The Andrews Return to Sport ACL Score: A Developmental Study
Conditions: ACL Injury
Sponsor: Andrews Research & Education Foundation

Title: The Andrews Return to Sport ACL Score: A Developmental Study 
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Title:  
 
The Andrews Return to Sport ACL Score: A Developmental Study 
 
Principal Investigator:  
Adam Anz, M.D. 
 
Co-Investigators: 
 
James Andrews, M.D. 
 
 
 
 
Steve Jordan, M.D. 
 
 
 
 
Roger Ostrander, M.D. 
 
 
 
 
Tyler Opitz, DPT, SCS, CSCS 
Albi Gilmer, MSPT, OCS 
 
 
 
 
Ron Courson, ATC, PT, NRAEMT, CSCS 
 
 
 
 
Jessi Truett, MA, BCBA 
 
 
 
 
Joshua Cook, B.S. 
Chandler Bridges, M.S. 
 
 
 
 
Thomas Denney Jr., Ph.D. 
Funding Mechanism:  
Florida State Grant 
Institution:  
 
 
Andrews Institute 
                       
 
 1020 Gulf Breeze Pkwy. 
                         
 
Gulf Breeze, FL 32561 
                          
 
(850) 916- 8590 
 

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Table of Contents 
Abbreviations and Definitions 
4 
Background / Scientific Rationale 
5 
Objective: 
7 
Protocol Design 
7 
Hypotheses 
7 
Alternative Hypothesis: 
8 
Null Hypothesis: 
8 
Treatment Plan 
8 
Return To Sport Assessments: 
11 
Isokinetic Strength Testing: 
11 
Magnetic Resonance Imaging 
11 
Functional Movement Assessments: 
12 
Single Leg Squats: 
12 
Jump Analysis: 
13 
Single Leg Press: 
14 
Back Squat 
14 
Y Balance Test (YBT) 
14 
Patient Reported Outcomes 
15 
Tampa Kinesiophobia Scale: 
16 
Sports Participation Assessment: 
16 

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Reinjury Assessment: 
16 
International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC): 17 
Patient Reported Outcomes Measurements Information Systems (PROMIS) 
17 
Single Assessment Numeric Evaluation (SANE) 
17 
Review of Safety 
18 
Adverse Event (AE) 
18 
Serious Adverse Event (SAE) 
18 
Unanticipated Problem (UP): 
18 
AE & SAE Collection and Reporting 
19 
Risks and Discomforts 
20 
Safety Monitoring Plan 
20 
Quality Control and Assurance 
20 
Regulatory Requirements 
20 
21 CFR 50- informed consent: 
20 
Consent Withdrawal: 
21 
Participant Confidentiality 
21 
Data Analysis & Management Procedures 
22 
Data Collection 
22 
Statistical Analysis 
22 
References 
23 
Appendix 
25 

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Abbreviations and Definitions
ACL Anterior cruciate ligament 
AE    Adverse Event 
AREF Andrews Research and Education 
Foundation 
CRF  Case Report Form 
DHHS Department of Health and Human 
Services 
EDC  Electronic Data Capture 
FMS Functional Movement Screening 
GCP  Good Clinical Practice 
HIPAA Health Insurance Portability and 
Accountability Act 
H0            Null Hypothesis 
H1            Alternative Hypothesis 
IRB   Institutional Review Board 
JHFT Jump Height by Flight Time 
MRI 
Magnetic resonance imaging 
OKC Open Kinetic Chain 
PI      Principal Investigator 
PRO Patient Reported Outcomes 
RTP 
Return to Play 
RTS 
Return to Sport 
QA    Quality Assurance 
SAE  Severe Adverse Event 
SOC  Standard of Care 
SOP  Standard Operating Procedure 
TSK 
Tampa Scale for Kinesiophobia 
YBT Y Balance Test
 

