Use of Platelet Rich Plasma After Arthroscopic Debridement for Triangular Fibrocartilage Complex Tears
Phase: NA
Conditions: Arthroscopic Surgery, Triangular Fibrocartilage Complex Injury
Sponsor: Cedars-Sinai Medical Center

USE OF PRP AFTER ARTHROSCOPIC 
DEBRIDEMENT FOR TFCC TEARS 
Protocol Number: Pro53449 
National Clinical Trial (NCT) Identified Number:  NCT03805698 
Principal Investigator: Dr. David Kulber 
Sponsor: Cedars-Sinai Medical Center 
Sponsor means an individual or pharmaceutical or medical device company, governmental agency, 
academic institution, private organization, or other organization who takes responsibility for and 
initiates a clinical investigation.  
Device Donations By: Musculoskeletal Transplant Foundation 
Version Number:  v2 
03 October 2018 
 
 
Summary of Changes from Previous Version: 
Affected 
Section(s) 
Summary of Revisions Made 
Rationale 
6.1.2, 6.1.3, 
6.2 
Medical photography added 
Per MCA review 
9.6 and 
throughout 
Sample size per justification 
Per Biostats Review 

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Table of Contents 
STATEMENT OF COMPLIANCE ................................................................................................................................................ 4 
1 
PROTOCOL SUMMARY ........................................................................................................................................................ 4 
1.1 
Synopsis ............................................................................................................................................................................ 4 
1.2 
Schema ............................................................................................................................................................................... 6 
2 
INTRODUCTION...................................................................................................................................................................... 7 
2.1 
Abbreviations and Terms: ........................................................................................................................................ 7 
2.2 
Background and Clinical Rationale for Data Review..................................................................................... 8 
3 
STUDY OBJECTIVES .............................................................................................................................................................. 8 
4 
STUDY DESIGN ........................................................................................................................................................................ 8 
4.1 
Overall Design ................................................................................................................................................................ 8 
4.2 
Study Structure .............................................................................................................................................................. 8 
4.3 
Duration ............................................................................................................................................................................ 9 
4.4 
Study Questionnaires/Assessment ....................................................................................................................... 9 
4.5 
Visits & Procedures ...................................................................................................................................................... 9 
5 
STUDY POPULATION CHARACTERISTICS .................................................................................................................. 9 
5.1 
Number of Subjects ...................................................................................................................................................... 9 
5.2 
Study Population Characteristics ....................................................................................................................... 10 
5.3 
Inclusion Criteria ....................................................................................................................................................... 10 
5.4 
Exclusion Criteria Procedures ............................................................................................................................. 10 
6 
Visits & Procedures ............................................................................................................................................................ 10 
6.1 
Pre-screening & Visits.............................................................................................................................................. 10 
6.1.1 
Procedures for Final Study Entry ........................................................................................................... 11 
6.1.2 
Pre-operative Visits 11 
6.1.3 
Follow-up Visits 
11 
6.2 
Standard Operative Procedures .......................................................................................................................... 11 
6.3 
Research Related Procedures............................................................................................................................... 12 
6.4 
Medical Imaging (Standard of Care) .................................................................................................................. 12 
6.5 
Instructions for the Subjects ................................................................................................................................. 12 
6.6 
Unscheduled Visits .................................................................................................................................................... 12 
7 
STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL ................................................................................................................................. 12 
7.1 
Early Discontinuation of Subjects....................................................................................................................... 12 
8 
OUTCOME MEASURES AND SUMMARY OF METHODS OF DATA COLLECTION .................................... 13 
8.1 
Outcome Measures .................................................................................................................................................... 13 
8.1.1 
Primary Outcome Measure ........................................................................................................................ 13 
8.1.2 
Secondary Out come Measures ................................................................................................................ 13 
8.1.3 
Exploratory Measures .................................................................................................................................. 13 
8.2 
Safety Measures .......................................................................................................................................................... 14 
8.3 
Summary of Methods of Data Collection ......................................................................................................... 14 
9 
STATISTICAL PROCEDURES .......................................................................................................................................... 14 
9.1 
Populations for Analyses ........................................................................................................................................ 14 
9.2 
Collection and Derivation of Primary and Secondary Outcome Measures ...................................... 14 
9.2.1 
Primary Outcome Measures ...................................................................................................................... 15 
9.2.2 
Secondary Outcome Measures ................................................................................................................. 15 
9.2.3 
Exploratory Measures .................................................................................................................................. 15 
9.3 
Hypothesis and Methods of Analysis ................................................................................................................ 15 
9.3.1 
Primary Outcome Measure Analysis ..................................................................................................... 15 

