"Effect of Intraoperative Application of Autologous PRP on Post Operative Morbidity in ACL Reconstruction Using Autologous Bone Patellar Tendon Bone Graft Harvest"
Phase: PHASE4
Conditions: Post Operative Pain
Sponsor: Brian Walters

 
 
Effect of intraoperative application of autologous PRP on post 
operative morbidity in ACL reconstruction using autologous 
bone patellar tendon bone graft harvest 
 
 
 
Principal Investigator: Dr. Stephen J. Nicholas 
Chief: Nicholas Institute of Sports Medicine 
Surgicare of Manhattan 
Email: snicho55@aol.com 
Coordinator: Brian Walters, 646-419-4449; briwalters52@gmail.com 
 
 
IRB: The Feinstein Institute for Medical Research 
North Shore Long Island Jewish Health Systems 
Office of the Institutional Review Board 
350 Community Drive, 4th Floor 
Manhasset, NY 11030 
Phone: 516-562-3101 
Fax: 516-562-3105 
Email: irb@nshs.edu 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Introduction 
 
Platelet-rich plasma (PRP) has been advocated as a way to introduce increased 
concentrations of growth factors and other bioactive molecules to injured tissues in 
an attempt to optimize the local healing environment. PRP has been used 
extensively in dental and cosmetic surgery for almost 30 years and its safety and 
efficacy in these areas is well established. Recently, there has been increasing 
evidence that the increased levels of autologous bioactive proteins provided by the 
concentrated platelets in PRP could enhance tissue repair and regeneration in a 
variety of orthopaedic pathologies (4). Currently PRP is being used in almost all 
areas and pathologies in orthopaedics with a paucity of high-level evidence to 
support its use. Initially popularized for its effectiveness in the treatment of lateral 
epicondylitis and other tendinopathies (1,9,5), PRP’s indications have recently 
broadened to acute conditions such as muscle or ligamentous injury and ankle 
sprains (2,11) where it has been proven effective at decreasing pain. ACL repair 
using autologous BPTB grafts is widely used in ACL reconstruction due its excellent 
healing potential and lack of risk of disease transmission that accompanies 
cadaveric graft use. The main drawback or poor outcome in autologous BPTB 
reconstruction has been donor site morbidity manifest as anterior knee pain and 
pain with kneeling activity. Animal studies and clinical results of the use of PRP in 
ACL reconstruction have been mixed but do show some promise in the areas of graft 
incorporation and donor site morbidity (7,8,10,12,13).  There is currently a paucity 
of well-designed, prospective, randomized, blinded (Level 1) clinical studies that 
carefully and comprehensively investigate the role of PRP in ACL surgery. 
Specifically, ACL reconstruction using BPTB harvest and the role of PRP in 
decreasing postoperative pain at the donor site. Given the need for a highly powered 
study to demonstrate the clinical efficacy of PRP in ACL reconstruction, we have 
designed a prospective, randomized, level 1, double-blinded study to evaluate the 
effects of PRP on the specific outcomes of donor site pain and radiographic 
measures of graft healing and incorporation.  
 
Specific Aim 
 
The aim of this study is to evaluate the efficacy of intra-operatively applied 
autologous PRP in reducing donor site morbidity and increasing radiographic 
healing in ACL reconstruction using autologous BPTB. 
 
Drug Information 
 
Platelet-rich plasma (PRP) is blood plasma that has been enriched with platelets. As 
a concentrated source of autologous platelets, PRP contains (and releases through 
degranulation) several different growth factors and other cytokines that stimulate 
healing of bone and soft tissue. The efficacy of certain growth factors in healing 
various injuries and the concentrations of these growth factors found within PRP 
are the theoretical basis for the use of PRP in tissue repair. The platelets collected in 

 
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PRP are activated by the addition of thrombin and calcium chloride, which induces 
the release of these factors from alpha granules. The growth factors and other 
cytokines present in PRP include:  
 
• Platelet-derived growth factor 
• Transforming growth factor beta 
• Fibroblast growth factor 1 
• Insulin-like growth factors 1,2 
• Vascular endothelial growth factor 
• Epidermal growth factor 
• Interleukin 8 
• Keratinocyte growth factor 
• Connective tissue growth factor 
 
There are, at present, two methods of PRP preparation approved by the U.S. Food 
and Drug Administration. Both processes involve the collection of whole blood that 
is anti-coagulated with citrate dextrose before undergoing two stages of 
centrifugation designed to separate the PRP aliquot from platelet-poor plasma and 
red blood cells. In humans, the typical baseline blood platelet count is approximately 
200,000 per uL. Therapeutic PRP concentrates the platelets by roughly five-fold. 
There is however broad variability in the production of PRP by various 
concentrating equipment and techniques. 
 
