Dorsal Wrist Ganglia; Aspiration Alone vs Aspiration and Injection of Platelet Rich Plasma
Phase: NA
Conditions: Ganglion of Wrist
Sponsor: University of Aberdeen

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STUDY PROTOCOL 
 
Full Title: 
Dorsal Wrist Ganglia; Aspiration alone vs Aspiration and 
Injection of Platelet Rich Plasma  
Sponsor: 
NHS Grampian and The University of Aberdeen 
Sponsor Reference Number: 
 3-091-17 
Funder: 
Arthrex  
Chief Investigator: 
Mr David Lawrie  
REC Reference Number: 
17/WA/0425  
R&D Reference Number: 
205497/1153695/14/232  
 

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TABLE OF CONTENTS 
 
Protocol Approval 
3 
List of Abbreviations 
4 
Summary 
5 
1. Introduction 
6 
2. Study Objectives 
8 
3. Study Design 
9 
4. Study Population 
10 
5. Participant selection and enrolment  
10 
6. Randomisation and blinding 
11 
7. Study and Safety assessments 
12 
8. Data collection and management 
13 
9. Lab and Sample Analysis 
14 
10. Statistics and Data Analysis 
14 
11. Trial/Study Management and Oversight Arrangements 
15 
12. Inspection of Records 
15 
13. Good Clinical Practice 
16 
14. Study Conduct Responsibilities 
17 
15. Reporting, Publications and Notification of Results 
18 
16. Funding and Equipment 
19 
Appendix 1. References 
20 
Appendix 2. Patient Reported Measure (PEMS) 
21 
Appendix 3. Processing Procedure for PRP 
23 
Appendix 4. Study Flow Diagram 
24 
Appendix 5. Attached Documents 
25 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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PROTOCOL APPROVAL 
Dorsal Wrist Ganglia; Aspiration alone vs Aspiration and Injection of Platelet Rich Plasma 
Signatures 
 
The protocol has been reviewed by: 
 
Mr David Lawrie, Orthopaedic Consultant – Chief Investigator 
 
Signature:                  
        Date:               25/09/2017 
 
Mr Patrick Ashcroft, Orthopaedic Consultant – Internal Peer Review for study 
Mr Scott Barker, Orthopaedic Consultant – External Peer Review 
Mrs Carol Carnegie, Research Nurse - External Peer Review 
Miss Katharine Hamlin, Orthopaedic Registrar – Principle Investigator and Author 
 
 
Research Team Arthrex - Funder 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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LIST OF ABBREVIATIONS 
 
 
GCP 
Good Clinical Practice 
ISF 
Investigator Site File 
TMF/SMF 
Trial/Study Master File 
SOP 
Standard Operating Procedure 
CRF 
Case Report Form 
CNORIS 
Clinical Negligence and Other Risks Scheme 
PRP 
Platelet Rich Plasma 
DWG 
Dorsal Wrist Ganglia/Ganglion 
US 
Ultrasound 
PEM 
Patient Evaluated Measure Score 
DFML 
Mr David Lawrie (Chief Investigator) 
KH 
Miss Katharine Hamlin 
RN 
Research Nurse 
OR 
Orthopaedic Registrar 
SOS 
Surgical Outcomes System 
CM 
Miss Clare Miller 
 

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SUMMARY 
 
We propose to undertake a study where we examine the efficacy of Platelet Rich 
Plasma (PRP) to reduce recurrence in dorsal wrist ganglia (DWG).  PRP is produced by 
centrifugation or spinning of a sample of the patient’s blood, which separates out 
the different components.  DWG are cystic collections arising from the wrist joint.  
Most common treatment is aspiration or reassurance as they have a high recurrence 
rate with any current treatment. 
 
We will compare aspiration alone and aspiration with injection of PRP.  We plan to 
recruit a maximum of 200 patients. We will assess the efficacy by contacting the 
patients by email or telephone at 6 weeks and 12 months.  Adverse events will be 
screened for/ managed by a telephone call +/- review as necessary between 7 and 
14 days.  They will be asked to complete a questionnaire and a Patient Evaluated 
Measure score (PEMS).  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1.  
INTRODUCTION 
1.1.  
Background 
 