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9.3.2 
Secondary Outcome Measure Analysis ................................................................................................ 15 
9.3.3 
Exploratory Measures Analysis ............................................................................................................... 16 
9.3.4 
Safety Analysis 
16 
9.4 
Subgroup Analysis ..................................................................................................................................................... 16 
9.5 
Exploratory Analyses ............................................................................................................................................... 16 
9.6 
Sample Size Calculation .......................................................................................................................................... 16 
9.7 
Interim Analyses ........................................................................................................................................................ 17 
9.8 
Protocol Deviations ................................................................................................................................................... 17 
10 
STUDY ADMINISTRATION PROCEDURES ............................................................................................................. 17 
10.1 
Subject Entry Procedures ................................................................................................................................. 17 
10.1.1 
Overview of Entry Procedures ................................................................................................................. 17 
10.1.2 
Informed Consent and Subject Privacy ................................................................................................ 17 
10.2 
Compliance with Protocol ................................................................................................................................ 18 
10.3 
Study Termination ............................................................................................................................................... 18 
11 
ADVERSE EVENTS ........................................................................................................................................................... 18 
11.1 
Definitions ............................................................................................................................................................... 19 
11.1.1 
Adverse Event 
19 
11.1.2 
Serious Adverse Event ................................................................................................................................. 20 
11.2 
Procedures for Reporting Adverse Events ............................................................................................... 20 
11.3 
Reporting an SAE ................................................................................................................................................. 20 
12 
ADMINISTRATIVE ISSUES ............................................................................................................................................ 20 
12.1 
Protection of Human Subjects ........................................................................................................................ 20 
12.1.1 
Compliance with Informed Consent Regulations ............................................................................ 21 
12.1.2 
Compliance with IRB Regulations .......................................................................................................... 21 
12.1.3 
Compliance with Good Clinical Practice .............................................................................................. 21 
12.2 
Subject Confidentiality and Privacy ............................................................................................................. 21 
12.3 
Documentation ...................................................................................................................................................... 21 
12.3.1 
Source Documents 21 
12.3.2 
Document Completion ................................................................................................................................. 22 
12.3.3 
Retention of Documentation ..................................................................................................................... 22 
13 
REFERENCES ...................................................................................................................................................................... 23 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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STATEMENT OF COMPLIANCE 
 
The trial will be conducted in accordance with International Conference on Harmonisation 
Good Clinical Practice (ICH GCP) and the applicable United States (US) Code of Federal 
Regulations (CFR). The Principal Investigator will assure that no deviation from, or changes 
to the protocol will take place without prior agreement from the sponsor and documented 
approval from the Institutional Review Board (IRB), except where necessary to eliminate an 
immediate hazard(s) to the trial participants. All personnel involved in the conduct of this 
study have completed Human Subjects Protection and ICH GCP Training. 
 
The protocol, informed consent form(s), recruitment materials, and all participant materials 
will be submitted to the IRB for review and approval.  Approval of both the protocol and the 
consent form must be obtained before any participant is enrolled.  Any amendment to the 
protocol will require review and approval by the IRB before the changes are implemented 
to the study.  All changes to the consent form will be IRB approved; a determination will be 
made regarding whether a new consent needs to be obtained from participants who 
provided consent, using a previously approved consent form. 
 
1 
PROTOCOL SUMMARY 
 
1.1 
SYNOPSIS 
 
Title of the Study: Use of Platelet Rich Plasma after Arthroscopic Debridement for 
Triangular Fibrocartilage Complex Tears 
 
Number of Subjects: 48 
 
Objective: The objective of this study is to determine if treatment with platelet rich 
plasma (PRP) after arthroscopic debridement of triangular fibrocartilage complex 
(TFCC) tears improves patient outcomes when compared to those who were not 
treated with PRP after arthroscopic debridement.  
 
Methodology: 48 subjects with TFCC tears will be randomized to treatment with 
PRP versus placebo (normal saline). Subjects and medical staff outside of the 
operating room will be blinded to treatment group throughout the study. Outcome 
measures will include pain scale scores, grip strength, wrist range of motion, 
Patient-rated Wrist Evaluation (PRWE) scores, and Modified Mayo Wrist scores.  
 
Visit Schedule: Pre-operative visit, post-operative visits at month 1, month 3, 
month 6 and year 1. 
 

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Diagnosis and Main Inclusion Criteria for Inclusion/Exclusion:  Subjects with 
TFCC tears. 
 
Inclusion Criteria: 
• Male or Female >18 years of age 
• TFCC tear requiring surgical intervention 
• Be willing to undergo arthroscopic debridement and injection with PRP 
• Be in good health other than the TFCC tear 
• Have realistic expectations of surgical results 
• Understand and be willing to follow all aspects of the study protocol and 
have signed and dated the IRB-approved Informed Consent Form and the 
Authorization for Use and Release of Health and Research Study Information 
(HIPAA) form prior to any study-related procedures being performed 
 
Exclusion Criteria: To be eligible for enrollment, the subject must not: 
• Have collagen-vascular, connective tissue, or bleeding disorders  
• Be a smoker or have smoked in last 2 months  
• Have any disease, including uncontrolled diabetes, which is clinically known 
to impact wound healing ability  
• Have regional sympathetic dystrophy  
• Be pregnant, lactating or expecting to be within the next 24 months  
• Currently have an alcohol/substance abuse problem or have had a relapse 
within one year to screening visit 
• Have an abscess or infection at the time of surgery 
• Have a condition or be in a situation that, in the Investigator’s opinion, may 
put the subject at significant risk, may confound the study results, or may 
interfere significantly with the subject’s participation in the study 
 
Duration of the Study: Subjects will be followed for 12 months post arthroscopic 
debridement. 
 