In humans, PRP has been investigated and used as clinical tool for several types of 
medical treatments, including nerve injury, tendinitis, cardiac muscle injury, bone 
repair and regeneration, plastic surgery, and oral surgery. PRP has also received 
attention in the popular media as a result of its use in treating sports injuries in 
professional athletes. Currently, no PRP type reagents are being used in patients 
undergoing autologous BPTB ACL reconstruction as a part of the standard care of 
patients.  
 
Taking all of the above into account and in keeping with current handling in 
orthopaedic surgeries where PRP is handled, the Arthrex ACP System for harvesting 
and preparing PRP under sterile conditions in the OR will be used. This will require 
the donation of approximately 10cc of patients venous blood drawn prior to the 
start of the case-in the OR, after patients have been placed under general anesthesia, 
and under sterile conditions. The Arthrex ACP system will be utilized to prepare the 
sample and the 3-5ml harvest of supernatant will be utilized to apply the PRP at the 
end of the case.  
 
The equipment needed: ACP/Double Syringe with Cap, Anticoagulant ACD-A: 50ml, 
Centrifuge, rotor set, Bucket, Bucket Cap, and counterbalance will be provided by 
Arthrex.  
 
 

 
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Research and Design Methods: 
 
A. Study Design:  This is a single-center, prospective, randomized, double-
blinded study utilizing patients undergoing ACL reconstruction with 
autologous bone patellar tendon bone graft harvest under the care of one of 
two surgeons (SJN or BB) at Surgicare of Manhattan. 
 
B. Inclusion Criteria: 
• Primary ACL Reconstruction 
• Outerbridge </= 2 at time of surgery 
• Minimum follow up of two years 
• No ligamentous secondary injury  
• Willingness to participate in the study, including follow up at regular 
intervals and completion of subjective questionnaires 
 
C. Exclusion Criteria: 
• Any previous knee injury 
• Any previous history of patellofemoral pain/anterior knee pain 
• Outerbridge classification 3 or higher 
• Revision ACL 
• Diabetic or smoker 
• Workers compensation patient 
• Any patient with limited English proficiency 
• Pregnant or nursing women 
 
D. Patient Enrollment: Enrollment will be based on the above inclusion criteria. 
We plan to enroll approximately 100 patients with 50 randomized to the 
treatment arm, and 50 to the control. Our power analysis was based upon 
previous studies on post-operative morbidity in patients undergoing ACL 
reconstruction with autologous bone patellar tendon bone graft harvest. To 
establish significance, we need 35 patients per group to detect a 20% 
difference in anterior knee pain with an α = .05 and a power of 80%. 
Assuming a loss to follow up of up to 30% at two years, adequate sample 
recruitment was determined to be 50 per group or 100 total. (This 
calculation and appropriate references are described in this protocol: section 
I; pg 21) 
 
E. Recruitment Procedure:  Patients undergoing an ACL reconstruction with 
autologous BPTB graft harvest will be asked prior to surgery for their 
participation in this study after considering the inclusion/exclusion criteria. 
Informed consent will be obtained any time after the patient is booked for 
surgery (usually 2-3 weeks before surgery) and before the day of surgery 
(not on the day of surgery). Patients will be blinded to treatment 
randomization. 

 
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F. Data Collection: Data collection will be prospective 
 
 
• Pre-operative data collection requiring patients to fill out a form will 
include: the IKDC Demographic Form (see below) which will require 
approximately 5 minutes of time during a preoperative office visit. 
 
 
IKDC Demographic Form 

 
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IKDC Demographic Form p.2 

 
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• Pre–operative objective data collection will include: 
 
o Time from injury to surgery, and a radiographic grading of 
osteoarthritis using the Kellgren-Lawrence classification scale 
performed by one senior musculoskeletal radiologist (DK). 
 
