Clinical trial NCT03700996: Clinical Outcome Following Arthroscopic Knee Surgery
Official title: Clinical Outcome Following Arthroscopic Knee Surgery (COFAKS)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anterior Cruciate Ligament Injury
Keywords: ACL
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Memorial Hermann Hospital
First posted: 2018-10-09
Enrollment: 2000
Sex: ALL
Minimum age (years): 10
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Exclusion Criteria:

* will be surgical candidates who have elected surgical intervention for internal derangement of the knee.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: International Knee Disability Committee (IKDC) Survey
timeFrame: Post op week 4
measure: International Knee Disability Committee (IKDC) Survey
timeFrame: Post op week 5
measure: International Knee Disability Committee (IKDC) Survey
timeFrame: Post op week 6
measure: International Knee Disability Committee (IKDC) Survey
timeFrame: Post op week 7
measure: International Knee Disability Committee (IKDC) Survey
timeFrame: Post op week 8
measure: International Knee Disability Committee (IKDC) Survey
timeFrame: Post op week 9
measure: International Knee Disability Committee (IKDC) Survey
timeFrame: Post op week 10
measure: International Knee Disability Committee (IKDC) Survey
timeFrame: Post op week 11
measure: International Knee Disability Committee (IKDC) Survey
timeFrame: Post op week 12
measure: International Knee Disability Committee (IKDC) Survey
timeFrame: Post op week 13
measure: International Knee Disability Committee (IKDC) Survey
timeFrame: Post op week 14
measure: International Knee Disability Committee (IKDC) Survey
timeFrame: Post op week 15
measure: International Knee Disability Committee (IKDC) Survey
timeFrame: Post op week 16
measure: International Knee Disability Committee (IKDC) Survey
timeFrame: Post op week 17
measure: International Knee Disability Committee (IKDC) Survey
timeFrame: Post op week 18
measure: International Knee Disability Committee (IKDC) Survey
timeFrame: Post op week 19
measure: International Knee Disability Committee (IKDC) Survey
timeFrame: Post op week 20
measure: International Knee Disability Committee (IKDC) Survey
timeFrame: Post op week Return to Sport: range 21 weeks to 52 weeks
measure: Marx Scale
timeFrame: Post op week 4
measure: Marx Scale
timeFrame: Post op week 5
measure: Marx Scale
timeFrame: Post op week 6
measure: Marx Scale
timeFrame: Post op week 7
measure: Marx Scale
timeFrame: Post op week 8
measure: Marx Scale
timeFrame: Post op week 9
measure: Marx Scale
timeFrame: Post op week 10
measure: Marx Scale
timeFrame: Post op week 11
measure: Marx Scale
timeFrame: Post op week 12
measure: Marx Scale
timeFrame: Post op week 13
measure: Marx Scale
timeFrame: Post op week 14
measure: Marx Scale
timeFrame: Post op week 15
measure: Marx Scale
timeFrame: Post op week 16
measure: Marx Scale
timeFrame: Post op week 17
measure: Marx Scale
timeFrame: Post op week 18
measure: Marx Scale
timeFrame: Post op week 19
measure: Marx Scale
timeFrame: Post op week 20
measure: Marx Scale
timeFrame: Post op week Return to Sport: range 21 weeks to 52 weeks
measure: Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
timeFrame: Post op week 4
measure: Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
timeFrame: Post op week 5
measure: Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
timeFrame: Post op week 6
measure: Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
timeFrame: Post op week 7
measure: Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
timeFrame: Post op week 8
measure: Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
timeFrame: Post op week 9
measure: Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
timeFrame: Post op week 10
measure: Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
timeFrame: Post op week 11
measure: Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
timeFrame: Post op week 12
measure: Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
timeFrame: Post op week 13
measure: Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
timeFrame: Post op week 14
measure: Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
timeFrame: Post op week 15
measure: Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
timeFrame: Post op week 16
measure: Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
timeFrame: Post op week 17
measure: Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
timeFrame: Post op week 18
measure: Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
timeFrame: Post op week 19
measure: Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
timeFrame: Post op week 20
measure: Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
timeFrame: Post op week Return to Sport: range 21 weeks to 52 weeks
measure: Range of Motion
timeFrame: Post op week 4
measure: Range of Motion
timeFrame: Post op week 5
measure: Range of Motion
timeFrame: Post op week 6
measure: Range of Motion
timeFrame: Post op week 7
measure: Range of Motion
timeFrame: Post op week 8
measure: Range of Motion
timeFrame: Post op week 9
measure: Range of Motion
timeFrame: Post op week 10
measure: Range of Motion
timeFrame: Post op week 11
measure: Range of Motion
timeFrame: Post op week 12
measure: Range of Motion
timeFrame: Post op week 13
measure: Range of Motion
timeFrame: Post op week 14
measure: Range of Motion
timeFrame: Post op week 15
measure: Range of Motion
timeFrame: Post op week 16
measure: Range of Motion
timeFrame: Post op week 17
measure: Range of Motion
timeFrame: Post op week 18
measure: Range of Motion
timeFrame: Post op week 19
measure: Range of Motion
timeFrame: Post op week 20
measure: Range of Motion
timeFrame: Post op week Return to Sport: range 21 weeks to 52 weeks
measure: Y-Balance
timeFrame: Post op week 8
measure: Y-Balance
timeFrame: Post op week 9
measure: Y-Balance
timeFrame: Post op week 10
measure: Y-Balance
timeFrame: Post op week 11
measure: Y-Balance
timeFrame: Post op week 12
measure: Y-Balance
timeFrame: Post op week 13
measure: Y-Balance
timeFrame: Post op week 14
measure: Y-Balance
timeFrame: Post op week 15
measure: Y-Balance
timeFrame: Post op week 16
measure: Y-Balance
timeFrame: Post op week 17
measure: Y-Balance
timeFrame: Post op week 18
measure: Y-Balance
timeFrame: Post op week 19
measure: Y-Balance
timeFrame: Post op week 20
measure: Y-Balance
timeFrame: Post op week Return to Sport: range 21 weeks to 52 weeks
measure: Single Leg Hop
timeFrame: Post op week 8
measure: Single Leg Hop
timeFrame: Post op week 9
measure: Single Leg Hop
timeFrame: Post op week 10
measure: Single Leg Hop
timeFrame: Post op week 11
measure: Single Leg Hop
timeFrame: Post op week 12
measure: Single Leg Hop
timeFrame: Post op week 13
measure: Single Leg Hop
timeFrame: Post op week 14
measure: Single Leg Hop
timeFrame: Post op week 15
measure: Single Leg Hop
timeFrame: Post op week 16
measure: Single Leg Hop
timeFrame: Post op week 17
measure: Single Leg Hop
timeFrame: Post op week 18
measure: Single Leg Hop
timeFrame: Post op week 19
measure: Single Leg Hop
timeFrame: Post op week 20
measure: Single Leg Hop
timeFrame: Post op week Return to Sport: range 21 weeks to 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center-Houston
state: Texas
Study officials:
affiliation: Memorial Hermann Hospital
name: Lane Bailey
role: PRINCIPAL_INVESTIGATOR
References: