Bracing and Reconstruction of the Anterior Cruciate Ligament for Efficacy Trial

The ACL-Return to Sport after Injury scale (ACL-RSI) is a 12-item survey that measures psychological readiness to return to sport after an ACL injury or surgery. It uses a visual analog scale from 0 to 100, where higher scores indicate greater psychological readiness. The total score is calculated as a percentage of the 12-item total score.

A higher ACL-RSI score indicates a greater level of psychological readiness for returning to sport.

The TSK-11 (Tampa Scale for Kinesiophobia) is a 11-item questionnaire assessing fear of movement/re-injury, scored on a 4-point Likert scale (1-4) with a total score range of 11-44, where higher scores indicate greater fear of pain and movement.

Lower scores (closer to 11): Indicate minimal or no kinesiophobia (fear of movement/re-injury).

Higher scores (closer to 44): Suggest a greater degree of kinesiophobia.

The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms)

The Lysholm Knee Scoring Scale is a 100-point questionnaire used to assess knee function and is often used to evaluate knee injuries and surgeries, with higher scores indicating better function and fewer symptoms.

A higher score indicates better knee function and fewer symptoms. Scores are often categorized as excellent (95-100), good (84-94), fair (65-83), and poor (<65).

The Forgotten Joint Score (FJS-12) is a patient-reported outcome measure designed to assess how much a patient is aware of their artificial join in everyday life, with higher scores indicating less awareness and better surgical outcomes.

Each response is assigned a score (0-4), and the scores are summed and transformed to a 0-100 scale, with higher scores indicating less awareness of the joint.

Interpretation:

A higher score suggests that the patient is less aware of their joint, indicating a better outcome and higher satisfaction with the surgery.

The SANE score asks the patient to rate the shoulder on a scale from 0 to 100, with 100 being the patient's normal. Although singular in nature, the SANE score incorporates broad intangible differences in patient-perceived function, quality of life, and goals.

SANE scores range from 40% to 60% at baseline for most patients before treatment and range from 75% to 85% at 1 year after therapy depending on the condition

A 5-point Likert scale for surgery satisfaction typically uses a range from "Very Unsatisfied" to "Very Satisfied" with options like "Very Dissatisfied," "Dissatisfied," "Neutral," "Satisfied," and "Very Satisfied". This scale allows patients to express their level of satisfaction with various aspects of their surgical experience.

Very Dissatisfied/Very Unsatisfied (1): Indicates a very negative experience. Dissatisfied/Unsatisfied (2): Indicates a negative experience. Neutral (3): Indicates neither satisfaction nor dissatisfaction. Satisfied (4): Indicates a positive experience. Very Satisfied (5): Indicates a very positive experience.

a measurement tool used to gauge subjective experiences, especially pain, by having individuals mark a spot on a continuous line between two defined extremes, representing, for example, "no pain" and "worst pain".

A Lachmeter is a device that is attached above and below your knee, that will measure the laxity (looseness) of your knee.

The Lachman, pivot shift tests are all physical examination techniques used to assess the integrity of the anterior cruciate ligament (ACL) in the knee.

The Lachman anterior drawer tests are all physical examination techniques used to assess the integrity of the anterior cruciate ligament (ACL) in the knee.

The Tegner Activity Scale (TAS) is a simple, self-administered questionnaire that assesses a patient's level of activity, both at work and in sports, on a scale of 0 to 10The TAS is a 1-item questionnaire scored on a scale of 0 to 10.

0: represents maximum disability due to knee problems, such as being on sick leave or disability.

10: represents participation in competitive sports at a national or international elite level, like soccer.

Time to Return to Sport/Previous Activity Level

asked to reach a maximum distance in 3 different directions (shape of a "Y") - do this while standing on 1 leg and staying balanced. Both legs will be tested

asked to perform a maximum single leg broad jump - 2 reps on each leg

asked to perform a single leg triple hop (hop forward 3 times in a row) - 2 reps on each leg

measure the strength of your thigh muscles (quadriceps and hamstrings) - kick leg forward and pull leg backward as hard as possible - perform this assessment at 1 to 2 different speeds (the machine controls the speed). Both legs will be tested.

Reoperation Rate

Failure Rate

While wearing the brace, the sensor will track how many hours the brace is in use. The goal of the sensor is to track compliance of wearing the brace during rehabilitative and sport (or military) specific activity.

Number of Brace Complications