Ganglia are soft tissue tumours which consist of a cavity with a collagen wall 
and filled with mucin rich in hyaluronic acid, glucosamine, globulin and 
albumin1
.  The wall consists of collagen fibres arranged into sheets, with 
occasional mesenchymal cells.  The lining is largely acellular with scattered 
fibroblasts2.  The cavity communicates with the joint.  Although the aetiology is 
unclear, it is thought to arise from a rent in the capsule allowing escape of 
synovial fluid.  50% have underlying joint pathology on Arthroscopy3. 
The vast majority of ganglia present around the wrist, with 60-70% located on 
the dorsal aspect4.  The prevalence is men 25/100,000 and females 
43/1000005.  MRI studies have shown that they are present in 51% of the 
asymptomatic population and 19% of patients presenting with wrist pain6. 
They are the second commonest referral to a hand surgeon7.  The most 
common reasons people present with their DWR are: cosmesis (38%), fear of 
malignancy 28%, pain 26% and 8% reduced function or sensation8.   Pain has 
been reported to be present in 89% of ganglia but only 19% felt it was 
significant3.  They are readily detectable by Ultrasound and MRI but the 
diagnosis is usually clinical9-10. 
Many solutions have been sought for dorsal wrist ganglia, but each has been 
troubled by recurrence.  Non-surgical methods such as bursting it with firm 
pressure, simple aspiration +/- multiple puncture and aspiration plus steroid, 
hyaluronic acid or sclerosant all have similar rates of recurrence, but widely 
ranging between studies with rates from 18-93% reported and a 5% 
complication rate.  Similarly surgical excision including the whole tract, which 
can be performed open or arthroscopically,  is reported to have recurrence 
rates of 0-59% and up to 25% complication rate.  When this is considered in the 
light that 49% of ganglia spontaneously resolve it is clear the solution has not 
yet been found3. 
Platelet rich plasma has been shown useful in many conditions and further 
studies are underway from bone, soft tissue and skin grafting, to 
tendinopathies, nerve injuries and even hair regrowth,12,13.  It is defined as 
autologous plasma with a platelet count of 1,000,000 platelets/µl.   It contains 
seven native growth factors plus cell adhesion molecules contained within a 
normal clot11.  Platelet function includes increasing cell mitosis, increasing 
collagen production, recruitment of inflammatory cells, initiating angiogenesis, 
and inducing cell differentiation14. 

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Platelet rich plasma would be harvested from a sample of the patient’s blood 
at the same visit as the aspiration and undergo the double centrifugation 
technique.  Once activated the platelets  secrete 70% of their stored growth 
factors in 10 minutes and the evacuation is almost complete after hour. They 
then synthesize additional factors until they die after about 8 days11. 
Autologous material is inherently safe and acceptable to patients.  There is no 
risk of immune reaction or transmission of blood borne disease.  It is never 
been associated with increased, or decreased, infection rates or induction of 
malignancy15. 
No prior studies on the use of PRP to prevent dorsal wrist ganglia recurrence 
have been found. 
 
1.2.  
Rationale for Study 
 
We believe that by injecting platelet rich plasma into ganglia after aspiration  of 
the contents, the platelets would be activated by exposure to the collagen 
wall14 and adherent clot would form in the cavity.  It is plausible that the 
growth factors would cause differentiation of the mesenchymal cells within the 
walls and draw in inflammatory cells and thus from a relatively acellular 
position the means for healing have been provided.  If the walls became 
scarred together obliterating the space then recurrence would be reduced.  
Aspiration is commonly performed and we do not believe any additional risk is 
posed to the patient from injection of PRP.  Ganglia usually recur by 6 months 
so 1 year is adequate follow up. 
 
 

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2.  
STUDY OBJECTIVES 
2.1.  
Objectives 
2.1.1. Primary Objective 
To assess if injection with Platelet Rich Plasma prevents recurrence after 
aspiration of dorsal wrist ganglia compared to aspiration alone? 
  
2.1.2. Secondary Objectives 
Does aspiration of dorsal wrist ganglia with or without injection of Platelet Rich 
Plasma alter PEM Score after 6 weeks and 12 months? 
  
2.2.  
OUTCOMES 
2.2.1. Primary Outcome 
Presence or absence of ganglion recurrence as reported by the patient at 6 
weeks and 12 months. 
  
2.2.2. Secondary Outcomes 
Patient reported outcome measure - PEM score which includes patient 
reported assessments of: 
1. Stiffness 
2. Pain 
3. Cosmesis 
 
  
 
 

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3.  
STUDY DESIGN 
3.1.  
Study Description 
 
1. Patient selection 
All hand referrals vetted by Mr Lawrie or Miss Miller, those for 
dorsal wrist ganglia sent a letter of invitation and patient 
information.  Patients responding to the letter with interested given 
an appointment at a special trial clinic.   
Contact details will be provided to allow any issues to be clarified 
discussed before attendance at clinic if the patient desires. 
2. Assess eligibility/ enrolement in study – clinic visit 1 
a) All patients assessed by the chief investigator Mr David Lawrie (DFML)  
or Miss Katharine Hamlin (KH). 
b) Clinical assessment of presence of ganglion. 
c) Ensure not meeting exclusion criteria. 
d) If eligible and willing to complete study commitments discuss study and 
answer questions. 
e) Once we are happy the patient has understanding of the study and its 
risks then the patient will be asked if they wish to enrol or if they would 
like more time to consider. 
f) If they are willing to participate they will then be offered treatment in 
the same visit or a return visit 
3. Intervention – clinic visit 1 or 2 
a) Check understanding and continuing desire to participate in study if 2nd 
visit. 
b) Complete consent form. 
c) Patient fills out a PEM score and demographics collected on SOS. 
d) Randomisation. 
e) If in PRP group 15ml blood sample taken with Arthrex ACP double 
syringe and processed (see processing instructions in Appendix.9. 
f) Aspiration. 
g) If in PRP group - Injection of PRP (the same volume as aspirated). 
h) Pressure dressing with gauze, wool and crepe for 48 hours. 
4. Adverse event screening/ management 
Patients are offered two options at the treatment visit.   
1. Routine review at 10 – 14 days at the clinic  
  or 
2. Telephone review at 7 days by Miss Katharine Hamlin who will have 
performed the procedure.   
On telephone review if the patient is entirely happy that there are no concerns 

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then follow up will proceed by email or telephone as below. 
If any concerns are raised, or if the patient desires, a face to face review will be 
arranged ideally within 24 hours but no longer than 72 hours.  Recurrence or 
other outcomes will not be assessed at this time. 
5. SOS/ Email/ Telephone interview - 1 (6 weeks) 
a) Ganglion questionnaire 
b) PEM score 
c) Note any adverse events 
 
6. SOS/ Email /Telephone interview - 2  (12 months) 
a) Ganglion questionnaire 
b) PEM score 
c) Note any adverse events 

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3.2.  
Study Flowchart 
See Appendix 8. 
 
 
 
 
4.  
STUDY POPULATION 
4.1.  
Number of Participants 
 
We would like to recruit a maximum of 100 patients who have a solitary dorsal 
wrist ganglion to each treatment arm.  A total of 200 patients. 
 
4.2.  
Inclusion Criteria 
Solitary dorsal wrist ganglion. 
Over 16 years of age. 
 
4.3.  
Exclusion Criteria 
Underlying wrist or ipsilateral arm pathology. 
Unable to consent to treatment. 
Unable or unwilling to attend follow up visits. 
 
 
5.  
PARTICIPANT SELECTION AND ENROLMENT 
5.1.  
Identifying Participants 
Mr David Lawrie (DFML) or Miss Clare Miller (CM)  will vet all GP patient 
referrals for DWG.  Each patient will be sent a letter of invitation and patient 
information.  Patients will be asked to telephone DFML secretary for an 
appointment at a special trial clinic.  At the clinic patients will have a history 
and examination performed to confirm the presence of the ganglion clinically 
and  ensure no other pathology present.  The study will be discussed, any 
questions answered and assess willingness to participate. 
 
 
5.2.  
Consenting Participants 
To ensure that patients have adequate access to information and discussion 
prior to a potential ‘one-stop’ visit a letter will be sent to the patient prior to 
the clinic visit including the patient information.  The patient information 
leaflet contains contact information allowing potential participants to contact a 
team member prior to attendance if they wish to clarify any issues or ask 
questions.  On the day each patient will be seen by a member of the research 
team (Miss Katharine Hamlin) and eligibility assessed.  If eligible the study will 
be discussed and a further opportunity to ask questions.  Once we are happy 
the patient has understanding of the study and its risks then the patient will be 
asked if they wish to enrol or if they would like more time to consider.  If they 

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are willing to participate they will then be offered intervention in the same visit 
or a return visit and they will be able to choose.  Consent will be taken at the 
treatment visit if a second appointment is desired.  If they are uncertain they 
will be provided with contact details and asked to call for an appointment if 
they decide they would like to participate in the future.   
 
Mr David Lawrie (DFML) or Miss K Hamlin (KH) will consent all patients prior to 
intervention being performed visit and record this on a written consent form 
(see attached documents).  The form will be copied in triplicate for the patient, 
their medical notes and the trial file.  All researchers taking consent have under 
gone Good Clinical Practice Training and are familiar with the procedure and its 
risks.  The participants GP will be informed of the study with their consent. 
 
 
5.3.  
Screening for Eligibility 
Clinical screening for presence of ganglion. 
 
 
5.4.  
Ineligible and Non-Recruited Participants 
Ineligible and non-recruited patients will have only a standard GP clinic letter 
recorded.  No other data will be taken or stored. 
 
 
 
 

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6.  
RANDOMISATION AND BLINDING 
6.1.  
Randomisation Details 
Once consent and understanding have been checked the patients will be 
allocated to one of the two groups randomly. 
 
The study will be block randomized at a 1:1 ratio.  We will create a block 
randomization scheme utilizing http://www.randomization.com/.  All blocks 
will contain an increment of 10 subjects per group and there will be 20 blocks.   
 
The randomization scheme will be enclosed in envelopes with each individual 
envelope containing one procedure per the block randomization process (see 
Section 3 for details on study groups).   The exterior of the envelope will be 
marked with the study title and a number (1 through 200); however, the 
contents of the envelope will not be visible.   
 
The randomization will be performed by Miss Alexandra Haddon, who will also 
create the envelopes.  Her only other role will be ensuring compliance with the 
follow up schedule. 
 
For a particular subject, prior to the procedure, the investigator will select the 
next consecutive envelope and open the envelope to determine the procedure 
for the particular subject.  Miss Katharine Hamlin is the contact point for 
randomization.  The appropriate procedure will be performed, and the 
procedure along with the envelope number will be recorded in the study file. 
 
 
6.2.  
Blinding 
Blinding will not be performed to save the patients in aspiration alone group 
the unnecessary discomfort of blood sampling.  We feel this is justifiable as the 
return of the ganglion or not is a physical finding and not influenced by other 
factors.  The assessor and analyst will be blinded. 
 
 
6.3.  
Withdrawal Procedures 
A patient may withdraw from the trial at any time.  A withdrawal form will be 
completed and filed in the trial folder.  If the patient grants permission at the 
time of withdrawal data will be retained for inclusion in analysis as appropriate.  
Patients will be replaced if they have not completed either follow up time 
points. 
 
 

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7.  
STUDY AND SAFETY ASSESSMENTS 
No specific safety requirements are required PRP is already commonly used for 
injections and as a product generated from the patient’s own blood has an 
excellent safety profile.  Blood will be sampled, processed and re-injected by 
the same person in the same visit, with only one patient at a time receiving the 
intervention to ensure no mistakes regarding patient identity can be made. 
 
The sample is taken, processed and injected from the same specially designed 
syringe so that the internal contents maintain sterility.  This is routinely 
performed in the out-patient clinic setting rather than theatre, although every 
effort at sterility will be maintained with sterile dressing packs, gloves and 
dressings being used.  All the procedures will be performed by Miss Katharine 
Hamlin who has been trained in venepuncture and aspiration of ganglia via her 
role as orthopaedic registrar and has undertaken additional training from 
Nursing/ Medical Staff trained and practiced at processing the samples at the 
Orthopaedic Out-patient clinic. 
 
Adverse Events (AE) anticipated may include localised minor pain or swelling of 
short duration (24-72hrs), minor cellulitis requiring oral antibiotics treated by 
GP.   
 
The patients will be offered clinicial or telephone review (which may proceed 
to urgent clinical review if concerns to monitor for the presence of adverse 
events and to ensure they are recognised and treated promptly.  The patient 
information leaflet contains instructions on when and where to seek medical 
help if concerns at any time.  Patient reports will be requested at each follow 
up with space for recording on each CRF.  The patients will also be able to 
inform the study of AE on SOS.  Finally, the GP will be advised to inform Mr 
Lawrie of any study related patient contact with them.  Clinic follow up by Mr 
Lawrie or his registrar will be arranged as required.  As a new indication for PRP 
we plan to collate and report on all AE. 
 
Serious Adverse Events (SAE) such as hospitalisation for major cellulitis 
requiring IV antibiotics, abscess formation or septic arthritis requiring surgical 
management will be reported immediately to the sponsor.  These are 
anticipated to be rare events (<1%) in line with major infective complications 
from other Orthopaedic procedures. 
 
Upon recognition of any event an Adverse event an Adverse Event Form should 
be completed and placed in the study file.  The file will also contain an AE log. 
 
 

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8.  
DATA COLLECTION AND MANAGEMENT 
8.1.  
Data Collection 
Data will be collected as both electronic files and paper questionnaires and 
letters. Electronic files will be collected with the Surgical Outcomes System, a 
research registry run by Arthrex.  All data will be kept secure and confidential, 
see appendix 11.  Paper files will be kept in a locker filing cabinet in the Upper 
Limb Unit Secretaries office. 
 
All participants will be assigned a unique identifier for the duration of the 
study.  A separate log will be kept linking the ID number to the participant 
which will be kept and stored confidentially. 
 
Surgical outcome system is an online bespoke database containing the data as 
shown on the case report forms in Appendix 6 and 7.  Patients will be identified 
only by their unique study ID and demographic information (age at time of 
study and sex) will be entered.  Access is password protected on an individual 
basis.  The database is a Microsoft SQL Server database using transparent data 
encryption.  Plausibility data validation is in place, data is checked upon saving.  
There is a daily full back up of the data.  Data enquires will be handled by Miss 
Katharine Hamlin. 
 
SOS is hosted on servers operated exclusively for Arthrex by Amazon Web 
Services, Inc. (AWS). The data will be stored on an AWS Server in Germany. The 
data centre has multiple layers of operational and physical security to ensure 
the integrity and safety of the data. The data centre utilizes state-of-the-art 
electronic surveillance and multi-factor access control systems. The data centre 
is staffed 24 / 7 by trained security guards and access is authorized on a least 
privileged basis.  See also appendix 11.  An anonymised database will be stored 
on secure shared NHS Grampian drive, with access only to research team. 
 
Data files from SOS will be extracted onto NHS computers as password 
protected excel files will be stored on secure shared NHS Grampian drive, with 
access only to research team.   
 
 

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9.  
LABS AND SAMPLE ANALYSIS 
9.1.  
There is no laboratory requirement.  Blood samples will be processed by 
centrifuge (spinning) in the clinic to produce PRP with sterile technique.  No 
further analysis or storage will be undertaken.  Any remaining blood products 
will be safely disposed of in the clinic. 
 
10.  
STATISTICS AND DATA ANALYSIS 
10.1. 
Sample Size Calculation 
 
 
90 participants in each arm would give a 90% power to detect a change in 
recurrence rate of 25%.  We believe this is adequate as current recurrence 
rates are 59%.  This would need to be increased to 100 participants recruited 
per arm to allow for 10% drop out from follow-up. 
 
As the recurrent rate is so large recruiting 90 patients would detect up to a 25% 
difference in recurrence rate.  To ensure the trial is not extended beyond the 
point of answering our question we have also calculated numbers to allow for 
the trial to be closed early if we have sufficient data.    
 
62 participants completing follow-up in each arm would give 90% power to 
detect a change in recurrence rate of 30%. This would need to be increased to 
69 per arm to allow for 10% drop out from follow-up. 
 
46 participants completing follow-up in each arm would give 90% power to 
detect a change in recurrence rate of 35%. This would need to be increased to 
51 per arm to allow for 10% drop out from follow-up. 
 
Therefore we will undertake initial data analysis after 51 and 69 participants 
have completed their 6 week review and if the difference in the recurrence 
rate is more than 35% or 30% then we will conclude the trial, but all 
outstanding follow up will be completed and data included in final analysis. 
 
10.2. 
Proposed Analysis 
Statistical analysis will be performed to assess homogeneity of the study 
groups and efficacy of treatment.  The primary outcome will use chi-squared 
test (with or without continuity correction).  The secondary outcome will be 
assessed using independent T test if normally distributed or Mann-Whitney 
test if not.   
The difference between the two groups will be significant if the p values are 
less than 0.05. 
 
The analysis will be performed by Sarah Henrich who is a Clinical Specialist on 
the Arthrex Research team based in Germany. 
 

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10.3. 
Missing Data 
 
Any patients with missing all follow up data will be deemed to have not 
completed follow up and will be excluded with a withdrawal form completed.  
If partial follow up data is available we will use this in analysis. 
 
10.4. 
Transfer of Data 
 
There is no plan for patient identifiable data to be transferred between 
collaborators, de-identified data could be sent via NHSmail to other NHSmail 
accounts.  All analysis will be performed on secure password protected 
computers with data extracted from Surgical Outcomes System.  All data is de-
identified – see appendix 11.  This is a single site study. 
 
11.  
TRIAL/STUDY MANAGEMENT AND OVERSIGHT ARRANGEMENTS 
11.1. 
Trial/Study Management Group 
 
The trial/study will be co-ordinated by Mr Lawrie, Mr Ashcroft and Miss 
Hamlin.  They will form the trial steering committee (TSC).  Mr Lawrie as Chief 
Investigator, Mr Ashcroft is an Orthopaedic Consultant experienced in research 
and Miss Hamlin as Principle Investigator.  The TSC will meet annually and 
operate as per sponsors SOP. 
 
11.2. 
Trial/Study Management 
 
Miss Hamlin will oversee the study and will be accountable to Mr. Lawrie. The 
Clinical Research Fellow/Orthopaedic registrar/Research Nurse  will be 
responsible for checking the CRFs for completeness, plausibility and 
consistency. However, this remains the overall responsibility of the CI. Any 
queries will be resolved by the CI or delegated member of the study team.  
A study-specific Delegation Log will be prepared for the site, detailing the 
responsibilities of each member of staff working on the study.  
 
12.  
INSPECTION OF RECORDS 
 
The CI, PIs and all institutions involved in the study will permit study related 
monitoring, audits, and REC review. The CI agrees to allow the Sponsor or, 
representatives of the Sponsor, direct access to all study records and source 
documentation. 
 
 
 

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13.  
GOOD CLINICAL PRACTICE 
13.1. 
Ethical Conduct of the Study 
 
The study will be conducted in accordance with the principles of good clinical 
practice (GCP). 
In addition to Sponsorship approval, a favorable ethical opinion will be 
obtained from the appropriate REC and appropriate NHS R&D approval(s) will 
be obtained prior to commencement of the study. 
 
13.1.1 Confidentiality 
 All evaluation forms, reports, and other records will be identified in a manner 
designed to maintain participant confidentiality.  Patient CRFs will only contain 
study specific data and study identification. 
 
All paper records will be kept in a secure storage area with limited access to 
study staff only. Anonymised patient data (written on case report forms) will 
be stored in a locked filing cabinet in the Upper Limb Unit Secretaries office, 
which is itself secured.  Only the research team will have access to this data. 
Electronic records will be stored in Arthrex Surgical Outcomes System (SOS).  
SOS is hosted on servers operated exclusively for Arthrex by Amazon Web 
Services, Inc. (AWS). The servers are located in a data centre in Virginia, United 
States, until 2018 when SOS will be separated into two systems, EMEA and USA.   
EMEA data will then be stored on an AWS Server in Germany. The data centre has 
multiple layers of operational and physical security to ensure the integrity and 
safety of the data. The data centre utilizes state-of-the-art electronic 
surveillance and multi-factor access control systems. The data centre is staffed 
24 / 7 by trained security guards and access is authorized on a least privileged 
basis.  See also appendix 11.   
Data files from SOS will be extracted onto NHS computers as password 
protected excel files will be stored on secure shared NHS Grampian drive, with 
access only to research team.   
Clinical information will not be released without the written permission of the 
participant, except as necessary for monitoring and auditing by the Sponsor or 
its designee. The CI and study staff involved with this study will not disclose or 
use for any purpose other than performance of the study, any data, record, or 
other unpublished, confidential information disclosed to those individuals for 
the purpose of the study. Prior written agreement from the Sponsor or its 
designee will be obtained for the disclosure of any said confidential 
information to other parties. 
This study will be using a specially designed outcomes portfolio and as such our 
data will not be available for global comparison. 
The investigator will keep a record of the study ID to enable his research team 
to track patients involved in the study. 

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13.1.2 Data Protection  
 The CI and study staff involved with this project will comply with the 
requirements of the General Data Protection Regulations (GDPR) and the Data 
Protection Act 2018. The HRA recommended wording to fulfil transparency 
requirements under the GDPR for health and care research has been included 
in the PIS. 
The CI and study staff will also adhere, if appropriate, to the current version of 
the NHS Scotland Code of Practice on Protecting Patient Confidentiality.  Access 
to collated participant data will be restricted to the CI and appropriate study 
staff. 
Computers used to collate the data will have limited access measures via user 
names and passwords. 
Published results will not contain any personal data that could allow 
identification of individual participants. 
 
13.1.3 Insurance and Indemnity 
 The NHS Grampian Health Board and The University of Aberdeen are Co-
Sponsoring the study. 
 
Insurance:  Grampian Health Board will maintain its membership of the Clinical 
Negligence and Other Risks Insurance Scheme (“CNORIS”) which covers the 
legal liability of Grampian in relation to the study]. 
 
Indemnity: The Sponsors do not provide study participants with indemnity in 
relation to participation in the Study but has insurance for legal liability as 
described above. 
 
14.  
STUDY CONDUCT RESPONSIBILITIES 
14.1. 
Protocol Amendments, Deviations and Breaches 
 
The CI will seek approval for any amendments to the Protocol or other study 
documents from the Sponsor, REC and NHS R&D Office. Amendments to the 
protocol or other study docs will not be implemented without these approvals.  
In the event that a CI needs to deviate from the protocol, the nature of and 
reasons for the deviation will be recorded in the CRF, documented and 
submitted to the Sponsor. If this necessitates a subsequent protocol 
amendment, this will be submitted to the Sponsor for approval and then to the 
appropriate REC and lead NHS R&D Office for review and approval.  
In the event that a serious breach of GCP is suspected, this will be reported to 
the Sponsor immediately using the form “Breach Report Form”.  
 
