Platelet-Rich Plasma (PRP) Therapy for Patellar Tendinopathy: A Randomized Controlled Trial Correlating Clinical, Biomechanical and Novel Imaging Biomarkers
Phase: PHASE2
Conditions: Patellar Tendinitis
Sponsor: University of Wisconsin, Madison

 
 
 
[Year] 
Platelet-Rich Plasma Therapy for Patellar 
Tendinopathy: A Randomized Controlled Trial 
Correlating Clinical, Biomechanical and Novel 
Imaging Biomarkers 
NCT03136965 
12/23/2021 

1 
 
 Platelet-Rich Plasma Therapy for Patellar Tendinopathy: A 
Randomized Controlled Trial Correlating Clinical, 
Biomechanical and Novel Imaging Biomarkers 
 
 
UW IRB Tracking # 2016-0811 
 
 
 
Principal Investigators: 
Kenneth Lee, MD – Associate Professor 
 
 
 
 
University of Wisconsin, School of Medicine & Public Health 
 
 
 
 
Department of Radiology 
 
 
 
 
 
John Wilson, MD, MS – Associate Professor (CHS) 
 
 
 
 
Department of Orthopedics and Rehabilitation  
 
 
 
 
 
 
 
Co-Investigators: 
 
Darryl Thelen, PhD- Professor (Tenure) 
 
 
 
 
Department of Mechanical Engineering 
 
 
 
 
 
 
 
 
Bryan Heiderscheit, PhD – Professor (Tenure) 
 
 
 
 
Department of Physical Therapy 
 
 
Funding Sponsor: 
 
National Basketball Association (NBA)/GE Healthcare 
 
Orthopedics and Sports Medicine Collaboration 
 
 
 
 
 
 
 
 
 
 
 

2 
 
Protocol Revision History 
Version Date 
Summary of Revisions Made: 
01 Jun 2016 
Original version 
21 Sep 2016 
Replacing the Biodex Medical Systems with Kiio Sensor for the  
30 Jan 2017 
Clarify the 32 week visit will include completing questionnaires at 
home; the inclusion of a recruitment website. 
18 Apr 2017 
Recruitment efforts are being expanded to include additional sites. 
13 Mar 2018 
Inclusion of 10 healthy/normal subjects.  Added Appendix A (Patellar 
Tendinopathy: Clinical and Biomechanical Assessment Protocol). 
29 Jul 2020 
Clarification to subject recruitment/identification to allow for the use of 
Workbench Research Recruitment Templates in HealthLink; Addition 
of remote consenting procedures 
23 Dec 2021 
Adding a data sharing plan with Dr. Kijowski at NYU 
 
 
 

3 
 
TABLE OF CONTENTS 
 
1.0 
Project Summary/Abstract 
2.0 
Introduction 
3.0 
Study Aims/Study Objectives 
4.0 
Selection of Study Patients 
5.0 
Research Design and Methods 
6.0 
Statistical Considerations 
7.0 
Privacy and Confidentiality 
8.0 
Data and Safety Monitoring 
9.0 
FDA Considerations 
10.0 References 
11.0 Appendix A 
 
 
 

4 
 
1.0 
PROJECT SUMMARY  
 
BACKGROUND AND RATIONALE 
Patellar tendinopathy (PT) is a common disabling overuse injury that is highly prevalent in sports, 
especially amongst jumping athletes. PT affects 32% of elite basketball players and may lead to 
considerable long-term morbidity, resulting in a negative effect on their career with up to 50% of 
athletes forced to quit their sport. Treatment of PT remains challenging, and no currently available 
conservative therapies directly address the underlying pathophysiology of tissue degeneration. 
We will conduct a 52-week double-blinded randomized controlled clinical study to investigate the 
efficacy of PRP and to determine if the intervention truly provides better improvements in pain 
and function and enhanced tissue healing when compared to less expensive minimally-invasive 
treatment options.  
 
OBJECTIVES 
The overall goal of this proposal is to find an effective treatment for PT. To achieve this, we will 
conduct a double-blinded randomized controlled trial (RCT) to investigate if platelet-rich plasma 
(PRP) is effective for treating PT (4-6).  Clinical (pain and function scores) and biomechanical 
(knee strength) measures will be correlated with disease modification changes assessed using 
conventional and novel quantitative magnetic resonance imaging (MRI) and ultrasound (US) 
techniques. 
 
ELIBIGILITY 
This research will target adults, ages 18 to 39 years, diagnosed with chronic (>3 months) patellar 
tendonitis.  Diagnosis will require a clinical examination consistent with PT and/or MRI or 
ultrasound confirmation of PT.  In addition, 10 healthy/normal subjects who are not diagnosed 
with chronic PT will be enrolled into a control cohort. 
 