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Background / Scientific Rationale 
It is estimated that 250,000 anterior cruciate ligament (ACL) injuries occur in the United States 
per year (Griffin et al., 2000, Gianotti et al., 2009). With ACL injuries being one of the most 
frequent injuries in both contact and noncontact sports, medical professionals need reliable tools 
to treat injured athletes and return them to sport in a safe/timely fashion (Harris et al., 2013). 
Along with the prevalence of initial injury, reinjury rates may be up to 30% in young active 
patients who undergo ACL surgical interventions. With the rate of return to competitive play 
post-ACL injury being 55%, it is imperative to create a systematic quantitative algorithm to 
safely return athletes to competitive play after ACL injury (Ardner et al.,2014). In addition to the 
primary injury often there is additional concern for instability of the knee, increased joint laxity, 
reduced activity and participation, as well as an increased risk of knee osteoarthritis in the future 
for the athlete (Lohmandeder et al., 2004). Along with the play time missed for the athletes, ACL 
injuries are associated with significant physical and mental harm as well as a lower health-related 
quality of life which supports the need for effective Return to Sport assessments.  However, the 
current literature is limited regarding the standardization and data-driven decision in regards to 
return-to-sport algorithms (Creighton et al., 2010).  Return-to-sport algorithms require further 
development. 
 Regenerative medicine technologies have the potential to expedite return to sport times after 
injury and surgery.  However,  to objectively study the application of regenerative medicine 
technologies to ACL injury and surgery, the development of an objective measurement system 
for the safe and appropriate return of patients to sport is required.  Ensuring patients are being 
safely returned to their sports after treatments for ACL injuries is important to decrease the risk 
of reinjury.  As noted in Grindem et al. (2016), athletes returning to sport with  asymmetrical 

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quadricep strength  have a significant risk increase for reinjury. After sustaining injury and 
operative intervention, a systematic evaluation process is needed to evaluate athletes’ progress 
towards returning to sport. To safely return to sport, an athlete must restore range of motion, 
strength, and stability and control across the affected and unaffected knee (Wilk et al., 2012; 
Bodor, 2001). With current advancements in technology, an up-to-date quantitative return to 
sport algorithm is presented. Multiple measures are required to capture the risk factors for 
reinjury such as imbalances and weaknesses that are not always evident in observation. The 
purpose of this study is to develop the Andrews ACL S.C.O.R.E (Subjective Clinical Outcome 
Return to Play Evaluation.) Development will begin with baseline measures and re-evaluation 
during the rehabilitation progression to address asymmetries and movement inefficiencies in a 
data driven manner with the ultimate goal of returning to play safely, without reinjury. A modern 
return to sport algorithm will include patient reported outcome measures, objective/modern 
strength and ability testing, and MRI evaluation of the reconstructed ACL tissue. Ardern et al. 
(2014) report the importance of assessing the psychological factors that impede athletes from 
returning to sport after ACL reconstruction. To address these individualized factors, patient 
reported outcomes are used to quantify these measures.  
A comprehensive assessment is required to ensure an athlete’s ability to safely return to sport is 
identified. This Return to Sport assessment must incorporate the overall health of the individual 
and assess specific measures of the affected ACL area. These qualities of assessment include the 
need for their strength to be at or near their preinjury level with symmetry to the non-injured leg, 
range of motion at or near their preinjury level with symmetry to the non-injured leg, joint 
stability at or near their preinjury level with symmetry to the non-injured level and confidence in 
movement comparable to the confidence in movement to the non-injured leg. As found by 

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Ardern et al. (2014) symmetry hopping in movement has positive predictive factors for returning 
to competitive sport levels after ACL reconstruction.  The functional movement screening 
assessment, a low-cost assessment, is also widely used to assess current functioning level. This 
assessment includes seven movement patterns to ensure the whole-body biomechanics can be 
assessed. The FMS assessment will provide a quantitative assessment of functional movement 
Objective: 
This project will develop a data driven decision making model to assess a competitive athlete’s 
readiness to return to sport after ACL injury and surgery safely. A specific audience and return to 
activity level specification is required for complete return to sport studies (Gokeler et al., 2017).  
This Return to Sport algorithm is targeting competitive pre-collegiate and collegiate athletes with 
a return to sport that is congruent with their pre-injury level of play.  
Return to Sport- Obtaining medical clearance to participate in competitive sports at the athlete’s 
pre-injury level 
Safely- Returning to pre-injury competitive level without instances of reinjury of the same ACL 
Protocol Design 
This will be a prospective cohort study of 100 competitive level pre-collegiate and collegiate 
level athletes who have sustained an ACL injury requiring reconstruction with a length of 
enrollment of 36 months.   
Hypotheses 

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Alternative Hypothesis: 
The prospective capture of multimodal data will improve the safe return of athletes to sport after 
ACL surgery and allow for the evaluation of regenerative medicine technologies to improve this 
process.  
 Patient reported outcomes and return to sport times will correlate directly with MRI objective 
scores and biometric strength/movement scores.  
Null Hypothesis: 
The prospective capture of multimodal data will not show improvement in the rate of safe return 
of athletes to sport after ACL surgery. 
 Patient reported outcomes and return to sport times will not directly correlate with MRI 
objective scores and biometric strength/movement scores.  
Treatment Plan 
For the one hundred participants recruited for this study, the duration of the treatment plan will 
be 24 months. Each of the participants will be qualified for the study due to falling within all 
inclusion criterion and no exclusion criterion. The screening of the inclusion criterion will occur 
at visit one of the study. At this time, the AREF Research Team will review and collect informed 
consent from each participant. Visit two will occur three (3) months after each participant’s ACL 
reconstruction surgery.  At this time, an evaluation by the treating physician will occur along 
with functional movement assessment and MRI. Visit three will occur six (6) months after each 
participant’s ACL reconstruction surgery.  At this time, an evaluation by the treating physician 

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will occur along with functional movement assessment and MRI. Visit four will occur nine (9) 
months after each participant’s ACL reconstruction surgery.  At this time, an evaluation by the 
treating physician will occur along with functional movement assessment and MRI. Visit five 
will occur twelve (12) months after each participant’s ACL reconstruction surgery.  At this time, 
an evaluation by the treating physician will occur along with functional movement assessment 
and MRI. Visit six will occur eighteen (18) months after each participant’s ACL reconstruction 
surgery.  At this time, an evaluation by the treating physician will occur along with functional 
movement assessment and MRI. Visit seven will occur twenty-four (24) months after each 
participant’s ACL reconstruction surgery.  At this time, an evaluation by the treating physician 
will occur along with functional movement assessment and MRI. At each time point, the treating 
physician or the therapist performing the functional movement assessment can choose to limit 
the functional movement assessment if there are concerns that the patient may not be ready for 
the expected load of one or more elements of the functional movement assessment.  
At each monthly time point after ACL reconstruction patient reported outcomes will be collected 
by the research team to assist in assessing the overall health and confidence in Return to Sport 
for each athlete. The following patient reported outcomes will be collected in written or 
electronic format after informed consent has been obtained from each participant:  Sports 
Participation, Reinjury, Tampa Kinesiophobia Scale, IKDC, PROMIS, SANE. 
Participation: 
A total of 100 competitive pre-collegiate or collegiate athletes will be recruited for participation 
in the Andrews Return to Sport algorithm study. Participants in the study will be individuals who 
have provided informed consent to the research team to adhere to the provided research protocol.  

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Inclusion Criterion: 
One hundred (100) pre-collegiate or collegiate level athletes will be included in this study. They 
will fall within the following inclusion criterion: 
1. Age 14-24 years 
2. Require ACL reconstruction surgery 
3. No other ligament injury which would require repair or reconstruction to lower extremity 
is present as assessed by treating physician 
4. Exhibits desire to return to pre-injury competitive level 
5. Assessed to be in good physical health condition by the treating physician 
Exclusion Criterion:  
1. Requires more than one ACL reconstruction surgery at time of screening 
2. Has comorbid lower extremity diagnoses which would impede return to sport as assessed 
by the treating physician 
3. Does not desire to return to pre-injury competitive sport level 
Benefits: 
Each study participant will be provided with a total five hundred dollars ($500.00) for their 
participation in the study through the 24-month period. The $500.00 will be dispersed on the 
following predetermined schedule.  $100.00 at Visit 2, $100.00 at Visit 3, $100.00 at Visit 5,  
$100.00 at Visit 6,  and $100.00 at Visit 7. If a participant withdraws from the study the 

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monetary benefits will not be dispersed after the withdrawal date. However, there will be no 
effect on the medical care provided if a participant withdraws from the study. 
Return To Sport Assessments: 
Isokinetic Strength Testing: 
Isokinetic strength testing is crucial to assess the muscular strength of the quadricep and 
hamstring after ACL reconstruction. Due to the high rate of reinjury with known predictive 
factors due to imbalance in strength, a quantitative measure of balance of strength is required to 
guide return to sport decision making. An isokinetic dynamometer will be used to assess knee 
extensor and flexor strength (Riesterer et al., 2020). Isokinetic strength testing will support the 
Andrews Return to Sport algorithm through multimodal functional assessments.  
Magnetic Resonance Imaging 
Magnetic Resonance Imaging (MRI) will be used as a noninvasive assessment tool to obtain 
quantitative measures to assess progress in graft maturity and rehabilitation towards safe return 
to sport. As the injured ACL undergoes ligamentization, MRI will be used to monitor the 
progress of each participant through T2* analysis and volume at the following time intervals:  
3months, 6months, 9months, 12months, 18months, and 24months. MRIs will review the 
integrity of each graft, placement within the tunnel, and tunnel healing, and healing of the donor 
site (Grassi et al., 2016). 