• Intra-operative data collection will include: Outerbridge classification 
of medial, lateral, patellofemoral compartments osteoarthritis, blood 
loss, time of surgery, tourniquet time, meniscal pathology and its 
treatment. A sample of intraoperative data sheets is listed below: 

 
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• Post-operative data collection will include both subjective and 
objective outcomes measures.  
 
o Subjective outcomes of donor site morbidity will include VAS 
for ADL’s, VAS for kneeling, IKDC subjective knee evaluation 
form, and a return to sports/subjective performance 
questionnaire. Each post operative office visit will require 
approximately 10 minutes of patient time to fill out the 
subjective questionnaires. 
 
▪ Collected at 14days and 1,3,6,12,18 and 24 months 
 
Example of how a VAS questionnaire is converted to numerical data points:  
 
 
 
 
 
 
 

 
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IKDC Subjective Knee Evaluation Form 
 
 
 

 
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Return To Sports 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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o Objective outcomes measures will be collected in the form of 
radiographic and clinical data collection. (Appendix C) 
 
▪ Triple view radiographic series of the knee at 3 months 
postop to assess tunnel placement and donor site 
healing by one blinded senior radiologist (DK). 
 
▪  Post-op MRI at 6 months to assess degree of donor site 
healing. Interpreted by one blinded senior 
musculoskeletal radiologist  (DK) 
 
▪ Objective clinical assessments will include IKDC knee 
examination form scores, ROM measured with 
goniometer, and quadriceps strength. This data will be 
collected by an independent researcher (RR, SS) also 
blinded to treatment. In order to protect the blinding of 
the study, the senior surgeon(s) (SJN or BB) will 
examine the patients post operatively but their 
assessments will not be included in the clinical data 
collection.  
 
 
Data Collection Sheet- Objective 
 
 
Pt. ID # 
XR tunnel 
placement 
XR Donor 
Site Healing 
MRI Donor 
Site Healing 
IKDC 
Quadriceps 
Strength 
ROM 
001 
 
 
 
 
 
 
002 
 
 
 
 
 
 
003 
 
 
 
 
 
 
004 
 
 
 
 
 
 
005 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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IKDC Objective Knee Evaluation Form 
 
 
 
 
 
 
 
 
 
 

 
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G. Experimental Design 
 
Patients will be randomized using a computer generated randomization table 
(simple randomization) into one of two treatment arms:  
 
(1) Autologous BPTB ACL reconstruction followed by application of 
PRP soaked bone chips = Treatment 
 
 
(2) Autologous BPTB ACL reconstruction = Control 
 
The patient, research personnel and individuals collecting all objective 
outcome measures will be blinded to the randomization. The operating 
surgeons (SJN or BB) will evaluate the subjects pre and post operatively but 
will not contribute any of their objective data collection to the study. 
Randomization and patient assignments will be done through sequentially 
numbered opaque sealed envelopes by the circulating nurse in the OR at the 
time of surgery. The randomization will not be stratified according to 
surgeon but rather-according to treatment arm. Randomization information 
will then be recorded and placed into a sealed envelope with the patients’ 
randomization ID and deposited into a locked reception box. This box will 
only be opened upon completion of the study.  
 
H. Research Procedure 
 
ACL reconstruction  
 
Will be performed using standard approved surgical technique. The 
surgeries will be performed by one of two senior surgeons (SJN or BB) and 
diagnostic arthroscopy will verify the inclusion criteria are met (no 
additional ligamentous injury, no osteochondral defect, and Outerbridge 
classification grade 2 or lower). After fixation of the graft and just prior to 
closure, the senior attending (SJN or BB) and any other research personnel 
present will leave the room so that application of either PRP soaked 
cancellous bone chips or non-treated cancellous bone chips to the graft 
harvest site can be performed in a manner that will maintain blinding. A 
surgical fellow or resident who will not be present for any portion of the 
outcomes data collection will do this and therefore, will not compromise the 
blinding of the study. The Paratenon will be closed over the material thus 
sealing it within the donor site and the wound will be closed using normal 
guidelines.  
 
 
 
 
 
 
 
 

 
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PRP Preparation 
 
 
The PRP will be prepared directly in the operating room prior to the 
surgical intervention but after the patient has been placed under general 
anesthesia. The Arthrex ACP Double Syringe system will be used according to 
their manufacturing guidelines. The blood sample will be obtained by the 
anesthesiologist at the start of the case, just after the patients have been 
placed under general anesthesia via the same IV access utilized to administer 
the anesthesia. The Anesthesiologist will have no role in the data collection 
or surgical intervention aspect of the study. As the blood will be drawn after 
patients are asleep, they will remain blinded to their treatment arm and only 
those in the treatment arm will have blood withdrawn and no additional IV 
access will be necessary.  
 For each patient in the treatment arm of the study, the 
anesthesiologist will withdraw 10cc of venous blood prior to the surgeon or 
research assistants having entered the room. The blood sample will be given 
to an OR assistant to prepare prior to the start of the case. The 10cc of venous 
blood will be mixed together with 1 cc of ACD-A (citrate anticoagulant) and 
centrifuged for 5 min at 1500 rpm. The blood sample will separate into red 
blood cells and a supernatant “buffy coat” layer containing platelets (PRP) 
and white blood cells. This Leukocyte rich prp layer will be approximately 3-
5cc in volume and will be aspirated into the inner smaller diameter syringe 
of the double syringe system. Lastly, the PRP phase will be mixed together 
with .25cc of CaCl2 and placed within a sterile specimen cup that is covered 
in aluminum foil so that no one can see what is inside. Once the graft has 
been harvested, the autologous cancellous bone chips retrieved will be added 
to the specimen cup by the scrub technician. The PRP and cancellous bone 
chips will be mixed together in a separate sterile preparatory area of the 
operating room. They will be left to soak within the concealed container until 
the end of the case when the chips and PRP will be placed together within the 
patellar bony defect. A separate member of the staff who is not involved in 
any of the postoperative data collection measures will do this. Prior to 
placement of the PRP soaked cancellous chips within the wound and closure, 
the primary surgeon (SJN or BB) and any personnel present who will also be 
present during the post operative time frame for outcomes measurements 
will leave the room.  
Concealing the contents of the specimen cup, preparing the PRP and 
adding it to the specimen cups prior to the presence of any active participant 
in the study (Senior surgeon or otherwise) entering the room, and adding the 
prp soaked bone chips to the patellar defect without any active study 
members in the room ensures blinding.  
 

 
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I. Statistical Analysis/Data Management 
 
We plan to enroll approximately 100 patients with 50-treatment/50 
controls. Power analysis was based upon previous studies examining 
kneeling pain using a VAS in patients undergoing ACL reconstruction with 
Autologous Bone Patellar Tendon Bone graft harvest. Feller et al (2001) 
reported kneeling pain to be 4.5+/-2.1 4 mo. after surgery, Wipfler et al 
(2011) reported kneeling pain to be 1.6+/-0.7 1 yr after surgery, and Siebold 
et al (2006) reported kneeling pain to be 4.0+/-3.1 3.8 yr after surgery (mean 
+/-SD reported). A 2-point difference in kneeling pain between groups would 
be regarded as clinically significant. The between subject SD for kneeling 
pain of averaged 2.0 for the 3 studies cited above with an upper limit of 
approximately 3.0. Therefore we conservatively based the sample size 
estimate to demonstrate a 2.0 difference in VAS pain between groups on a SD 
of 3.0. It is estimated that with 35 patients per group there will be 80% 
power to detect a 20% difference in kneeling pain (2 points on a 10 point 
scale) at an alpha level of 0.05. This estimate was calculated using the 
equation described by Kirkwood et al (1988). 
 
Assuming a loss to follow up of up to 30% at two years, adequate sample 
recruitment was determined to be 50 per group or 100 total. 
 
 
References Cited for Power Analysis 
 
1: Siebold R, Webster KE, Feller JA, Sutherland AG, Elliott J. Anterior 
cruciate ligament reconstruction in females: a comparison of hamstring 
tendon and patellar tendon autografts.  
Knee Surg Sports Traumatol Arthrosc. 2006 Nov;14(11):1070-6. 
Epub 2006 Jun 7. PubMed PMID: 16758236. 
 
2: Wipfler B, Donner S, Zechmann CM, Springer J, Siebold R, Paessler HH. 
Anterior cruciate ligament reconstruction using patellar tendon versus 
hamstring tendon: a prospective comparative study with 9-year follow-up.  
Arthroscopy. 2011 May;27(5):653-65. PubMed PMID: 21663722. 
 
3: Feller JA, Webster KE, Gavin B. Early post-operative morbidity following 
anterior cruciate ligament reconstruction: patellar tendon versus hamstring 
graft.  
Knee Surg Sports Traumatol Arthrosc. 2001 Sep;9(5):260-6. PubMed 
PMID:11685356. 
 
4:Kirkwood BR (1988). Calculation of required sample size. In Essentials of 
Medical Statistics. pp 191-200. Oxford. Blackwell Scientific Publications.  

 
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The secondary outcome measures are objective and include radiographic 
evidence of graft site healing and clinical objective measurements. The 
primary and secondary outcomes measures for the two groups will be 
statistically analyzed to evaluate for any differences between the two groups 
over time using mixed model analysis of variance with Group (PRP vs. no 
PRP) and the between subjects factor and Time (14d, 1,3,6,12,18 and 24 
months post op) as the within subjects factor. Bonferroni corrections will be 
used for between group or between time pair-wise planned comparisons.   
 
The de-identified data will be entered into an Excel spreadsheet and 
maintained on a password-protected computer. Once data collection is 
complete, the principal investigator (SJN) and/or his research assistant (MM) 
will destroy the master hard copy of identifier codes. Confidentiality of data, 
data integrity, review of data and study quality will be monitored by the 
principal investigator and/or his research assistant. Baseline data, 
demographic data, primary and secondary outcomes will be analyzed using 
summary statistics, standard deviations and 95% confidence intervals for 
quantitative data. Qualitative data will be assessed using frequencies and 
percentages.  
 
J. Informed Consent: 
Informed valid written consent will be obtained from all patients at the time 
of enrollment. This will be in accordance to IRB consent forms 
 
K. Potential Risks & Discomforts: 
 
a. Platelet Rich Plasma: Since PRP is a formulation created entirely from the 
participants own blood, the complications and risks are extremely low. 
The anesthesiologist who prepares the blood is highly skilled and will 
carefully sterilize the skin prior to obtaining the sample. Another side 
effect that is common is an initial increase in pain and inflammation at the 
site where the PRP is injected. This occurs because the platelets and blood 
sample contain natural chemicals that stimulate the immune system. This 
type of complication is short lived and when it does occur, is treated 
effectively with pain medication and anti-inflammatory medications, such 
as Ibuprofen. PRP is not recommended for individuals who have a known 
bleeding disorder (bleed easily) or are on a medication known to thin the 
blood such as Coumadin or Lovenox. This makes sense because these 
patients are more likely to bleed than an individual who has normal 
bleeding characteristics.  
b. Blood Draw: There are no major risks of having blood drawn in this study. 
Participants will be fully anesthetized while the blood is drawn, which 
therefore mitigates the pain of the injection. In addition, the blood will be 

 
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drawn through the IV that is already being placed as part of their 
scheduled surgery. Therefore, participants will not experience any 
additional bruising or discomfort as a result of participating in this study. 
c. X-ray: As a result of x-ray imaging, participants will be exposed to 
radiation. Since having x-rays is a standard part of post ACL 
reconstruction surgery, participants will not be exposed to any 
additional radiation for participating in this study.  
d. Magnetic Resonance Imaging: Since MRI machines use magnets and 
radio waves to take images of the body, participants are not subjected 
to any radiation. However, participants might experience discomfort 
with having to lie on a narrow enclosed couch for 15 minutes as the 
machine takes the images. In addition, the machine produces loud 
tapping noise that might be cause discomfort to the participants. The 
only caution for this test is to ensure that participants have no metal 
on or in their body since the machine might disrupt them.  
e. Survey: There are no risks associated with completing the survey. 
Participants might feel discomfort from completing the survey as a 
result of the questions being asked, but they are reminded that they 
can stop completing them at any time.  
f. Breach of confidentiality: Although it is unlikely, there is a small risk 
that there can be a breach of confidentiality if patient information is 
disclosed to unauthorized individuals.  All measures to ensure patient 
confidentiality will be employed.  Data will be de-identified and 
entered into a password-protected computer.  Only the principal 
investigator (SJN) and research assistant (MM) will have access to 
their data with patient identifiers. 
 
L. Data Safety Monitoring Board: The data safety monitoring plan for this study 
will involve patient follow-ups and interim analysis. At each follow-up 
session, the investigator will assess healing of both the donating and 
recipient sites. If any infections are present, they will be addressed as per 
standard of care which involves cleaning the area arthroscopically. The 
investigator will also perform an interim analysis after half of the accrual 
goal is achieved. At this point, study data will be reviewed by the investigator 
to ensure patient safety and the continued validity of the study. 
 
M. Potential Benefits: 
The participants randomized to receive PRP in this study may directly 
benefit by having decreased healing time and decreased post operative pain, 
specifically anterior knee pain common to patients in the postoperative time 
frame following autologous BPTB reconstruction of their ACL. The study may 
provide knowledge on the benefits of PRP in graft site healing and patient 
satisfaction following ACL reconstruction. 
 
N. Discontinuation of Study/Subject Withdrawal 

 
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A patient may be withdrawn from the study due to lack of follow up or 
voluntary withdrawal. The study may also be discontinued at any time 
depending on the circumstances and any adverse events on the discretion of 
the investigating personnel and the IRB. 
 
O. Adverse Events 
If the patient has any adverse effects from being in the study, they will 
receive medical care and treatment as needed from the North Shore-Long 
Island Jewish Health System. However, the patient will be responsible for the 
costs of such medical treatment, directly or through their medical insurance 
and/or other forms of medical coverage. No money will be given to the 
patient. All adverse events will be reported as necessary, per NSLIJ IRB 
policy.  
 
P. Confidentiality 
Each subject will be assigned a unique number in consecutive order, not 
derived from any patient identifiers, known as a code number.  These code 
numbers will be listed on a “Master Subject Log” and will serve to link the 
subject's code number with their name, (date of birth and medical record 
number).  The code numbers will be the only patient identifier collected on 
the Data Collection Sheet.  At the conclusion of this investigation, the Master 
Subject Log will be destroyed to ensure patient confidentiality.  Data will be 
compiled in a Microsoft Excel spreadsheet which will be password protected 
to maintain patient confidentiality. All other study documents will be kept in 
the office of Stephen J. Nicholas. There will be no disclosure of the PHI.  Paper 
copies of the study documents will be created only as needed and shown only 
to the investigators listed in the study personnel and will be destroyed 
immediately after they are no longer needed.  Patient data (unidentified) will 
be contained on a password-protected computer.  Only the investigators will 
have access to the data.  In the event that the results of this study are 
published or used in any presentations, all information will be de-identified.  
It will be impossible to recognize individuals. 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Q. References 
 
1. de Vos RJ, Weir A, van Schie HT, Bierma-Zeinstra SM, Verhaar JA, Weinans 
H, Tol JL. Platelet-rich plasma injection for chronic Achilles tendinopathy: 
a randomized controlled trial. JAMA. 2010 Jan 13;303(2):144-9. 
 
2. Everts et al Exogenous application of platelet-leukocyte gel during open 
subacromial decompression contributes to improved patient outcome. A 
prospective randomized double-blind study. Eur Surg Res. 2008 
 
3. Fleming BC, Spindler KP, Palmer MP, Magarian EM, Murray MM. Collagen-
platelet composites improve the biomechanical properties of healing 
anterior cruciate ligament grafts in a porcine model. Am J Sports Med. 
2009;37(8):1554-63. PMCID: 2796133.  
 
4. Foster TE, Puskas BL, Mandelbaum BR, Gerhardt MB, Rodeo SA. Platelet-
rich plasma: from basic science to clinical applications. Am J Sports Med. 
2009;37(11):2259-72.  
 
5. Gosens T, Peerbooms JC, van Laar W, den Oudsten BL. Ongoing positive 
effect of platelet-rich plasma versus corticosteroid injection in lateral 
epicondylitis: a double blind randomized controlled trial with 2-year 
follow-up. Am J Sports Med. 2011 Jun;39(6):1200-8. 
 
6. Joshi SM, Mastrangelo AN, Magarian EM, Fleming BC, Murray MM. 
Collagen-platelet composite enhances biomechanical and histologic 
healing of the porcine anterior cruciate ligament. Am J Sports Med. 
2009;37(12):2401-10. PMCID: 2856313.  
 