STUDY DESIGN 
Sixty-six patients with PT will be randomized to one of three study arms. Subjects in Group 1 
(PRP) will receive a single US-guided (USG) injection of 5 mL autologous PRP into the patellar 
tendon, subjects in Group 2 (DN) will undergo USG dry needling of the patellar tendon, and 
subjects in Group 3 (SH) will undergo a sham control USG dry needling in the subcutaneous 
tissue only (not intratendon) at the level of the patellar tendon. The efficacy of the different 
treatment options will be assessed by pain- and function-dependent, PT-specific Victorian 
Institute of Sport Assessment Patella (VISA-P) quality of life scores, Tegner activity level scores, 
knee strength measurements, and conventional and novel MRI and US imaging at baseline, 16, 
32, and 52 weeks post-treatment. 
 
Ten subjects without PT will comprise the healthy/normal or control cohort.  The control subjects 
will undergo the clinical and biomechanical assessments and conventional and novel MRI and 
US imaging during a single study visit. 
 
REQUIRED SAMPLE SIZE  

5 
 
With 20 subjects, the expected power of our study based on hypothesized changes over time and 
the pooled SD of the changes in VISA-P scores. To allow for 10% drop out, we will recruit 22 
subjects per group. Based on the estimated SD for the changes in the VISA-P scores reported in 
the previous study, we are conservatively inflating our pooled SD estimate.  The data collected 
from the 10 control subjects will be used to compare normative data to the data collected from 
the test population. 
 
2.0 
INTRODUCTION 
Patellar tendinopathy is one of the most common disabling conditions of the knee affecting both 
active individuals and competitive athletes (1, 2). PT is a degenerative tendon condition resulting 
in localized anterior knee pain affecting the proximal patellar tendon (7). The etiology of pain 
related to this chronic degenerative disorder remains unclear. The degenerative features of 
tendinopathy, however, are similarly seen in lateral epicondylitis (8), plantar fasciitis (9), and 
Achilles tendinopathy (10). The pathophysiology of PT is thought to be multifactorial, including 
overuse microtrauma, which leads to tendon disorganization and increased vulnerability to further 
injury and possible rupture (7). Chronic pain from PT is costly to elite athletes by reducing peak 
performance, forcing early career retirement, and in the later stages of life, adopting a sedentary 
lifestyle which leads to other chronic diseases such as hypertension and heart diseases (2). Thus, 
finding a reliable treatment option would change the way we approach PT and other chronic 
overuse injuries. Platelet-Rich Plasma: PRP is an emerging minimally invasive treatment option 
that uses concentrated autologous platelets, rich in healing factors (4-6). Recent exponential use 
of PRP has been in the area of sports-related tendon overuse injuries (5, 6, 11-13). Currently, it 
has been estimated that about 100,000 elite athletes are injected with PRP annually, but the 
frequency of use is likely under reported (14). The main growth driver came from the media’s 
attention on well-known professional athletes reporting a quicker and durable return to activity 
after PRP rather than foundational evidence-based decisions from a well-designed randomized 
control trial (RCT). Moreover, clinicians are often faced with increasing demand by their patients 
for PRP, ranging from the weekend warrior to the disabled worker, without much leverage to argue 
for or against its use. There are only two existing but limited two-armed RCTs of PRP that have 
shown equivocal results in chronic overuse injuries (15-18). Despite limited scientific evidence, 
PRP usage has been and will continue to grow exponentially. Therefore, rigorous clinical trials 
are needed to investigate the efficacy of PRP and to determine if the intervention truly provides 
better improvements in pain and function and enhanced tissue healing when compared to less 
expensive minimally-invasive treatment options. PRP Mechanism of Action: Platelets are vital in 
initiating the tissue healing process (12, 19). When activated by injury, platelet alpha-granules are 
released to incite soft tissue healing (20). PRP augments the native healing process at the site of 
tissue degeneration through the action of concentrated healing growth factors such as PDGF, 
VEGF, FGF, and TGF- β1 (12). Fibroblast response and collagen formation occur in the healing 
response phase with tenocyte development and alignment healing (12). In chronic conditions, 
such as PT, few circulating platelets, and therefore low growth factor concentrations, are present, 
especially for tendons that receive only 30% of a muscle’s blood supply (21). Therefore, delivering 
concentrated healing growth factors may benefit hypo-vascular soft tissue structures such as 
tendons. Small clinical studies have reported that PRP injections for PT decrease pain, increase 
function and have the potential to modify diseased tendon (15-18). However, PRP has not been 

