]
  • Marx Scale [ Time Frame: Post op week 9 ]
  • Marx Scale [ Time Frame: Post op week 10 ]
  • Marx Scale [ Time Frame: Post op week 11 ]
  • Marx Scale [ Time Frame: Post op week 12 ]
  • Marx Scale [ Time Frame: Post op week 13 ]
  • Marx Scale [ Time Frame: Post op week 14 ]
  • Marx Scale [ Time Frame: Post op week 15 ]
  • Marx Scale [ Time Frame: Post op week 16 ]
  • Marx Scale [ Time Frame: Post op week 17 ]
  • Marx Scale [ Time Frame: Post op week 18 ]
  • Marx Scale [ Time Frame: Post op week 19 ]
  • Marx Scale [ Time Frame: Post op week 20 ]
  • Marx Scale [ Time Frame: Post op week Return to Sport: range 21 weeks to 52 weeks ]
  • Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) [ Time Frame: Post op week 4 ]
  • Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) [ Time Frame: Post op week 5 ]
  • Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) [ Time Frame: Post op week 6 ]
  • Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) [ Time Frame: Post op week 7 ]
  • Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) [ Time Frame: Post op week 8 ]
  • Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) [ Time Frame: Post op week 9 ]
  • Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) [ Time Frame: Post op week 10 ]
  • Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) [ Time Frame: Post op week 11 ]
  • Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) [ Time Frame: Post op week 12 ]
  • Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) [ Time Frame: Post op week 13 ]
  • Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) [ Time Frame: Post op week 14 ]
  • Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) [ Time Frame: Post op week 15 ]
  • Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) [ Time Frame: Post op week 16 ]
  • Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) [ Time Frame: Post op week 17 ]
  • Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) [ Time Frame: Post op week 18 ]
  • Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) [ Time Frame: Post op week 19 ]
  • Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) [ Time Frame: Post op week 20 ]
  • Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) [ Time Frame: Post op week Return to Sport: range 21 weeks to 52 weeks ]
  • Range of Motion [ Time Frame: Post op week 4 ]
  • Range of Motion [ Time Frame: Post op week 5 ]
  • Range of Motion [ Time Frame: Post op week 6 ]
  • Range of Motion [ Time Frame: Post op week 7 ]
  • Range of Motion [ Time Frame: Post op week 8 ]
  • Range of Motion [ Time Frame: Post op week 9 ]
  • Range of Motion [ Time Frame: Post op week 10 ]
  • Range of Motion [ Time Frame: Post op week 11 ]
  • Range of Motion [ Time Frame: Post op week 12 ]
  • Range of Motion [ Time Frame: Post op week 13 ]
  • Range of Motion [ Time Frame: Post op week 14 ]
  • Range of Motion [ Time Frame: Post op week 15 ]
  • Range of Motion [ Time Frame: Post op week 16 ]
  • Range of Motion [ Time Frame: Post op week 17 ]
  • Range of Motion [ Time Frame: Post op week 18 ]
  • Range of Motion [ Time Frame: Post op week 19 ]
  • Range of Motion [ Time Frame: Post op week 20 ]
  • Range of Motion [ Time Frame: Post op week Return to Sport: range 21 weeks to 52 weeks ]
  • Y-Balance [ Time Frame: Post op week 8 ]
  • Y-Balance [ Time Frame: Post op week 9 ]
  • Y-Balance [ Time Frame: Post op week 10 ]
  • Y-Balance [ Time Frame: Post op week 11 ]
  • Y-Balance [ Time Frame: Post op week 12 ]
  • Y-Balance [ Time Frame: Post op week 13 ]
  • Y-Balance [ Time Frame: Post op week 14 ]
  • Y-Balance [ Time Frame: Post op week 15 ]
  • Y-Balance [ Time Frame: Post op week 16 ]
  • Y-Balance [ Time Frame: Post op week 17 ]
  • Y-Balance [ Time Frame: Post op week 18 ]
  • Y-Balance [ Time Frame: Post op week 19 ]
  • Y-Balance [ Time Frame: Post op week 20 ]
  • Y-Balance [ Time Frame: Post op week Return to Sport: range 21 weeks to 52 weeks ]
  • Single Leg Hop [ Time Frame: Post op week 8 ]
  • Single Leg Hop [ Time Frame: Post op week 9 ]
  • Single Leg Hop [ Time Frame: Post op week 10 ]
  • Single Leg Hop [ Time Frame: Post op week 11 ]
  • Single Leg Hop [ Time Frame: Post op week 12 ]
  • Single Leg Hop [ Time Frame: Post op week 13 ]
  • Single Leg Hop [ Time Frame: Post op week 14 ]
  • Single Leg Hop [ Time Frame: Post op week 15 ]
  • Single Leg Hop [ Time Frame: Post op week 16 ]
  • Single Leg Hop [ Time Frame: Post op week 17 ]
  • Single Leg Hop [ Time Frame: Post op week 18 ]
  • Single Leg Hop [ Time Frame: Post op week 19 ]
  • Single Leg Hop [ Time Frame: Post op week 20 ]
  • Single Leg Hop [ Time Frame: Post op week Return to Sport: range 21 weeks to 52 weeks ]

Central Contacts and Locations

Central contacts

Lane Bailey, PhD, PT

lane.bailey@memorialhermann.org

Locations

The University of Texas Health Science Center-Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Lane Bailey, PhD, PT

lane.bailey@uth.tmc.edu

Principal Investigator:

Lane Bailey, PhD, PT

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Sep 28, 2021

Last verified

Sep, 2021

Keywords

  • ACL

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2021-09-28.