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Functional Movement Assessments:  
The functional movement screening assessment (FMS) is widely used to assess current 
functioning level and does not require significant monetary resources to provide this assessment. 
This assessment includes seven movement patterns to ensure the whole-body biomechanics can 
be assessed. The movements required are deep squat, hurdle step, inline lunge, shoulder 
mobility, active straight leg raise, trunk stability push up, and rotary stability assessment. FMS 
screening will be used to identify the precursor deficits which could lead to reinjury. These 
deficits include increased anterior tibial shear force, decrease knee flexion, decreased hip flexion, 
increased knee internal rotation, increased trunk flexion, and increased lumbar hyperextension. 
The FMS assessment will provide a quantitative assessment of functional movement on a 0-3 
scale as follows (Hoogenboom, Voight, Cook, & Rose, 2013). 
3- Individual can perform the movement without any compensation. 
2- Individual can perform the movement but must utilize poor mechanics and compensatory 
patterns to accomplish the movement. 
1- One is given if the individual cannot perform the movement pattern even with compensation. 
0- Individual reports pain during activity. 
Single Leg Squats:   
The single leg squat assessment is commonly used to evaluate the eccentric and concentric 
contractions of the muscles in the upper leg, lower leg, and hip (Bailey et al., 2010). This test 
was first executed and defined the method for performing by Livengood (2004) to assess 
balance, strength, and the kinetic chain. To rate the single leg squat test, Livengood also assigned 

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a scale to the test (Figure 1). Each participant will be instructed to squat down to approximately 
60 degrees with a time constraint of six seconds while holding one leg suspended in the air. 
When analyzing the movements within the single leg squat, researchers assess the functioning 
and symmetry of following muscles and the activity associated: vastus medialis obliquus, gluteus 
medius, hip flexion, hip abduction, and knee flexion (Table 1). 
Jump Analysis: 
The jump analysis highlights the importance of the monthly psychological data review 
completed by the Kinesiophobia Scale. In review of this data, the psychological apprehension 
will guide the functional jump analysis.  The jump analysis will occur initially from both legs to 
address psychological apprehension (Davies et al., 2017). From this assessment, calculation is 
made based on the allometric scaling to each participant’s height (Davies et al., 2017). 
Additionally, flight time will be measured as defined by the time (s) when the participant’s feet 
leave the platform and subsequently contact the platform again (Jordan et al., 2020). 
Additionally, the jump height by flight time (JHFT) will be measured. JHFT is defined as the 
distance the marker on the malleolus moved from lowest point when in contact with the platform 
to the highest point during the jump.  
A single leg hop assessment will also be performed across both the injured and non-injured legs. 
The score for this assessment is the distance travelled from the start to the location of the 
posterior heel of the landing leg (Manske & Reiman, 2013). The variability of scores across the 
injured and non-injured leg will be used as a measure of symmetry in function movement for 
each athlete. 

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Additionally, a double leg hop will be scored during the jump analysis. The score for this 
assessment is the distance travelled from the start to the location of the posterior heel of the 
landing leg (Manske & Reiman, 2013). Additionally the participant’s jump will be assessment 
for symmetry in takeoff and landing across both the injured and uninjured leg.  
Single Leg Press: 
Additional readiness measures will be assessed through the single leg press motion. As the 
participants progress in rehabilitation a body weight single leg press will be completed across 
both the injured and non-injured leg until failure. Then a single leg press with 25% body weight 
will be completed until failure. This measure of repetitions until failure will be used to assess the 
current fatigue level of the injured leg regarding readiness to Return to Sport. This measure will 
also occur quantitative data as a measure of deficit which will align with future reinjury rates.  
Back Squat  
Each participant will undergo a back squat assessment as they progress in rehabilitation. Once 
the investigator deems the participant stable in the descending, stable hold position, and 
ascending motion. Each participant’s movement pattern while completing a back squat will be 
assessed for stability and strength in maintaining position.  
Y Balance Test (YBT) 
The Y Balance Test is a reliable, yet simple assessment to measure the participant's strength, 
stability, balance, and confidence while moving in three different directions. The YBT requires 
the participant to balance on one leg at a time and to reach as far as possible with the suspended 
leg in three separate directions, anterior, posterolateral, and posteromedial. This assessment will 