6 
 
rigorously evaluated as a therapy for PT.  The proposed project will be the first to assess pain- 
and function-dependent, knee-specific quality of life and in-vivo assessment of compositional, 
ultrastructural, and mechanical properties of PT post-treatment with PRP in a Level 1, RCT with 
subject and assessor blinding. The valuable data gained will significantly add to the knowledge 
base of disease modifying effects of PRP for tendinopathy. Positive findings of PRP compared to 
control would help establish an optimal protocol for the nonsurgical management of PT. In 
addition, no study has assessed the correlation between novel imaging biomarkers with validated 
clinical outcomes in response to therapy, which would provide a powerful imaging assessment 
tool to objectively monitor tissue healing. 
 
 
3.0 
STUDY AIMS/STUDY OBJECTIVES 
The purpose of this research is to find an effective treatment for PT that addresses the underlying 
pathophysiology of tissue degeneration. 
 
3.1 
Specific aims include: 
3.1.1 To evaluate the efficacy of PRP by reporting improved pain- and function-
dependent, PT-specific Victorian Institute of Sport Assessment Patella (VISA-
P) quality of life scores, Tegner activity level scores, and knee strength at 
baseline, 16, 32, and 52 weeks post-treatment.  
3.1.2 To demonstrate treatment-related changes in pathologic imaging features of 
PT using conventional MRI (thickness and T2 signal intensity) and US 
(thickness, echogenicity, and hyperemia).  
3.1.3 To investigate the relationship between changes in novel quantitative MRI 
(single-component and bicomponent ultra-short echo-time T2* (UTE-T2*)) and 
US (shear wave speed (SWS), a proxy for elasticity) parameters of PT and 
clinical and biomechanical improvement following treatment. 
 
 
4.0 
SELECTION OF PATIENTS 
4.1 
Study Population:  This research will enroll 10 healthy normal adults and 66 adults 
diagnosed with chronic patellar tendonitis. 
4.2 
Eligibility criteria (healthy/normal) 
4.2.1 Age between 18 and 39 years 
4.2.2  
 
4.3 
Eligibility criteria (Subjects diagnosed with chronic patellar tendonitis) 
4.3.1 Inclusion criteria 
4.3.1.1 
Age between 18 and 39 years 
4.3.1.2 
Chronic (>3 months) PT 
4.3.1.3 
Clinical examination consistent with PT 
4.3.1.4 
MRI or US confirmation of PT 
4.3.1.5 
Pain score of 3 or greater on a 10-point VAS 
4.3.1.6 
Self-report failure of supervised physical therapy 

7 
 
4.3.1.7 
Self-report failure of at least 2 of the most common treatment 
options for PT (e.g. NSAIDs, relative rest, ice and bracing). 
 
4.3.2 Exclusion criteria (All subjects) 
4.3.2.1 
Inability to comply with study follow-up requirements 
4.3.2.2 
History of bleeding disorders or other hematologic conditions 
4.3.2.3 
Knee pain from other possible etiologies (e.g., degenerative joint 
disease, meniscal tear, ligament injury or reconstruction) 
4.3.2.4 
Full or partial patellar tendon tear 
4.3.2.5 
Current use of anticoagulation or immunosuppressive therapy 
4.3.2.6 
Prior knee trauma requiring medical attention or surgery 
4.3.2.7 
Self-reported pregnancy 
4.3.2.8 
Worker’s compensation injury 
4.3.2.9 
Daily opioid use for pain 
4.3.2.10 
Contraindication to MRI. 
4.3.2.11 
Systemic diseases such as Diabetes and connective tissue 
diseases. 
4.3.2.12 
Prior PRP or DN procedure. 
4.3.2.13 
Women that are pregnant 
 
 
5.0 
Research Design and Methods 
5.1 
Subject Identification and Recruitment:  Potential subjects will be identified through 
the UW Orthopedics/Sports Medicine and UW Physical Therapy Clinics (Research 
Park, East and West) and surrounding Sports Medicine clinics. Study staff with UW 
Health electronic health record (Health Link) access may search patient list templates 
made available to them as part of their research access to Health Link to help identify 
potential subjects for study enrollment evaluation.  Those that appear to meet 
eligibility criteria will be introduced to this research opportunity by someone involved 
in their care.  Patients that agree will be contacted by research team personnel to 
learn more about participation.  Recruitment flyers will also be posted in these 
locations. 
 