 
 

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14.2. 
Study Record Retention 
 
Archiving of study documents will be maintained for 7 years, in accordance 
with the sponsors archiving SOP and the documents will be stored off site using 
the dedicated NHSG achieve by Removal Services Scotland. After this time they 
will be securely disposed of.  De-identified data will be available on SOS unless 
a patient or user unsubscribes, the study will be unsubscribed after 7 years and 
the data deleted. 
 
14.3. 
End of Study 
 
The end of study is defined as last patient last visit (LPLV). The Sponsor, CI 
and/or the TSC have the right at any time to terminate the study for clinical or 
administrative reasons.  
The end of the study will be reported to the Sponsor and REC within 90 days, or 
15 days if the study is terminated prematurely. The CI will ensure that any 
appropriate follow up is arranged for all participants. 
A summary report of the study will be provided to the Sponsor and REC within 
1 year of the end of the study 
 
15.  
REPORTING, PUBLICATIONS AND NOTIFICATION OF RESULTS 
15.1. 
Authorship Policy 
 
Ownership of the data arising from this study resides with the study team and 
their respective employers. On completion of the study, the study data will be 
analyzed and tabulated, and a clinical study report will be prepared.  
 
15.2. 
Publication 
 
The clinical study report will be used for publication and presentation at 
scientific meetings. Investigators have the right to publish orally or in writing 
the results of the study. 
Summaries of results will also be made available to Investigators for 
dissemination within their clinical areas (where appropriate and according to 
their discretion). 
 
15.3. 
Peer Review 
Internal peer review has been undertaken by Mr Scott Barker, Consultant 
Orthopaedic Surgeon and Mrs Carol Carnegie, Research Nurse.  The study was 
also reviewed by Arthrex during the funding application. 
 
 

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16.  
FUNDING and EQUIPMENT 
Arthrex, an orthopaedic medical device company, is providing funding in 
the form of supply of disposable material and research support.  They will 
provide up to 100 units of the ACP double syringe.  This is used to collect 
the blood sample, process the PRP and inject the PRP into the ganglion 
(see Appendix 3).  The processing is performed by a centrifuge, provided 
by Arthrex, in the Orthopaedic out-patient department.  This is already in 
place.  Arthrex provide indemnity for the centrifuge (Indemnity number 
MIA No: 310/13).  Both the ACP double syringe and the centrifuge are 
already in use in NHS Grampian.  PRP injections are currently performed 
for other conditions i.e. Tennis Elbow and Achilles Tendonitis.   
 
Research support will be provided in the form of data management via 
SOS and statistical support and final analysis. 
 
There are no other additional costs out with the usual treatment costs.

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APPENDIX 1: References 
 
References   
1. E A Athanasian. Green’s Operative Hand Surgery. Ed: D P Green, R N Hotchkiss, W C 
Pederson, S W Wolfe. Fifth Edition 2005. pp. 2211 – 2265   
2. Psaila JV, Mansel RE.  The Surface Ultrastructure of Ganglia.  JBJS Br. 1978;60B(2):228-
233 
3. Meena S, Gupta A. Dorsal Wrist Ganglion:  Current Review of the literature. 
4. Angelides AC, Wallace PF.  The dorsal ganglion of the wrist its pathogenesis, gross and 
microscopic anatomy, and surgical treatment. J Hand Surg. 1976;1(3):228-235. 
5. Janzon L, Niechajev IA. Wrist ganglia. Incidence and recurrence rate after operation. 
Scand J Plast Reconstr Surg. 1981;15(1):53-6.   
6. C M Lowden, M Attiah, G Garvin, J C Macdermid, S Osman, K J Faber. The prevalence of 
wrist ganglia in an asymptomatic population: magnetic resonance evaluation. Journal of 
hand surgery (Br). 2005 vol. 30 (3) pp. 302-6   
7. F D Burke, E Y Melikyan, M J Bradley, J J Dias. Primary care referral protocol for wrist 
ganglia. Postgraduate medical journal. 2003 vol. 79 (932) pp. 329-31   
8. A P Westbrook, A B Stephen, J Oni, T R Davis. Ganglia: the patient's perception. Journal 
of hand surgery (Br). 2000 vol. 25 (6) pp. 566-7   
9. J J Osterwalder, R Widrig, R Stober, A Gächter. Diagnostic validity of ultrasound in 
patients with persistent wrist pain and suspected occult ganglion. The Journal of Hand 
Surgery (Am). 1997 vol. 22 (6) pp. 1034-40   
10. S Goldsmith, S S Yang. Magnetic resonance imaging in the diagnosis of occult dorsal wrist 
11. Marx R.  Platelet-Rich Plasma (PRP): What is PRP and What is not PRP? Implant dentistry. 
2001:10(4);225-228 
12. Valente Duarte de Sousa, Isabel Cristina; Tosti, Antonella (May 2013). "New 
investigational drugs for androgenetic alopecia". Expert Opinion on Investigational Drugs 
22 (5): 573–589. 
13. Yu W, Wang J, Yin J (2011). "Platelet-Rich Plasma: A Promising Product for Treatment of 
Peripheral Nerve Regeneration After Nerve Injury". Int J Neurosci 121 (4): 176–180 
14. Freymiller EG, Aghaloo TL platelet rich plasma ready or not. J oral Maxillofac surg 
2004;62:484-488 
15. Marx RE platelet rich plasma: evidence to support its use. J Oral Maxillofac surg. 
2004.62;489-496 
 