Criteria for Evaluation: The primary outcome measure is the difference in 
improvement between preoperative and post-operative outcomes as measured by 
pain scale scores, grip strength, wrist range of motion, Patient-rated Wrist 
Evaluation (PRWE) scores, and Modified Mayo Wrist scores between patients 
treated with PRP and patients not treated with PRP after arthroscopic debridement. 
Pain scale scores, grip strength, wrist range of motion, PRWE scores, and the 
Modified Mayo Wrist Score will be measured at the pre-operative visit, and post-
operatively at month 1, month 3, month 6, and year 1.  
 
Statistical Methods: 
 
A sample size of 48 subjects (24 in the treatment group and 24 in the control group) 
will provide sufficient information to produce descriptive summaries of study 
outcome endpoints and to perform exploratory analyses. 

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The purpose of this study is to explore surgical outcomes after treatment with 
platelet rich plasma (PRP) in patients undergoing arthroscopic debridement for 
triangular fibrocartilage complex (TFCC) tears. We hypothesize that use of PRP after 
arthroscopic debridement will result in a clinically significant reduction in pain and 
improved functional outcomes compared to arthroscopic debridement alone, as 
measured by pain scale scores, grip strength, wrist range of motion, Patient-rated 
Wrist Evaluation (PRWE) scores, and the Modified Mayo Wrist Score. 
 
Schedule of Visits and Procedures: As depicted in Section 1.2. 
 
1.2 
SCHEMA 
 

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2 
INTRODUCTION 
 
2.1 
ABBREVIATIONS AND TERMS:  
 
PRP Platelet Rich Plasma 
TFCC Triangular Fibrocartilage Complex 
PRWE Patient-rated Wrist Evaluation  
 

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2.2 
BACKGROUND AND CLINICAL RATIONALE FOR DATA REVIEW 
 
Tears of the triangular fibrocartilage complex (TFCC) often result in ulnar sided 
wrist pain, decreased grip strength, and functional impairment1. Treatment options 
include conservative management with immobilization, open repair, and 
arthroscopic repair versus debridement with or without ulnar shortening2. The 
reported success rates after treatment, regardless of technique, are mixed.2,3 
indicating the need for new treatment modalities.  
 
New studies have emerged that support the use of platelet rich plasma (PRP) in the 
treatment of cartilage injuries and joint inflammation4,5,6. Randomized controlled 
trials demonstrate that the use of PRP in patients with hip and knee osteoarthritis 
decreases pain and improves function5. A pilot study by Loibl et al. showed similar 
results in basilar joint arthritis7. Molecular studies reveal that PRP significantly 
increases the proliferation of chondrocytes, anabolic factors (TGF-B1) and 
antiinflammatory cytokines (IL-4, IL-10, IL-13) while decreasing inflammatory 
enzymes (COX-2) and proteinases (MMP3, MMP13, ADAMTS-5, IL-6)4. As such, PRP 
may be beneficial in the treatment of patient’s with TFCC tears.  
 
3 
STUDY OBJECTIVES 
 
The objective of this study is to compare outcomes and functionality measures of 
subjects treated with platelet rich plasma (PRP) after arthroscopic debridement of 
triangular fibrocartilage complex (TFCC) tears to subjects treated with arthroscopic 
debridement alone.  
 
4 
STUDY DESIGN 
 
4.1 
OVERALL DESIGN 
 
Forty-eight (48) subjects with TFCC tears will be randomized to treatment with PRP 
versus placebo (normal saline). Subjects and medical staff outside of the operating 
room will be blinded to treatment group throughout the duration of the study. 
Outcome measures will include pain scale scores, grip strength, wrist range of 
motion, Patient-rated Wrist Evaluation (PRWE) scores, and Modified Mayo Wrist 
scores.  
 
4.2 
STUDY STRUCTURE 
 

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This is a randomized controlled trial, blinded to the subjects and medical support 
staff. 
 
4.3 
DURATION 
 
Subjects will be followed for 12 months post arthroscopic debridement. Their 
postoperative pain scale scores, grip strength, wrist range of motion, Patient-rated 
Wrist Evaluation (PRWE) scores, and Modified Mayo Wrist scores (measured at 
month 1, month 3, month 6, and year 1 postoperatively) will be compared to their 
preoperative scores. And the difference in improvement of the outcomes will be 
compared between treatment and control subjects. Study visits will coincide with 
standard clinical course visits including: pre-operative visits and follow-up visits at 
month 1, month 3, month 6 and year 1 post-operatively. 
  
 
4.4 
STUDY QUESTIONNAIRES/ASSESSMENT 
 
The patients of Dr. Kulber eligible to participate in the study will proceed with 
outcomes data collection once study consents have been signed and the patient has 
been enrolled in the study. 
 
4.5 
VISITS & PROCEDURES 
 
Enrolled subjects will undergo baseline questionnaires/assessments and baseline 
imaging during their pre-operative visit. Once arthroscopic debridement is 
complete, patients will be randomized intraoperatively to treatment with PRP 
versus placebo (normal saline). Subjects and medical staff outside of the operating 
room will be blinded to treatment group throughout the study. 
Questionnaires/assessments will then be administered and performed at month 1, 
month 3, month 6 and year 1 post-operative visits. Follow-up imaging will be 
performed at 6 month post-operative visit.  
 
5 
STUDY POPULATION CHARACTERISTICS 
 
5.1 
NUMBER OF SUBJECTS 
 
Forty-eight (48) subjects undergoing arthroscopic debridement for TFCC tears will 
be randomized intraoperatively to treatment with PRP (24 subjects) versus 
treatment with normal saline (24 subjects). 
 

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5.2 
STUDY POPULATION CHARACTERISTICS 
 
Subjects who meet the inclusion/exclusion criteria detailed below will be enrolled 
into the study. 
 
5.3 
INCLUSION CRITERIA 
 
• Male or Female >18 years of age 
• TFCC tear requiring surgical intervention 
• Be willing to undergo arthroscopic debridement and injection with PRP 
• Be in good health other than the TFCC tear 
• Have realistic expectations of surgical results 
• Understand and be willing to follow all aspects of the study protocol and 
have signed and dated the IRB-approved Informed Consent Form and the 
Authorization for Use and Release of Health and Research Study Information 
(HIPAA) form prior to any study-related procedures being performed 
 
5.4 
EXCLUSION CRITERIA PROCEDURES 
 
• Have collagen-vascular, connective tissue, or bleeding disorders  
• Be a smoker or have smoked in last 2 months  
• Have any disease, including uncontrolled diabetes, which is clinically known 
to impact wound healing ability  
• Have regional sympathetic dystrophy  
• Be pregnant, lactating or expecting to be within the next 24 months  
• Currently have an alcohol/substance abuse problem or have had a relapse 
within one year to screening visit 
• Have an abscess or infection at the time of surgery 
• Have a condition or be in a situation that, in the Investigator’s opinion, may 
put the subject at significant risk, may confound the study results, or may 
interfere significantly with the subject’s participation in the study 
 
 
6 
VISITS & PROCEDURES 
 
6.1 
PRE-SCREENING & VISITS 
 
The physician’s appointment calendar will be pre-screened of potential study 
candidates who would be eligible for arthroscopic debridement. No study related 
data will be collected/administered until patient has signed consent and HIPAA. 

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6.1.1 PROCEDURES FOR FINAL STUDY ENTRY 
 
A subject is considered “enrolled” when he/she has signed the IRB-approved 
consent form and HIPAA authorization in the presence of the Investigator, who will 
then collect and record the subject’s demographic information and medical history. 
 
6.1.2 PRE-OPERATIVE VISITS 
 
The subject will be screened in accordance with the inclusion/exclusion criteria and 
medical history collected. Pre-operative visual pain analogue score measurements, 
grip strength and wrist range of motion measurements, and Patient-rated Wrist 
Evaluation (PRWE) scores and Modified Mayo Wrist scores will be collected. Subject 
health information (e.g., demographics, general health), physical examination, 
medical photography, and hand imaging (see section 6.2) will be performed at 
screening. 
 
6.1.3 FOLLOW-UP VISITS 
 
Subjects will be required to attend post-operative visits at month 1, month 3, month 
6 and at year 1. Review of medical records, physical examination, and medical 
photography will be conducted at all post-operative visits. At month 1, month 3, 
month 6, and year 1 visual pain analogue score measurements, grip strength and 
wrist range of motion measurements, and Patient-rated Wrist Evaluation (PRWE) 
scores and Modified Mayo Wrist scores will be collected. Medical imaging (Section 
6.2) will be performed at month 6 post-operatively. 
 
6.2 
STANDARD OPERATIVE PROCEDURES 
 
Standard Imaging: PA, lateral, and oblique X-ray views of the wrist and MR 
Arthrogram will be obtained pre-operatively and 6 months post-operatively. 
Medical photographs of the hand and wrist will be taken at each visit and on the day 
of the procedure. 
 
Standard Surgical Procedure: The affected wrist is placed in a traction tower and 
arthroscopy is performed in standard fashion. A blunt trocar is placed through the 
3/4 portal and a probe is used through the 4/5 portal.  The wrist is then inspected 
for evidence of injury including the central and peripheral portions of the TFCC. An 
ArthroCare device is then inserted into the 4/5 portal, and the frayed TFCC is 
coblated.  

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6.3 
RESEARCH RELATED PROCEDURES 
 
Research Related Procedures: Once the arthroscopic debridement is complete, the 
patient is randomized to receive wrist injections of normal saline (placebo) or PRP 
(treatment group). The PRP is then obtained from patients assigned to the 
treatment arm (~9 cc of venous blood) and processed using the CASCADE 
Autologous Platelet System, a product made commercially available by the 
Musculoskeletal Transplant Foundation (MTF). Once processed, the PRP is injected 
into the debrided wrist.  
 