The healthy normal subjects will be recruited from the IRB approved database of 
healthy volunteers (2017-0004, Reeder, PI).  These subjects will be contacted by the 
database manager either by phone or email and will be provided with information 
about participation.  Those interested in participating will be referred to a study team 
member to learn more about participation and to be scheduled for an initial study visit. 
Recruitment efforts will also include the use of UW campus mass emails, fliers, UW 
website, social media, and postcards.  Flyers will be posted in the UW Sports 
Medicine Clinics (Research Park and East), UW Physical Therapy Clinics (Research 
Park, East and West), University Health Services, as well as in sport facilities in the 
area (Natatorium, SERF, Health Clubs, etc). Recruitment flyers and postcards will 
also be made available to physical therapists and athletic trainers in the area and at 
other colleges and universities that provide a letter of support for this research.  

8 
 
Recruitment material will be made available at events such as local fun runs/races. 
We will also search medical records using ICD9 codes for potential subjects. One 
mailing will occur to potential subjects, which will include a letter or postcard 
describing the study. All recruitment material will include a brief summary of the 
purpose of the research, the number and duration of study visits, the contact 
information for the research team, and compensation. 
 
5.2 
Consent:  The consent process will occur prior to administration of research 
procedures at the baseline visit.  Potential subjects will meet with a study team 
member to review the information in the consent form including study procedures, 
risks associated with participation, alternatives to participation and whom to contact 
for additional information. After the subject has provided signed consent, any relevant 
laboratory tests will be obtained and confirmed prior to final enrollment in the study. 
Any questions will be addressed prior to the start of any research procedures and all 
subjects will be reminded that participation is optional and they can change their mind 
at any time.  
 
During the COVID-19 pandemic, consent procedures will be conducted by phone, 
when possible, to minimize face-to-face contact subjects have with the research 
team.  A copy of the consent form will be mailed or emailed to subjects prior to the 
scheduled consent phone call. If emailed, the consent form will be encrypted.  A 
study team member will call potential subjects at the scheduled time to review the 
information in the consent form including study procedures, risks associated with 
participation, alternatives to participation and whom to contact for additional 
information.  Any questions will be addressed during the course of the phone call 
and subjects will be encouraged to contact the study team with any questions or 
concerns they might have at any time.  Upon completion of the consent process, a 
copy of the signed consent form will be provided in one of the following ways 
depending on each subject preferences and capabilities: 
• Electronic signature will be provided using DocuSign 
• Subject will be asked to scan a copy of the entire consent document and email it 
back to the study team.  
• Subject will be asked to take a photo of the signature page and email a copy to 
the study team.  
• If subjects are unable to provide an electronic copy of the signed consent form, 
they will be asked to bring a copy of the form to the research visit. 
 
5.3 
Research Procedures:  Subjects enrolled in the chronic PT cohorts will be asked to 
complete four study visits at baseline, 16 weeks, 32 weeks, and 52 weeks.  Subjects 
enrolled in the control cohort will complete 1 study visit. Health questionnaires (VISA-
P Tegner, medication log, side effect log) will be mailed to subjects diagnosed with 
chronic PT only. A table outlining research visits is below. The following research 
procedures will be administered: 
 

9 
 
5.3.1  Randomization:  The 10 healthy/normal subjects will not be randomized and 
will not receive any injections.  The subjects diagnosed with chronic patellar 
tendonitis will be randomized to one of three study arms. Subjects in Group 1 
(PRP) will receive a single US-guided (USG) injection of 5 mL autologous 
PRP using a 22G, 1.5 inch needle and after 20 needle passes targeting 
hypoechoic and hyperemic areas within tendon and bone attachment if 
involved. Subjects in Group 2 (DN) will undergo USG dry needling with 20 
passes using a 22G, 1.5 inch needle targeting hypoechoic and hyperemic 
areas within tendon and bone attachment if involved. Subjects in Group 3 (SH) 
will undergo a sham control USG dry needling with 20 passes using a 22G, 
1.5 inch needle placed in the subcutaneous tissue only (not intratendon) at 
the level of the patella tendon. 
5.3.2 PRP Preparation and Administration (randomized subjects only):  At the 
injection session, a nurse will perform a standard antecubital blood draw 
(15mL) using a 15 mL syringe and an 18G needle from the PRP group at the 
contralateral arm.  The blood draw will occur only once. The study coordinator 
will then place the sample in the Arthrex ACP System and spin the blood 
sample using a two-stage spinning: the 1st separates red blood cells from 
platelets, and the 2nd concentrates the platelets to yield approximately 6mL 
of concentrated, autologous platelets. This layer of platelet rich plasma will be 
placed in the syringe by the centrifuge machine.  Centrifuging will be repeated 
if desired concentration level is not achieved, but this has not occurred 
clinically and we do not anticipate inadequate platelet concentration level. All 
blood and equipment handling will follow universal precautions. 
 