 
 

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APPENDIX 2: Patient Reported Measure 
 
PATIENT EVALUATED MEASURE SCORE (PEMS) 
 
Part 1 – Treatment:  
 
 Please put a circle around the number that is closest to the way you feel about how things have been for you.  There 
are no right or wrong answers. 
 
1. Throughout my treatment I have seen the same doctor:  
1          2          3          4          5          6          7 
Every time 
Not at all 
2. When the doctor saw me, he or she knew about my case: 
1          2          3          4          5          6          7 
Very well 
Not at all 
3. When I was with the doctor, her or she gave me the chance to talk: 
1          2          3          4          5          6          7 
As much as I wanted 
Not at all 
4. When I did talk to the doctor, he or she listened and understood me: 
1          2          3          4          5          6          7 
Very much 
Not at all 
5. I was given information about my treatment and prognosis: 
1          2          3          4          5          6          7 
All that I wanted 
Not at all 
 
 
Part two – How is your hand now? 
 
Hand Health Profile 
1. The feeling in my hand is now: 
 
1          2          3          4          5          6          7 
Normal 
Absent 
 
 
2. When my hand is cold and/or damp, the pain is now: 
1          2          3          4          5          6          7 
Non-existent 
Unbearable 
 
 
3. Most of the time , the pain in my hand is now: 
1          2          3          4          5          6          7 
Non-existent 
Unbearable 
 
 
4. The duration my pain is present is: 
1          2          3          4          5          6          7 
Never 
All the time 
 

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5. When I try to use my hand for fiddly things, it is now: 
1          2          3          4          5          6          7 
Skilful 
Clumsy 
 
6. General, when I move my hand it is: 
1          2          3          4          5          6          7 
Flexible 
Stiff 
 
7. The grip in my hand is now: 
1          2          3          4          5          6          7 
Strong 
Weak 
 
8. For everyday activities, my hand is now: 
1          2          3          4          5          6          7 
No problem 
Useless 
 
9. For work, my hand is now: 
1          2          3          4          5          6          7 
No problem 
Useless 
 
10. When I look at the appearance of my hand now, I feel: 
1          2          3          4          5          6          7 
Unconcerned 
Embarrassed & self-conscious 
 
11. Generally, when I think about my hand I feel: 
1          2          3          4          5          6          7 
Unconcerned 
Very upset 
 
Part three – overall assessment 
 
1. Generally, my treatment at the hospital has been: 
1          2          3          4          5          6          7 
Very satisfactory 
Very unsatisfactory 
 
2. Generally, my hand is now: 
1          2          3          4          5          6          7 
Very satisfactory 
Very satisfactory 
 
3. Bearing in mind my original condition, I feel my hand is now: 
1          2          3          4          5          6          7 
Better than expected 
Worse than expected 
 
 
 

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APPENDIX 3: Processing Procedure for PRP 
 
 
 

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APPENDIX 4:  Study Flow Diagram 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Telephone/ Clinical review 7-14 days (KH/OR) 
 Ask about ganglion recurrence 
 Complete PEMS 
 
Telephone/Email contact 12 months (OR/RN) 
 Ask about ganglion recurrence 
 Complete PEMS 
Study Participation Complete 
 
Initial Assessment/ Intervention (DFML/KH/OR) 
 Trial Induction 
 Consent if agree 
 Complete PEMS and demographics 
 Intervention (at 2nd visit according to patient wishes) 
o Randomisation  
o Blood sampling and process to get PRP if in injection group 
o Aspiration +/- Injection of PRP 
o Pressure dressing 48hrs and home 
 
Patient Identification 
 Letter of invitation and patient information sent 
Telephone/ Email Contact 6 weeks (OR/RN) 
 Ask about ganglion recurrence 
 Complete PEMS 
 

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Appendix 5 
 
See attached documents: 
 
Patient Information Leaflet  
 
GP Letter 
 
Consent Form 
 
Case Report Forms 
 
Trial Steering Committee Charter 
 
 
SOS_FAQ 
 
EMEA SOS Privacy and Security Flyer