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measure the level of rehabilitation by measuring the knee flexor and hip adductor strength after 
ACL injury (Walker, 2016).  
The test will follow the procedural order of: 
1. Right Anterior 
2. Left Anterior 
3. Right Posteromedial 
4. Left Posteromedial 
5. Right Posterolateral 
6. Left Posterolateral 
At the completion of the above sequence the following calculations will occur: 
Absolute Reach Distance (cm)= (Reach 1 + Reach 2 + Reach 3)/3 
Relative Reach Distance (%) = Absolute Reach Distance/Limb Length X 100 
Composite Reach Distance (%) = Sum of the 3 Reach Directions/3 Times the Limb Length X 
100 
Patient Reported Outcomes 
Monthly assessments of each participant’s patient reported outcomes will be used to quantify 
physical and psychological aspects of rehabilitation after ACL reconstruction monthly after 
informed consent has been obtained and surgery has occurred.  

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Tampa Kinesiophobia Scale: 
The fear of reinjury can be a barrier to the rehabilitation of competitive athletes after 
ACL reconstruction. To operationalize the fear associated with reinjury the Tampa 
Kinesiophobia (TSK) will be provided monthly to participants in the study to complete 
(Lundberg et al., 2009). Kinesiophobia is defined as the fear of movement (Lundberg et 
al., 2009). This measure will be collected to evaluate progression in rehabilitation to take 
into account not only the physical health of the injured athlete but also the psychological 
effects and rehabilitation. 
 
Sports Participation Assessment:  
A sports participation assessment will be completed monthly by the participants of the 
research project to quantify the participant’s participation in sports activity during the 
rehabilitation period. 
 
Reinjury Assessment: 
A monthly injury questionnaire will be provided to each participant of the study to assess 
the rate of reinjury during the rehabilitation process. If reinjury is noted in the monthly 
questionnaire, the AREF research team will alert the principal investigator to ensure 
continuity of care is provided.  

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International Knee Documentation Committee Subjective Knee Evaluation Form 
(IKDC): 
The International Knee Documentation Committee Subjective Knee Evaluation (IKDC) 
form will contribute to the comprehensive data set to evaluate each participant’s 
confidence in performance on a monthly schedule. IKDC has 19 questions that will take 
approximately 3-5 minutes for each participant to complete monthly. IKDC data will be 
collected by the AREF research team and reviewed with the primary investigator. 
Patient Reported Outcomes Measurements Information Systems (PROMIS) 
The patient reported outcomes measurement information system (PROMIS) is a 
measurement system used monthly in this project to assess monthly the overall health 
functioning and rehabilitation levels of each participant (Brodke, Saltzman, & Brodke, 
2016). AREF will collect this data and alert the primary investigator if any adverse 
outcomes are found. The addition of the PROMIS data is required to ensure that a 
comprehensive assessment of overall functioning is reviewed in the determination of 
athlete readiness to return to sport.  
 
Single Assessment Numeric Evaluation (SANE) 
The SANE assessment is a single question patient reported outcome from a rating of 0-
100 for each participant to score their current functioning in comparison to their pre-
injury functioning level (O’Connor & Ring, 2019).  This assessment will be collected 
monthly after ACL reconstruction by the AREF research team for each participant.  

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Review of Safety 
Adverse Event (AE) 
An adverse event is any untoward or unfavorable medical occurrence in the human subject, 
including any abnormal sign, symptom, or disease, temporally associated with the subject’s 
participation in the research, whether considered related to the subject’s participation in the 
research or not considered related to the subject’s participation in the research. 
Serious Adverse Event (SAE) 
Serious adheres events are any events that: 
● Result in death 
● Is life threatening, or places the participant at immediate risk of death from the event as it 
occurred 
● Requires or prolongs hospitalization 
● Causes persistent or significant disability or incapacity 
● Results in congenital anomalies or birth defects 
● Is another condition which investigators just to represent significant hazards 
Unanticipated Problem (UP): 
Defined by DHHS 45 CFR part 46 as any incident, experience, or outcome that meets the 
following criteria. 