Platelet counts from subjects’ whole blood and PRP processed blood will be 
analyzed. Platelet counts in whole blood vary by individual. The optimal 
quantity of platelets and growth factors required for tissue healing is not 
known, but a clinically effective concentration has been described as being 
greater than 4 times baseline autologous whole blood platelet concentrations 
(Marx RE: Platelet-rich plasma: Evidence to support its use. J Oral Maxillofac 
Surg 2004;62:489-496.). Therefore, platelet concentration yield may have 
important implications in clinical outcome correlation. In order to validate 
consistent platelet concentration yields across subjects, we will sample 1mL 
of whole blood (approximately one lab Vacutainer) and an additional 1 mL of 
platelet rich plasma for lab analysis of platelet to be completed by the UWHC 
Clinical Laboratory. This extra 1 ml of whole blood will be drawn at the same 
time that the 15 ml described above is drawn. After results are analyzed, the 
specimens will be discarded into biohazard waste.   
The plasma poor platelet portion will be discarded in biohazard waste and 
destroyed day of procedure. The 5ml of platelet rich plasma will be injected 
into the subject's PT.  

10 
 
There will be no subject identification number associated with the blood before 
it is placed in the centrifuge system. It is a closed system. It spins the blood 
of one subject only. There is no risk of cross contamination. 
The specimens will not be kept or stored. The blood will be analyzed on the 
same day as the procedure is being performed. This will not require storing of 
the specimen and prevent erroneous labeling of platelet concentration with a 
different subject. 
The skin will be cleansed with an alcohol wipe and Hibicleanse. Lidocaine skin 
heals will be placed for local analgesia. The Patellar tendinopathy area will be 
identified using the US 15-6MHz linear array transducer. Under continuous 
US evaluation, 1 mL of the prepared solution will be injected into the diseased 
area of the PT itself using a 22G, 1.5" long needle. Then, up to 4.0 mL of the 
solution will be peppered along a short segment of the tendon into the areas 
of palpated tenderness and US documented pathology for a total of 5ml. After 
the injections, the subject will rest for 5 minutes. Participants will be 
telephoned after 3 days to enquire about side effects or adverse events.  
Dry Needling (DN) Procedure:  This is a therapeutic procedure that involves 
the same injection procedures under ultrasound guidance as in the PRP group 
but no PRP will be injected inside the patellar tendon. 
Sham (SH) Placebo Procedure: Same needle size is used under ultrasound 
guidance as in PRP and DN groups but we will not inject PRP nor place needle 
inside the patellar tendon. Rather, the needle will be placed in the soft tissue 
next to the patellar tendon. 
5.3.3  Blinding (randomized subjects only):  Subjects and assessors will be blinded 
to the subject group allocation. Subjects in the DN and SH groups will also 
undergo phlebotomy to maintain blinding. Subjects will be identified to study 
personnel using a unique study number only and results of the imaging studies 
will be blinded, batched, and evaluated in a randomized manner. 
5.3.4 Clinical and Biomechanical Assessment (see Appendix A) - All subjects: The 
clinical symptoms of all subjects will be assessed using the validated pain- and 
function-dependent, PT-specific Victorian Institute of Sport Assessment 
Patella (VISA-P) quality of life score and Tegner activity level scale. Knee flexor 
and extensor muscle isometric torque strength will be assessed using an 
isokinetic dynamometer (Kiio Sensor).  Patellar tendon wave speeds will be 
measured with an experimental device during any or all of: strength tests with 
the Kiio sensor, squats, vertical jumps, walking, and running. The 
walking/running tasks will only be performed with subjects who have 
experience with treadmill walking/running. The wave speed measurement 
device will be placed on the surface of the skin. It consists of a piezoelectric 
actuator that induces waves in the tendon and miniature accelerometers that 
track wave propagation. 

11 
 
5.3.5 MRI Protocol:  All subjects will undergo a non-contrast MRI examination of the 
knee on an MR750 3T scanner (GE Healthcare, Waukesha, WI) using an 8-
channel extremity coil.  Subjects will be in the scanner for approximately 45 
minutes. 
5.3.6 US Protocol:  All subjects will undergo an US examination of the patellar tendon 
using both LOGIQ E9 (GE Healthcare Waukesha, WI) and Aixplorer 
(Supersonic Imagine, Aix-en-Provence, France) imaging systems with a 15-
6MHz linear array transducer. Use of two US imaging systems will allow 
comparison of SWS measurements across different vendor platforms, which 
would be important for repeatability in future large-scale clinical trials. Imaging 
will take approximately 60 minutes total to complete. 
5.3.6 Review of Medical Records (All subjects):  
The following information will be collected from the randomized subjects: 
Patient age, height, weight, history of PT pain, duration of symptom related to 
PT, past medical history, past surgical history, medication history and current 
use, medication allergy. 
 
