Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Return to Work |
Subject self-assessment of time of return to pre-injury level. |
Subject is called every 2 weeks between 6-26 weeks post-op timepoint and asked when they returned to pre-injury level. |
|
| Secondary |
Visual Analog Scale (VAS) |
The VAS is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (0) and "worst pain (10). |
Data collected at the following time points: Pre-operative, 3 weeks, 6 weeks, 12 weeks, 26 weeks, 1 year, 2 years, 3 years, 4 years, 5 years |
|
| Secondary |
Veterans Rand (VR-12) |
The VR-12 is a patient-reported instrument from which physical and mental health component summary scores (Physical Component Score and Mental Component Score) are derived. The VR-12 items assess physical functioning, role limitations due to physical or mental health problems, pain, energy, mental health, social functioning, and general health. The United States population average PCS and MCS are both 50 points. The United States population standard deviation is 10 points. Therefore, each increment of 10 points above or below 50 corresponds to one standard deviation away from the population average. Change from pre-op and post-operative data collection timepoints will be assessed. |
Data collected at the following time points: Pre-operative, 6 weeks, 12 weeks, 26 weeks, 1 year, 2 years, 3 years, 4 years, 5 years |
|
| Secondary |
Foot and Ankle Ability Measure (FAAM) |
The FAAM is a self-report measure that assesses physical function of individuals with lower leg, foot, and ankle musculoskeletal disorders. The Foot and Ankle Ability Measure is a 29-item questionnaire divided into two subscales: the 21-item Activities of Daily Living Subscale and the 8-item Sports Subscale. Each item is scored on a 5-point Likert scale (4 to 0) from 'no difficulty at all' to 'unable to do'. Item score totals, which range from 0 to 84 for the ADL subscale and 0 to 32 for the Sports subscale, were transformed to percentage scores. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction. Change from pre-op and post-operative data collection timepoints will be assessed. |
Data collected at the following time points: Pre-operative, 6 weeks, 12 weeks, 26 weeks, 1 year, 2 years, 3 years, 4 years, 5 years |
|
| Secondary |
Karlsson and Peterson Scoring System |
TheKarlsson and Peterson Scoring System is a self-report that assesses ankle function. It is composed of 8 questions with a low score of 0 (low function) and a high score of 100 (high function). Change from pre-op and post-operative data collection timepoints will be assessed. |
Data collected at the following time points: Pre-operative, 6 weeks, 12 weeks, 26 weeks, 1 year, 2 years, 3 years, 4 years, 5 years |
|
| Secondary |
Tegner Activity Score |
The Tegner activity scale is a one-item score that grades activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer. Change from pre-op and post-operative data collection timepoints will be assessed. |
Data collected at the following time points: Pre-operative, 6 weeks, 12 weeks and 26 weeks. |
|
| Secondary |
Range Of Motion |
Range of motion of joints is measured using an instrument called a goniometer. Range of Motion will be measured using a goniometer during passive motion in a seated position. All measurements are from a neutral position. Normal values for the ankle are 0-50 degrees for plantar flexion and 0-20 degrees for dorsiflexion. For the foot, normal values are 0--35 degrees for inversion and 0-25 degrees for eversion. Change from pre-op and post-operative data collection timepoints will be assessed. |
Data collected at the following time points: Pre-operative, 6 weeks, 12 weeks, 26 weeks and 1 year. |
|
| Secondary |
Return to Sports |
Physician assessment of patient's return to sports. Yes or No response. |
Data collected at the following time points: 6 weeks, 12 weeks and 26 weeks |
|
| Secondary |
Stress X-ray |
A comparison of change in the anterior drawer and talar tilt. These findings determine the stability of the ligaments, The anterior drawer is measured in millimeters and the talar tilt is measured in degrees. |
Data will be collected at Pre-op and 1 year. |
|