 
6.4 
MEDICAL IMAGING (STANDARD OF CARE) 
  
A copy of any medical imaging results (e.g., hand radiology) collected during the 
study duration will be included in the study file. Imaging of the hand will consist of 3 
X-ray views including PA, lateral and oblique views and an MR Arthrogram. Imaging 
will be completed pre-operatively and post-operatively at month 6. 
 
6.5 
INSTRUCTIONS FOR THE SUBJECTS 
 
There are no special instructions for the subjects beyond those typically provided 
for hand surgery and in the informed consent. Subjects will be asked to complete 
research related questionnaires and assessments as indicated in section 6.1.3. 
 
6.6 
UNSCHEDULED VISITS 
 
Each time the subject returns to the study site the Investigator will solicit and 
record information about any concurrent procedures or AEs as applicable though 
not anticipated. 
 
7 
STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL 
 
7.1 
EARLY DISCONTINUATION OF SUBJECTS 
 
Each subject reserves the right to withdraw from the study at any time without 
jeopardy to her future medical care. All follow-up assessments and procedures 

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should be performed at the final study visit. For any subject who discontinues from 
the study, the date and reason for discontinuation will be recorded. 
 
If a subject fails to return for one or more scheduled study visits, the Investigator 
will attempt to contact the subject to determine and document the reason the 
subject has failed to return and to encourage compliance with the study visit 
schedule. 
 
A subject may be discontinued from the study for the following reasons: 
• Subject did not undergo arthroscopic debridement as it was deemed not 
warranted by the Investigator 
• Since enrollment in the study, subject has had alternative treatment that 
would otherwise affect the study questionnaire/outcomes data 
• Subject does not complete scheduled follow-up visits per protocol 
• Subject has died 
 
8 
OUTCOME MEASURES AND SUMMARY OF METHODS OF DATA 
COLLECTION 
 
8.1 
OUTCOME MEASURES 
8.1.1 PRIMARY OUTCOME MEASURE 
 
The primary outcome measure is the difference in improvement between 
preoperative and post-operative pain scale scores, grip strength, wrist range of 
motion, Patient-rated Wrist Evaluation (PRWE) scores, and Modified Mayo Wrist 
scores between patients treated with PRP and patients not treated with PRP after 
arthroscopic debridement. 
 
8.1.2 SECONDARY OUT COME MEASURES 
 
Not applicable 
 
8.1.3 EXPLORATORY MEASURES 
 
• Pain scale score assessment 
• Grip strength 
• Wrist range of motion assessed by Investigator 
• PRWE score assessment 
• Modified Mayo Wrist Score assessment 

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8.2 
SAFETY MEASURES 
 
The incidence and severity of AEs related to the study will be captured. 
Investigators will inquire about the occurrence of any AEs at all study visits and 
unscheduled visits. Subjects will also be asked to self- report AEs throughout the 
duration of the study. Adverse events will be recorded. 
 
8.3 
SUMMARY OF METHODS OF DATA COLLECTION 
 
Paper documents will be used to collect standardized assessments for PRWE scores, 
Modified Mayo Wrist scores, and pain assessment. Study-specific information, such 
as Investigator reviews and assessments will be recorded directly in the subject’s 
medical record. 
 
Grip strength and wrist range of motion will be recorded by the Investigator in the 
subjects’ medical record. 
 
9 
STATISTICAL PROCEDURES 
 
Every attempt will be made to collect complete data and limit the occurrence of 
missing data. Due to the descriptive nature of all analyses, no imputation of missing 
data will be performed. Descriptive summaries will be based on all observations 
available within each of the relevant analysis populations.  
 
Descriptive statistics will be presented for key outcome measures. 
 
9.1 
POPULATIONS FOR ANALYSES 
 
All subjects will be included in the full analysis population. The per protocol 
population is defined as subjects who have not had any major protocol deviations 
throughout the study (Section 9.8) and will be analyzed as the primary study group. 
Other subgroups may be analyzed as detailed in the subgroup analyses section. 
Subjects that have been discontinued will be excluded from data analysis. 
 
9.2 
COLLECTION AND DERIVATION OF PRIMARY AND SECONDARY OUTCOME 
MEASURES 
 

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9.2.1 PRIMARY OUTCOME MEASURES 
 
The primary outcome measure is the difference in improvement between 
preoperative and post-operative pain scale scores, grip strength, wrist range of 
motion, Patient-rated Wrist Evaluation (PRWE) scores, and Modified Mayo Wrist 
scores between patients treated with PRP and patients not treated with PRP after 
arthroscopic debridement. 
 
9.2.2 SECONDARY OUTCOME MEASURES 
 
Not applicable 
 
9.2.3 EXPLORATORY MEASURES 
All exploratory variables will be analyzed as reported, without further derivation, 
except for the calculation of change from baseline, or change from prior time-points. 
 
9.3 
HYPOTHESIS AND METHODS OF ANALYSIS 
 
We hypothesize that use of PRP after arthroscopic debridement will result in 
greater pain reduction and improved functional outcomes when compared to 
arthroscopic debridement alone, as measured by pain scale scores, grip strength, 
wrist range of motion, Patient-rated Wrist Evaluation (PRWE) scores, and the 
Modified Mayo Wrist Score. 
 
9.3.1 PRIMARY OUTCOME MEASURE ANALYSIS 
 
The primary outcome measure is the difference in improvement between 
preoperative and post-operative pain scale scores, grip strength, wrist range of 
motion, Patient-rated Wrist Evaluation (PRWE) scores, and Modified Mayo Wrist 
scores between patients treated with PRP and patients not treated with PRP after 
arthroscopic debridement. 
 
Preoperative and postoperative outcome measures will be analyzed using 
descriptive statistics, including n, mean, standard deviation, median, minimum, 
maximum, and skewness.  
 
9.3.2 SECONDARY OUTCOME MEASURE ANALYSIS 
 
Not applicable. 

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9.3.3 EXPLORATORY MEASURES ANALYSIS 
 
All exploratory variables will be summarized with descriptive statistics appropriate 
to the scale of measurement for each variable. 
 
9.3.4 SAFETY ANALYSIS 
 
Safety analyses will include the incidence and severity of adverse events observed 
over the study assessment period. These will be tabulated and presented overall 
and by relatedness, severity, and preferred term. 
 
9.4 
SUBGROUP ANALYSIS 
 
Subgroup analyses will be performed to explore their relationship to key study 
outcomes. 
 
9.5 
EXPLORATORY ANALYSES 
 
The difference in preoperative versus postoperative outcomes within groups 
(treatment versus placebo) will be tested for significance using paired t-tests. The 
significance of differences in preoperative versus postoperative outcomes between 
groups (treatment and placebo group) will be analyzed using 2-sample t-tests.  
Additional analyses of possible relationships between outcomes may also be 
performed using appropriate inferential tests. 
 
9.6 
SAMPLE SIZE CALCULATION 
 
The trial will be powered to detect a difference in post-treatment PRWE scores 
between groups of 15, deemed to be clinically significant by the investigators. The 
standard deviations for PRWE scores previously published after treatment for TFCC 
tears ranges from 6.6 to 20.5. To detect a mean difference in post-treatment PRWE 
score of 15 points (SD = 18) with a two-sided significance level of 5% and power of 
80% with equal allocation to two arms would require 24 patients in each arm of the 
trial. 
 
Subjects will be assessed per standard of care of their clinical requirement and 
qualification for surgery and upon subject’s decision to participate in the study.  The 
difference in preoperative and postoperative outcomes will be analyzed to 

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determine which group has the most improvement based on the following 
outcomes: pain scale scores, wrist range of motion, PRWE scores, and Modified 
Mayo Wrist scores.  
 
9.7 
INTERIM ANALYSES 
 
Not applicable. 
 
9.8 
PROTOCOL DEVIATIONS 
 
Protocol deviations may include: 
• Deviations from the protocol, contrary to protocol specifications (i.e., 
deviations from the protocol, eligibility, visit windows, etc.). 
• Deviations affecting the endpoint outcome not previously specified in the 
protocol (i.e., deviation that had not been previously considered in the 
protocol or eligibility criteria, however having a clear impact on the primary 
outcome measure)  
All protocol deviations will be reviewed and categorized as major (i.e., those that 
affect measurement or interpretation of the primary endpoint) or minor (those not 
affecting the primary endpoint). 
 
10 STUDY ADMINISTRATION PROCEDURES 
 
10.1 SUBJECT ENTRY PROCEDURES 
 
10.1.1 OVERVIEW OF ENTRY PROCEDURES 
 
Prospective subjects as defined by the criteria in Section 5.3 and 5.4 
(inclusion/exclusion criteria) will be considered for entry into this study. 
 
10.1.2 INFORMED CONSENT AND SUBJECT PRIVACY 
 
The purpose, procedures, risks, benefits, and alternatives to study participation will 
be discussed with each potential subject. Prior to any study-related procedures or 
change in treatment, subjects wishing to participate must give their written 
informed consent (IC). The subject must also give Authorization for Use and Release 
of Health and Research Study Information (HIPAA) and other written 
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requirements (where applicable) prior to any study-related 
assessments/questionnaires. Subjects will be consented to provide a copy of all 
medical imaging (e.g. radiology) collected as standard-of-care or research during the 
study duration for inclusion in the study file. The Investigator will conduct the IC 
discussion and will document in the subject’s medical records the process for 
acquiring IC and the subject’s agreement or refusal to notify her primary care 
physician about the study. The subject should personally sign and date the IC form. 
The Investigator will retain the original copy of the signed IC form, and the subject 
will also receive a copy. Upon signing the IC form, the subject will receive a subject 
number that will be used on all documentation for the subject throughout the study. 
Subject numbers should be assigned in ascending order, and numbers should not be 
omitted or reused. The subject number is a unique identification for each subject. 
 