The following information will be collected from the healthy/normal subjects:  
Patient name, height and weight, phone number, lifestyle and health history. 
 
 

12 
 
 
 
*Randomized subjects only 
 
5.4 Risks 
5.4.1 PRP Preparation and Administration:  The main risk associated with this 
process is temporary pain and swelling during the phlebotomy procedure to 
collect the sample and at the injection site during the treatment phase.  Sterile 
technique will be employed during all phases of this process which will 
minimize any opportunity for the sample to be contaminated or the 
collection/injection site to be infected. 
5.4.2 MR Imaging:  The risk from a non-contrast enhanced MRI exam is minimal and 
is primarily related to claustrophobia and discomfort with positioning.  
Thorough 
screening 
will 
be 
completed 
to 
ensure 
subjects 
with 
contraindications to MR are identified.  Only qualified staff will be involved with 
conducting the MR exam. 
5.4.3 US Imaging:  There are no physical risks associated with US imaging. 
5.4.4 Subjects could injure themselves by stumbling or falling while walking or 
running on the motorized treadmill. These tasks will be familiar to subjects who 
are asked to perform them, so the risks are relatively minor. Additionally, there 
is a risk of minor skin irritation from the wave speed measurement device. 
 
5.5 Benefits: There are no benefits expected for the study participant. However, positive 
outcomes from this study would establish an effective non-surgical treatment option for 
PT and demonstrate that disease modification of PRP-treated PT with clinical 
improvements in pain and knee strength is directly related to improvements in the 
imaging features of the healing tendon. 
 
5.6 Criteria for Removal from Study:  Enrolled patients will be removed from the study in the 
following circumstances: 
- 
The patient is unable to complete all research procedures 
- 
The subject withdraws consent 
Procedure 
Measurements 
Assessment Time (weeks) 
0 
16* 
32* 
52* 
Signed Consent and 
Randomization 
 
 
 
 
 
PRP Procedure* 
Collection, processing and administration 
 
 
 
 
VISA-P Tegner* 
Pain and function score of PT 
 
 
 
 
Symptoms/Biomechanics 
Knee Strength testing 
 
 
 
 
MRI 
Single/bi-component UTE-T2*, PT volume 
 
 
 
 
Conventional US 
PT thickness, echogenicity, hyperemia 
 
 
 
 
SWI 
SWS measurements 
 
 
 
 
Medication/PT Log* 
Pain medicine use, eccentric exercise adherence 
 
 
 
 
Side Effects Log* 
Side effects 
 
 
 
 
Exit Interview 
Satisfaction score, qualitative assessment of study 
experience 
 
 
 
 

13 
 
- 
Exclusion criteria are discovered after informed consent has been obtained 
but prior to the research examination. 
 
  
6.0 
Data and Safety Monitoring 
The procedures administered for this research will be done in a manner that is consistent with 
clinical care.  Therefore, an internal monitoring plan that includes the PI and all co-investigators 
will be implemented.  Study team members will meet quarterly to discuss study progress including 
enrollment, data acquisition, and adverse events.  In the event any unanticipated problems occur 
during the course of this research, they will be reported to the Institutional Review Board (IRB) in 
accordance with posted policies. 
 
 
7.0 
Privacy and Confidentiality 
Information about study subjects will be kept confidential and managed according to the 
requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Subjects 
will be assigned a unique study number upon enrollment that will be used to label their research 
data in lieu of directly identifiable information.  All subject data collected during participation in the 
study will be kept in a locked file cabinet within a Department of Radiology office or a password-
protected database that uses departmental servers and will only be accessible to study team 
members.  Coded data and images will be shared with Dr. Richard Kijowski at New York 
University.  The Department of Radiology Radius team will serve as the honest broker and will 
code and share date with NYU. After the study is completed, all data will be de-identified for the 
purposes of research presentations/publications. The study MRI and US examinations will be 
archived on the standard clinical PACS system which is password protected behind the UWHC 
firewall.  The study data and records will be maintained for up to 5 years after the conclusion of 
the study, at which point the PI will destroy the key to the coded identifiers, thus permanently 
anonymizing the data. 
 