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● unexpected, in terms of nature, severity, or frequency, given (a) the research procedures 
that are described in the protocol-related documents, such as the IRB-approved research 
protocol and informed consent document; and (b) the characteristics of the study 
population. 
● related or possibly related to participation in the research (in this guidance document, 
possibly related means there is a reasonable possibility that the incident, experience, or 
outcome may have been caused by the procedures involved in the research); 
● suggests that the research places participants or others at a greater risk of harm (including 
physical, psychological, economic, or social harm) than was previously known or 
recognized. 
AE & SAE Collection and Reporting 
Throughout the study the research team will monitor the occurrence of AE and SAE. Data will 
be collected if an instance occurs, and the PI will be notified. All AE data, such as onset date, 
resolution date, outcome and treatments given will be documented in the source documents and 
will be recorded in the EDC and analyzed for severity to follow reporting protocol if severity 
level. 
Follow-up will occur using the provided safety monitoring form if AE occurs. The follow up will 
end either when the symptoms resolve or up to 30 days past the end of the study participation. 

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Risks and Discomforts 
As with any research involving participants, there is the inherent risk of a breach in patient 
confidentiality though this will be minimized using participant code numbers and adherence to 
all HIPAA guidelines.  
Safety Monitoring Plan 
The safety of each participant will be monitored through multiple channels as the primary focus 
on this project is to ensure the safe return to sport for each participant. Along with the medical 
evaluation performed at each of the seven study visits. Monthly patient reported outcomes will 
be collected and reviewed to ensure no additional injury or premature return to sport has 
occurred. Any deviation from protocol recommendations will be reported by the AREF research 
team to the principal investigator to assess and rectify participant actions if needed.  
Quality Control and Assurance 
All protocols will be monitored and analyzed data will be checked for accuracy by the principal 
investigator and /or a designated AREF research team member. All medical data will be kept in 
compliance with HIPAA guidelines. 
Regulatory Requirements 
21 CFR 50- informed consent: 
In adherence to the 21 CFR 50, Protection of Human Subjects Guidelines, the informed consent 
process will be performed by one of the study investigators or staff, in the research office on 

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paper or electronically via REDCap. REDCap is a secure web application for building and 
managing online surveys and databases. While REDCap can be used to collect virtually any type 
of data in any environment (including compliance with 21 CFR Part 11, FISMA, HIPAA, and 
GDPR), it is specifically geared to support online and offline data capture for research studies 
and operations. The REDCap Consortium, a vast support network of collaborators, is composed 
of thousands of active institutional partners in over one hundred countries who utilize and 
support their own individual REDCap systems. All participants will have the study described to 
them and will be given as much time as they require to read an approved, IRB stamped version 
of the informed consent document. The designee will review with each participant that they are 
free to refuse to participate in the study or to withdraw from it at any time. 
After physical or electronic signing of the informed consent document, participants will be given 
a copy for their records. No aspects of the study will be conducted prior to obtaining informed 
consent from each participant. 
Consent Withdrawal: 
During the informed consent process, participants will be informed that if at any point during the 
study, consent may be withdrawn. To withdraw consent, participants can request in writing to 
withdraw HIPAA authorization and the research site will not use or provide any health 
information to researchers. At this time, the link between the participant’s health information 
will be severed with the research team. This process for consent withdrawal will be reviewed 
with each participant and identified barriers will be addressed at the time of informed consent.  
Participant Confidentiality 

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Signed consent forms for each subject will be de-identified by a coding system with the subject’s 
unique study identification system.  Authorization to use each subject’s personal health 
information will be obtained during the informed consent procedure to adhere to the federal 
Health Insurance Portability and Accountability Act (HIPAA). The consent will specifically 
grant permission to use health information obtained as part of the presented study. 
Data Analysis & Management Procedures 
This study is anticipated to take 2 years to complete after informed consent is obtained for each 
participant. All data will be entered into REDCap. The investigators will meet at appropriate 
intervals to evaluate and analyze the data.  
Data Collection 
Data will be collected using the Electronic Data Capture (EDC) system. Reports of data will be 
used by internal site monitors to ensure accuracy of data elements. Data will be kept secure to 
reduce chances of breach of confidentiality. Data will also be de-identified as another 
confidentiality best practice measure. 
Statistical Analysis 
All patient data will be entered into EDC. The investigators will meet at appropriate intervals to 
evaluate and analyze the data. All compiled data will be de-identified. 
 