10.2 COMPLIANCE WITH PROTOCOL 
 
All eligible subjects to be treated by Dr. David Kulber will be counseled on the 
procedure as well as the possibility of treatment with PRP, as dictated by their 
randomization to treatment with PRP versus normal saline. Eligible patients 
enrolled into each treatment arm will be asked to complete research questionnaires 
and post-operative assessments as indicated within the schedule or procedures. 
The Investigator is responsible for the overall conduct of the study and compliance 
with the protocol including subject recruitment, IC, screening evaluations, eligibility, 
assessment/procedure, study evaluations, and any study-related medical care. The 
Investigator may choose to delegate some of these tasks to suitably trained research 
staff personnel, but the Investigator is ultimately responsible for these activities. 
 
10.3 STUDY TERMINATION 
 
If conditions arise during the study that indicate that the study should be 
terminated, the Investigator, Monitor, IRB, and/or regulatory agencies will discuss 
the situation and take appropriate action after consultation. Conditions that may 
warrant termination of the study or site include, but are not limited to: 
• Discovery of an unexpected, serious, or unacceptable risk to subjects enrolled 
in the study 
• Failure of the Investigator to comply with pertinent national or state 
regulations, IRBimposed conditions, or protocol requirements 
• Submission of knowingly false information from the Investigator to IRB, or 
any regulatory agency 
 
11 ADVERSE EVENTS 
 

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Throughout the course of the study, AEs will be monitored and reported on an AE 
CRF, including seriousness, severity, relationship to device, and action taken. If AEs 
occur, the first concern will be the safety of the study participants. The Investigator 
and the research staff will monitor each subject closely, and record any 
complications that may arise, though not anticipated. Study clinician will use 
his/her medical judgment to do whatever is necessary to help treat the problem. 
Potential risks and/or side effects include:  
 
Foreseeable Risk  
• Discomfort  
• Pain  
• Redness  
• Swelling  
• Local or systemic infection  
• Dehiscence and/or necrosis due to poor revascularization  
• Specific or nonspecific immune response to some component of PRP 
treatment 
 
11.1 DEFINITIONS 
 
11.1.1 ADVERSE EVENT 
 
An adverse event (AE) is any untoward medical occurrence in a subject that does 
not necessarily have a causal relationship with the treatment. An adverse event can 
therefore be any unfavorable and unintended sign (including an abnormal 
laboratory finding), symptom, or temporal disease, whether or not related to the 
study assessment(s)/questionnaire(s). 
 
Pre-existing disease or symptoms thereof prior to study enrollment are not 
considered AEs unless the condition recurs after the subject has recovered from the 
pre-existing condition, or the condition worsens in intensity or frequency during the 
study. Normal post-operative sequelae will not be recorded as adverse events. 
Specifically, normal post-operative pain, swelling, tenderness, loss of skin sensation 
and ecchymosis within the first two weeks postoperative, requiring normal levels of 
medication will not be recorded; all abnormal intensity or duration will be recorded 
and considered an adverse event as well as following the two-week post-operative 
period. 
Adverse events will be monitored throughout the study. At each post-baseline visit, 
the Investigator will begin querying for adverse events by asking each subject a 
general, nondirected question such as “Have you had any changes to your condition 
since your last visit?” Previous adverse events and changes in therapy/concomitant 
medications should be updated. Directed questioning and examination will then be 
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11.1.2 SERIOUS ADVERSE EVENT 
 
A serious adverse event (SAE) is defined as any untoward medical occurrence that 
at any dose:  
• results in death 
• is life-threatening  
• requires inpatient hospitalization or prolongation of existing hospitalization 
• results in persistent or significant disability/incapacity 
• is a congenital anomaly/birth defect  
 
Important medical events that may not result in death, be life-threatening, or 
require hospitalization may be considered an SAE when, based upon appropriate 
medical judgment, they may jeopardize the subject or subject and may require 
medical or surgical intervention to prevent one of the outcomes listed in this 
definition. 
 
11.2 PROCEDURES FOR REPORTING ADVERSE EVENTS 
 
Adverse events should be reported to governing IRB per governing IRB reporting 
requirements. 
 
11.3 REPORTING AN SAE 
 
Any SAE occurring during the study period and for at least 30 days after the last 
study visit should be immediately reported (within 24 hours) and recorded. The 
Investigator should supply the Sponsor and the IRB with any additional requested 
information (e.g., hospital discharge summary, autopsy report, pathology report, 
operative report, terminal medical report, etc.). 
 
12 ADMINISTRATIVE ISSUES 
 
This protocol is to be conducted in accordance with the applicable Good Clinical 
Practice regulations and guidelines, e.g., the International Conference on 
Harmonisation (ICH) Guideline on Good Clinical Practice (GCP). 
 
12.1 PROTECTION OF HUMAN SUBJECTS 
 

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12.1.1 COMPLIANCE WITH INFORMED CONSENT REGULATIONS 
 
Written informed consent is to be obtained from each subject prior to enrollment 
into the study, and/or from the subject’s legally authorized representative. The 
process for obtaining informed consent must also be documented in the subject’s 
medical record. 
 