 
8.0 
Statistical Considerations 
A similar study involving patients with PT estimated the pooled standard deviation (SD) of the 
changes in VISA-
P score over time 
to be between 15 
and 19 and the 
minimal 
detectable 
change in score 
to be 11.1 (41). Since our subjects will have already completed physical therapy without 
improvement, we hypothesize that the DN and SH groups will marginally improve and that the 
PRP group will significantly improve on the order of 3 times the improvement of the other groups 
over the 1 year follow-up period. With 20 subjects, table 2 shows the expected power of our study 
based on hypothesized changes over time and the pooled SD of the changes in VISA-P scores. 
To allow for 10% drop out, we will recruit 22 subjects per group. Based on the estimated SD for 
N per group 
Change in DN 
Change in SH 
Change in PRP 
Pooled SD 
Power (%) 
20 
5.5 
5.5 
22 
10 
99.9 
20 
5.5 
5.5 
22 
15 
94.8 
20 
5.5 
5.5 
22 
20 
75.1 
20 
5.5 
5.5 
16.5 
10 
94.8 
20 
5.5 
5.5 
16.5 
20 
64.2 
20 
5.5 
5.5 
11 
5 
94.8 
Table 2 

14 
 
the changes in the VISA-P scores reported in the previous study, we are conservatively inflating 
our pooled SD estimate. 
 
 
9.0 
FDA Considerations 
9.1 MRI Hardware/Software: All hardware used to obtain MR images is FDA approved and 
will be used in accordance with the conditions approved by FDA. The investigational 
software being used in image acquisition is designed to stay within the current guidelines 
for MRI safety, established by the FDA.  In addition,  
the investigational software 
does not meet the definition of a Significant Risk Device as outlined by the FDA under 
21 CFR 812.3 as being: 
• 
Intended as an implant and presents a potential for serious risk to the health, 
safety, or welfare of a subject; 
• 
Purported or represented to be for use supporting or sustaining human life and 
presents a potential for serious risk to the health, safety or welfare of a subject; 
• 
For a use of substantial importance in diagnosing, curing, mitigating, or treating 
disease, or otherwise preventing impairment of human health and presents a 
potential for serious risk to the health, safety or welfare of a subject; or 
• 
Otherwise presents a potential for serious risk to the health, safety, or welfare of 
a subject. 
9.2 PRP Preparation and Administration:  The proposed project requires that autologous 
blood be processed at the time of the procedure visit.  The Arthrex Double Syringe (ACP 
– Autologous Conditioned Plasma) System is a commercially available centrifuge 
system that allows for preparation of platelet-rich plasma (PRP) from a small sample of 
blood at the patient’s point of care. The Arthrex Double Syringe ACP System has 
received FDA 510K approval (BK070069, Sept 19, 2008) for the purpose of preparing 
PRP. 
 
 
Platelet-rich plasma meets the FDA’s definition of a biologic, regulated under 21 CFR 
607.3, which covers blood and blood products.  During the processing of autologous 
whole blood from the patient, platelets are concentrated, but there are not any non-
autologous products added to the PRP which significantly alter the biologic 
characteristics of the PRP cellular elements.  In other words, there are no “activating 
agents” (e.g., calcium, thrombin) added to the PRP. 
9.3 The US imaging hardware and software are FDA approved devices that are being used 
in a manner that is consistent with these approvals. We are asserting that the Kiio sensor 
and software are not consistent with the definition of a significant risk device as outlined 
in section 9.1. 
 
 
 
 

15 
 
10.0 
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19 
 
11.0 
Appendix A 
 
Patellar Tendinopathy:  Clinical and Biomechanical Assessment Protocol  
Equipment 
• 
Instrumented strap (elastic neoprene strap with embedded tapper, accelerometers) 
• 
Cabling (assorted BNCs) 
• 
Signal conditioner (Model 480B21, PCB Piezotronics) 
• 
Function generator (SDG1025, SIGLENT) 
• 
Piezo controller (MDT694B, Thorlabs) 
• 
A/D board (NI USB-6218, National Instruments) 
• 
Computer with LabView collection program (Accelerometer.vi) 
• 
Kiio sensor (and possibly laptop to operate) 
• 
Portable force plate (Bertec, FP4060-05-PT) 
• 
Treadmill  
Procedure 
1. Preparatory (prior to subject arrival) (Est 5-10 min) 
a. Set up collection computer, function generator, piezo controller, signal 
conditioner, A/D board, force plate  
2. Set Up (Est 3 min) 
a. Introduction and Brief Description of Tests & Measures 
b. Obtain VAS score 
c. Place instrumented straps over both knees. Secure cables at thigh and waist and 
run them away from subject and instruct subject to perform a few squats to allow 
straps to settle into position  
i. 
Use Coban or Velcro strap on thigh, clip on belt 
3. Signal Check (Est 5 min) 
a. Record squat trial (subject performs squats for 4 seconds, ~ 2 reps) 
i. 
Verify signal integrity using Matlab software (i.e. click “run”): wave speeds 
between 20 and 100 m/s, minimal dropouts 
b. Record passive flexion trial (subject bends knee, open-chain, for 4 seconds) 
i. 
Verify signal integrity using Matlab software (i.e. click “run”): wave speed 
does not vary more than 15m/s 
c. If poor signals, shift knee strap so that accelerometers are aligned with mid-
patellar tendon.  Repeat.  
4. Quadriceps Strength (Est 6 min) 
a. Seated Isometric Knee Extension using Kiio system to measure force 
i. 
Position subject at end of mat table 
ii. Adjust Kiio system tether such that tension is present with subject’s knee 
positioned in 60 degrees of flexion 
iii. Explain to subject that the goal of this task is to kick out as HARD as 
possible for 3-5 seconds 