 

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Appendix 
Treatment Schedule:  
1.     Visit 1- Screening Visit (Informed Consent/Review Inclusion and Exclusion) 
2.     Visit 2- (3 mo after ACL Reconstruction)-  $100.00 to participant 
a.     Strength/Functional Testing with a Therapist, MRI 
3.     Visit 3- (6 mo after ACL Reconstruction)-  $100.00 to participant 
a.     Strength/Functional Testing with a Therapist, MRI 
4.     Visit 4- (9 mo after ACL Reconstruction)-  
a.     Strength/Functional Testing with a Therapist, MRI 
5.     Visit 5- (12 mo after ACL Reconstruction)- $100.00 to participant 
a.     Strength/Functional Testing with a Therapist, MRI 
6.     Visit 6- (18 mo after ACL Reconstruction)-  $100.00 to participant 
a.    Strength/Functional Testing with a Therapist, MRI 
7.     Visit 7- (24 mo after ACL Reconstruction)- $100.00 to participant 
a.     Strength/Functional Testing with a Therapist, MRI 
PRO: Monthly 
1. Sports Participation (Monthly) 

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2. Reinjury (Monthly) 
3. Tampa Kinesiophobia Scale (Monthly) 
4. IKDC (Monthly) 
5. PROMIS (Monthly) 
6. SANE (Monthly) 
MRI: 3mo, 6mo, 9mo, 12mo, 18mo, 24mo 
1. Volume 
2. Mean T2* Values 
Strength/Functional Testing with a Therapist: 3mo, 6mo, 9mo, 12mo, 18mo, 24mo 
1. Isokinetic Strength Testing 
2. FMS- Functional Movement Screening 
3. Y-Balance 
4. Single Leg Hop 
5. Single Leg Press with Body weight (number of reps), 25% body weight (number of reps) 
 
 
 
 
 

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Tampa Scale for Kinesiophobia 
(Miller, Kori and Todd 1991) 
1 = strongly disagree 
2 = disagree 
3 = agree 
4 = strongly agree 
1. I’m afraid that I might injury myself if I exercise 
1 
2 
3 
4 
2. If I were to try to overcome it, my pain would increase 
1 
2 
3 
4 
3. My body is telling me I have something dangerously 
wrong 
1 
2 
3 
4 
4. My pain would probably be relieved if I were to 
exercise 
1 
2 
3 
4 
5. People aren’t taking my medical condition seriously 
enough 
1 
2 
3 
4 
6. My accident has put my body at risk for the rest of 
my life 
1 
2 
3 
4 
7. Pain always means I have injured my body 
1 
2 
3 
4 
8. Just because something aggravates my pain does not 
mean it is dangerous 
1 
2 
3 
4 

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9. I am afraid that I might injure myself accidentally 
1 
2 
3 
4 
10. Simply being careful that I do not make any 
unnecessary movements is the safest thing I can do to 
prevent my pain from worsening 
1 
2 
3 
4 
11. I wouldn’t have this much pain if there weren’t 
something potentially dangerous going on in my body 
1 
2 
3 
4 
12. Although my condition is painful, I would be 
better off if I were physically active 
1 
2 
3 
4 
13. Pain lets me know when to stop exercising so 
that I don’t injure myself 
1 
2 
3 
4 
14. It’s really not safe for a person with a condition like 
mine to be physically active 
1 
2 
3 
4 
15. I can’t do all the things normal people do 
because it’s too easy for me to get injured 
1 
2 
3 
4 
16. Even though something is causing me a lot of 
pain, I don’t think it’s actually dangerous 
1 
2 
3 
4 
17. No one should have to exercise when he/she is in 
pain 
1 
2 
3 
4 
Scoring Information Tampa Scale for Kinesiophobia (Miller et al., 1991) 
A total score is calculated after inversion of the individual scores of items 4, 8, 12 and 16. 
 