7. Nin JR, Gasque GM, Azcarate AV, Beola JD, Gonzalez MH. Has platelet-rich 
plasma any role in anterior cruciate ligament allograft healing? 
Arthroscopy. 2009;25(11):1206-13.  
 
8. Orrego M, Larrain C, Rosales J, Valenzuela L, Matas J, Durruty J, Sudy H, 
Mardones R. Effects of platelet concentrate and a bone plug on the healing 
of hamstring tendons in a bone tunnel. Arthroscopy. 2008;24(12):1373-
80.  
 
9.  Peerbooms JC, Sluimer J, Bruijn DJ, Gosens T. Positive effect of an 
autologous platelet concentrate in lateral epicondylitis in a double-blind 
randomized controlled trial: Platelet-rich plasma versus corticosteroid 

 
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injection with a 1-year follow-up. Am J Sports Med. 2010 Feb;38(2):255-
62. 
 
10. Radice F, Yanez R, Gutierrez V, Rosales J, Pinedo M, Coda S. Comparison of 
magnetic resonance imaging findings in anterior cruciate ligament grafts 
with and without autologous platelet- derived growth factors. 
Arthroscopy. 2010;26(1):50-7.  
 
11. Randelli PS, Arrigoni P, Cabitza P, Volpi P, Maffulli N. Autologous platelet 
rich plasma for arthroscopic rotator cuff repair. A pilot study. Disabil 
Rehabil. 2008;30(20-22):1584-9.  
 
12. Sanchez M, Anitua E, Azofra J, Prado R, Muruzabal F, Andia I. 
Ligamentization of tendon grafts treated with an endogenous preparation 
rich in growth factors: gross morphology and histology. Arthroscopy. 
2010;26(4):470-80.  
 
13. Silva A, Sampaio R. Anatomic ACL reconstruction: does the platelet-rich 
plasma accelerate tendon healing? Knee Surg Sports Traumatol Arthrosc. 
2009;17(6):676-82.  
 
14. Spindler KP, Murray MM, Carey JL, Zurakowski D, Fleming BC. The use of 
platelets to affect functional healing of an anterior cruciate ligament 
(ACL) autograft in a caprine ACL reconstruction model. J Orthop Res. 
2009;27(5):631-8. PMCID: 2752673.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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APPENDIX A 
 
Data Collection Sheet- Demographics 
 
Pt ID # SEX 
AGE 
BMI 
OC 
TTI 
 001 
 
 
 
 
 
 002 
 
 
 
 
 
 003 
 
 
 
 
 
 004 
 
 
 
 
 
 005 
 
 
 
 
 
 
 
Demographic characteristics 
 Age 
 Sex (female/male) 
 Weight (kg)  
 Height  
 Outerbridge Classification (OC) 
 Estimated time from injury to surgery (Time To Intervention TTI) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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APPENDIX B 
 
Data Collection Sheet- Subjective 
 
Pt. ID 
# 
VAS ADL 
VAS Kneeling 
RSQ 
IKDC 
001 
 
 
 
002 
 
 
 
003 
 
 
 
004 
 
 
 
005 
 
 
 
 
Return to Sports Questionnaire 
• 6months post op 
Visual Analog score for ADL 
• 14d, 1, 3, 6, 12, 18, 24 months follow up 
Visual Analog score for Kneeling:  
• 14d, 1,3,6,12,18, 24 months follow up 
IKDC subjective knee evaluation form 
• 14d, 1,3,6,12,18, 24 months follow up 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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APPENDIX C 
 
Data Collection Sheet- Objective 
 
Pt. ID # 
XR tunnel 
placement 
XR Donor 
Site Healing 
MRI Donor 
Site Healing 
IKDC  
Quadriceps 
Strength 
ROM 
001 
 
 
 
 
 
002 
 
 
 
 
 
003 
 
 
 
 
 
004 
 
 
 
 
 
005 
 
 
 
 
 
 
 
Radiographic healing 
• 3 months – XR assessment of tunnel placement and donor site healing 
• 6 months - MRI Assessment of Donor Site Healing  
IKDC Knee examination form 
• 14d, 1,3,6,12,18 and 24 months follow up 
ROM Measurements 
• 14d, 1,3,6,12,18 and 24 months follow up 
Quadriceps Strength 
• Dynamometry scale