20 
 
1. Uninvolved Limb Tested First 
a. Warm Up repetitions (50, 75, 90% of max) 
b. Rest 30 sec 
c. 2 maximal knee extension trials (60 sec rest between 
trials) 
 
Initiate trials by counting down (“3, 2, 1…”) 
 
Strong verbal encouragement during trial to elicit 
maximal knee extensor torque (“Kick kick kick/Go 
Go Go Go!”) 
2. Repeat procedure with involved limb 
a. VAS score following 2nd rep 
5. Vertical Jumps (Est 8 min) 
a. Double Leg Countermovement Jump (Est 3 min) 
i. Subject positioned with both feet in center of the force plate, feet 
approximately shoulder width apart 
ii. Subject instructed to place hands on hips and perform countermovement 
jump beginning from standing position with the goal of maximizing vertical 
jump height (jump as HIGH as you can) 
1. Warm Up (3-5 submaximal jumps) 
2. Rest 30 sec (turn on tapper) 
3. 3 maximal jump trials (30 sec rest between each trial) 
a. Initiate/Run Collection Program at start of each trial 
b. To constitute a valid trial, subject must land in center of 
force plate and stabilize for at least 1 second 
iii. VAS score following 3rd rep 
b. Single Leg Countermovement Jump (Est 5 minutes total) 
i. Subject positioned with one foot on force plate 
ii. Subject instructed to place hands on hips and perform single leg 
countermovement jump beginning from standing position with the goal of 
maximizing vertical jump height (jump as HIGH as you can), and to land 
on the same leg 
1. Uninvolved Limb Tested First 
a. Warm Up (3-5 submaximal jumps) 
b. Rest 30 sec (turn on tapper) 
c. 3 maximal jump trials (30 sec rest between each trial) 
i. Initiate/Run Collection Program at start of each trial 
ii. To constitute a valid trial, subject must land on 
single leg in center of force plate and stabilize for at 
least 1 second 
2. Repeat with involved limb 
a. VAS score following 3rd rep 
6. Gait (Est 5 min) 
a. Walking (3.3 mph) (Est 2 min) 
i. 
Position subject on treadmill (TM); subject  instructed to walk normally (20 
seconds warmup/set speed) 

21 
 
1. Turn on tapper (button on Piezo Controller) 
2. Run Collection Program (8 sec) 
3. Repeat 3 times while subject walks continuously 
4. Obtain VAS score 
b. Running (6.0 mph) (Est 3 min) 
i. 
Position subject on TM, instructed to run normally (30 seconds 
warmup/set speed) 
1. Turn on tapper (button on Piezo Controller) 
2. Run Collection Program (8 sec) 
3. Repeat 3 times while subject runs continuously 
4. Obtain VAS score 
ii. If subject is able, repeat collection with TM speed of 7.5 mph 
7. Record tapper, accelerometer locations (Est 2 min) 
a. Subject sits with knees flexed to 90 deg 
i. 
Sleeve removed, locations of tapper and accelerometers on skin marked 
1. Tapper and accelerometers are strapped tightly enough that they 
leave slight indentations in skin.  Measurements are easy.  
b. Measure distance to each mark from apex of patella and tibial tuberosity 
 
Current Estimated Collection Time: 
Prep (5-10 min) 
Setup (3 min) 
Signal Check (5 min) 
Vertical Jump (8 min) 
Quad strength (6 min) 
Gait (5 min)  
Record Tapper/Accel locations (2 min) 
Cleanup (5 min) 
Estimated Collection Time (with subject):  29 min 
Estimated Total Collection Time (with prep/cleanup):  40-45 min