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2000 IKDC SUBJECTIVE KNEE EVALUATION FORM 
Name:  
 
 
 
 
Date:  
 
 
 
Physician:                               
Date of Injury: 
SYMPTOMS*: 
*Grade symptoms at the highest activity level at which you think you could 
function without significant symptoms, even if you are not actually performing 
activities at this level. 
1. What is the highest level of activity that you can perform without significant knee pain? 
Very strenuous activities like jumping or pivoting as in basketball or soccer 
Strenuous activities like heavy physical work, skiing or tennis 
Moderate activities like moderate physical work, running or jogging 
Light activities like walking, housework, or yard work 
Unable to perform any of the above activities due to giving way of the knee 
2. During the past 4 weeks, or since your injury, how often have you had pain?  
0         1         2         3         4         5         6         7         8          9         10 
Never        
                                                                                              Constant 
3. If you have pain, how severe is it? 
0         1         2         3         4         5         6         7         8         9   
10 
No pain  
                                                                                Worse pain imaginable 
4. During the past 4 weeks, or since your injury, how stiff or swollen was your knee 

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Not at all 
Mildly 
Moderately 
Very 
Extremely 
5. What is the highest level of activity you can perform without significant swelling in your 
knee? 
Very strenuous activities like jumping or pivoting as in basketball or soccer 
Strenuous activities like heavy physical work, skiing or tennis 
Moderate activities like moderate physical work, running or jogging 
Light activities like walking, housework, or yard work 
Unable to perform any of the above activities due to giving way of the knee 
6. During the past 4 weeks, or since your injury, did your knee lock or catch? 
 Yes        
  No 
7. What is the highest level of activity you can perform without significant giving way in your 
knee? 
Very strenuous activities like jumping or pivoting as in basketball or soccer 
Strenuous activities like heavy physical work, skiing or tennis 
Moderate activities like moderate physical work, running or jogging 
Light activities like walking, housework, or yard work 
Unable to perform any of the above activities due to giving way of the knee 
SPORTS ACTIVITIES: 
8. What is the highest level of activity you can participate in on a regular basis? 

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Very strenuous activities like jumping or pivoting as in basketball or soccer 
Strenuous activities like heavy physical work, skiing or tennis 
Moderate activities like moderate physical work, running or jogging 
Light activities like walking, housework, or yard work 
Unable to perform any of the above activities due to giving way of the knee 
9. How does your knee affect your ability to: 
  
  
Not 
difficult 
at all 
Minimall
y 
difficult 
Moderate
ly 
Difficult 
Extremel
y 
difficult 
Unable 
to do 
A. 
Go up stairs 
 
 
 
 
 
 
 
 
 
 
B. 
Go down stairs 
 
 
 
 
 
 
 
 
 
 
C. 
Kneel on the front of 
your knee 
 
 
 
 
 
 
 
 
 
 
D. 
Squat 
 
 
 
 
 
 
  
 
 
E. 
Sit with your knee 
bent 
 
 
 
 
 
 
 
 
 
 
F. 
Rise from a chair 
 
 
 
 
 
 
 
 
 
 
G. 
Run straight ahead 
 
 
 
 
 
 
 
 
 
 

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H. 
Jump and land on your 
involved leg 
 
 
 
 
 
 
 
 
 
 
I. 
Stop and start quickly 
 
 
 
 
 
 
 
 
 
 
FUNCTION: 
10.   How would you rate the function of your knee on a scale of 0 to 10 with 10 being 
normal, excellent function and 0 being the inability to perform any of your usual daily 
activities which may include sports? 
FUNCTION PRIOR TO YOUR KNEE INJURY: 
0         1         2         3         4         5         6         7         8         9           
10 
Couldn't perform daily 
activities 
 
 
 
 
 
 
 
 
 
 
 
 
 
               No limitations in daily activities 
CURRENT FUNCTION OF YOUR KNEE: 
0         
1         2         3         4         5         6         7         8         9           
10 
Cannot perform daily 
activities 
 
 
 
 
 
 
 
 
 
 
 
 
                      No limitation in daily activities 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Single Leg Squat Scoring 
 
Figure 1.  Single leg squat - Scoring Criteria for movements of closed chain limb 
Single Leg Squat Assessment 
Left 
Right 
Foot 
Foot Flattens 
yes/no 
yes/no 
Knee 
Positioning/Valgus 
Moves Inward 
Moves Outward 
Moves Inward 
Moves Outward 
Pelvic Plane 
Excessive Tilt (Ant/Post) 
yes/no 
yes/no 
Stance/Stability 
Stability: Noticeable instability  
yes/no 
yes/no 
Pain 
Verbal report of pain 
yes/no 
yes/no 
Table 1. Single leg squat assessment