 
12.1.2 COMPLIANCE WITH IRB REGULATIONS 
 
This study is to be conducted in accordance with applicable IRB regulations. The 
Investigator must obtain approval from a properly constituted IRB prior to initiating 
the study and re-approval or review at least annually. 
 
12.1.3 COMPLIANCE WITH GOOD CLINICAL PRACTICE 
 
This protocol is to be conducted in accordance with the applicable GCP regulations 
and guidelines. 
 
12.2 SUBJECT CONFIDENTIALITY AND PRIVACY 
 
A report of the results of this study may be published, but the subject’s name will 
not be disclosed in these documents. The subject’s name may be disclosed to the 
study Sponsor, the governing health authorities or the Food and Drug 
Administration (FDA), if they inspect the study records. Appropriate precautions 
will be taken to maintain confidentiality of medical records and personal 
information.  
 
Written Authorization and other documentation in accordance with the relevant 
country and local privacy requirements (where applicable) are to be obtained from 
each subject prior to enrollment into the study, and/or from the subject’s legally 
authorized representative in accordance with the applicable privacy requirements 
(e.g., HIPAA). 
 
12.3 DOCUMENTATION 
 
12.3.1 SOURCE DOCUMENTS 
 

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Source documents may include a subject’s original (or certified copy) medical 
records, hospital charts, clinic charts, the Investigator’s subject study files, as well as 
the results of diagnostic tests such as X-rays and MR Arthrograms. 
 
The following information should be entered into the subject’s medical record: 
• Subject’s name 
• Subject’s contact information 
• Date that the subject entered the study and subject number 
• The study title and/or the protocol number 
• A statement that informed consent was obtained and the process for 
obtaining consent, including the date. A statement that HIPAA Authorization 
or other country and local subject privacy required documentation for this 
study has been obtained, including the date.  
• Dates of all subject visits 
• All concomitant procedures 
• Subject standardized radiology as specified in the outcome metrics 
• Occurrence, treatment for, and status of any adverse events 
• Date the subject exited the study, and a notation as to whether the subject 
completed the study or reason for discontinuation. 
• Protocol deviations, as applicable 
 
12.3.2 DOCUMENT COMPLETION 
 
Source documents must meet the criteria to be acceptable in assessing the quality 
and integrity of the data during inspection or review of that data: attributable, 
legible, contemporaneous, original, accurate and available upon request. The 
Investigator is responsible for ensuring that data is properly recorded on each 
subject’s record. 
 
12.3.3 RETENTION OF DOCUMENTATION 
 
All study related correspondence, subject records, consent forms, subject privacy 
documentation, records of the distribution and use of device, and copies of 
documentation should be maintained on file. Documents should be retained and 
available for audit by regulatory authorities until at least 2 years after the latest 
among the following scenarios: completion or termination of the study, the 
last approval of a marketing application, no pending or contemplated marketing 
applications, or formal discontinuation of clinical development of the device. These 
documents should be retained for a longer period, however, if mandated by the 
applicable regulatory requirements, by conditions imposed by the IRB. 
 

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13 REFERENCES 
 
1. Doarn MC, Wysocki RW. Acute TFCC Injury. Operative Techniques in Sports 
Medicine. 2016 Jun 30;24(2):123-5.  
2. Ahn AK, Chang D, Plate AM. Triangular fibrocartilage complex tears. Joint 
Diseases. 2006 Dec 1;64(3):114-9.  
3. Saito T, Malay S, Chung KC. A systematic review of outcomes after 
arthroscopic débridement for triangular fibrocartilage complex tear. Plastic 
and reconstructive surgery. 2017 Nov 1;140(5):697e-708e.  
4. Moussa M, Lajeunesse D, Hilal G, El Atat O, Haykal G, Serhal R, Chalhoub A, 
Khalil C, Alaaeddine N. Platelet rich plasma (PRP) induces chondroprotection 
via increasing autophagy, anti-inflammatory markers, and decreasing 
apoptosis in human osteoarthritic cartilage. Experimental cell research. 2017 
Mar 1;352(1):146-56.  
5. Laver L, Marom N, Dnyanesh L, Mei-Dan O, Espregueira-Mendes J, Gobbi A. 
PRP for Degenerative Cartilage Disease: A Systematic Review of Clinical 
Studies. Cartilage. 2016 Sep 1:1947603516670709.  
6. Hsu WK, Mishra A, Rodeo SR, Fu F, Terry MA, Randelli P, Canale TS, Kelly FB. 
Platelet-rich plasma in orthopaedic applications: Evidence-based 
recommendations for treatment. Journal of the American Academy of 
Orthopaedic Surgeons. 2013 Dec 1;21(12):739-48.  
7. Loibl M, Lang S, Dendl LM, Nerlich M, Angele P, Gehmert S, Huber M. 
Leukocyte-reduced platelet-rich plasma treatment o