Dorsal Wrist Ganglia; Aspiration Alone vs Aspiration and Injection of Platelet Rich Plasma

• Sponsor: University of Aberdeen (Other)
• Overall Status: Completed
• CT.gov ID: NCT03408808
• Collaborator: NHS Grampian (Other), Arthrex, Inc. (Industry)
• Enrollment: 17
• Location: 1
• Arms: 2
• Actual Duration (Months): 26.1
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

Study to examine the efficacy of Platelet Rich Plasma (PRP) to reduce recurrence in dorsal wrist ganglia (DWG). 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. They will be asked to complete a questionnaire and a Patient Evaluated Measure score (PEMS). Adverse events will be screened for/ managed by a telephone call +/- review as necessary between 7 and 14 days.

Condition or Disease	Intervention/Treatment	Phase
Ganglion of Wrist	Procedure: Platelet rich plasma; Procedure: Aspiration alone	N/A

Detailed 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.

1. Assess eligibility/ enrolment in study - clinic visit 1

2. All patients assessed by the chief investigator Mr David Lawrie (DFML) or Miss Katharine Hamlin (KH).

3. Clinical assessment of presence of ganglion.

4. Ensure not meeting exclusion criteria.

5. If eligible and willing to complete study commitments discuss study and answer questions.

6. 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.

7. If they are willing to participate they will then be offered treatment in the same visit or a return visit

8. Intervention - clinic visit 1 or 2

9. Check understanding and continuing desire to participate in study if 2nd visit.

10. Complete consent form.

11. Patient fills out a PEM score and demographics collected on SOS (Surgical Outcomes System - Arthrex).

12. Randomisation.

13. If in PRP group 15ml blood sample taken with Arthrex ACP double syringe and processed (see processing instructions in Appendix.9.

14. Aspiration.

15. If in PRP group - Injection of PRP (the same volume as aspirated).

16. Pressure dressing with gauze, wool and crepe for 48 hours.

17. Adverse event screening/ management Patients are offered two options at the treatment visit.

18. 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 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.

1. SOS/ Email/ Telephone interview - 1 (6 weeks)

1. Ganglion questionnaire b) PEM score c) Note any adverse events

1. SOS/ Email /Telephone interview - 2 (12 months)

2. Ganglion questionnaire

3. PEM score

4. Note any adverse events

Study Design

• Study Type: Interventional
• Actual Enrollment: 17 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomised controlled trial with two arms. Control - Aspiration alone. Intervention - aspiration plus injection of platelet righ plasma.Randomised controlled trial with two arms. Control - Aspiration alone. Intervention - aspiration plus injection of platelet righ plasma.
• Masking: Single (Outcomes Assessor)
• Masking Description: The outcomes assessor will be blinded to the treatment received.
• Primary Purpose: Treatment
• Official Title: Dorsal Wrist Ganglia; Aspiration Alone vs Aspiration and Injection of Platelet Rich Plasma
• Actual Study Start Date: Dec 5, 2018
• Actual Primary Completion Date: Feb 5, 2021
• Actual Study Completion Date: Feb 5, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Aspiration alone The patients will have their dorsal wrist ganglion aspirated and then pressure dressing for 48 hours.	Procedure: Aspiration alone; Aspiration of the ganglion
Experimental: Aspiration plus platelet rich plasma The patients will have their dorsal wrist ganglion aspirated, and then injected with platelet rich plasma (derived from a blood sample taken at the same visit) and then pressure dressing for 48 hours.	Procedure: Platelet rich plasma; Aspiration of ganglion and injection with platelet rich plasma.; Other Names: PRP

Outcome Measures

Primary Outcome Measures

1. Number of Participants With a Recurrence of Ganglia [6 weeks]

   Has the ganglion returned?

2. Number of Participants With a Recurrence of Ganglia [12 months]

   Has the ganglion returned?

Secondary Outcome Measures

1. PEM Score [6 weeks]

   The Patient Evaluation Measure (PEM) (Macey and Burke, 1995) is used to measure outcomes in hand surgery. It consists of a series of 18 questions, which address different aspects of symptoms pertaining to the hand and hand function. The questions have been split into three sections, the first being five questions on treatment. The second section contains ten questions on the condition of your hand at this moment in time (Feeling, Cold intolerance, Pain, Dexterity, Movement, Grip, ADL, Work, Appearance and Hand in general) and the third section is an overall assessment containing three questions. Each question from sections two and three are marked from 1-7, 7 being the worst outcome and 1 being the best outcome. The answers are expressed as a percentage disability ranging from zero to 100, with lower scores indicating less disability and are therefore better. This questionnaire is reliable, valid and responsive for assessing wrist disorders (Dias et al., 2001).

2. PEM Score [12 months]

   The Patient Evaluation Measure (PEM) (Macey and Burke, 1995) is used to measure outcomes in hand surgery. It consists of a series of 18 questions, which address different aspects of symptoms pertaining to the hand and hand function. The questions have been split into three sections, the first being five questions on treatment. The second section contains ten questions on the condition of your hand at this moment in time (Feeling, Cold intolerance, Pain, Dexterity, Movement, Grip, ADL, Work, Appearance and Hand in general) and the third section is an overall assessment containing three questions. Each question from sections two and three are marked from 1-7, 7 being the worst outcome and 1 being the best outcome. The answers are expressed as a percentage disability ranging from zero to 100, with lower scores indicating less disability and are therefore better. This questionnaire is reliable, valid and responsive for assessing wrist disorders (Dias et al., 2001).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Solitary dorsal wrist ganglion.

Exclusion Criteria:

• Underlying wrist or ipsilateral arm pathology.

• Unable to consent to treatment.

• Unable or unwilling to attend follow up visits.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NHS Grampian	Aberdeen		United Kingdom	AB25 2ZB

Sponsors and Collaborators

• University of Aberdeen
• NHS Grampian
• Arthrex, Inc.

Investigators

• Principal Investigator: Katharine Hamlin, MBChB, NHS Grampian

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 3, 2018
• Informed Consent Form - Jun 3, 2018

More Information

Publications

• Freymiller EG, Aghaloo TL. Platelet-rich plasma: ready or not? J Oral Maxillofac Surg. 2004 Apr;62(4):484-8. Review.
• Janzon L, Niechajev IA. Wrist ganglia. Incidence and recurrence rate after operation. Scand J Plast Reconstr Surg. 1981;15(1):53-6.
• Marx RE. Platelet-rich plasma (PRP): what is PRP and what is not PRP? Implant Dent. 2001;10(4):225-8.
• Marx RE. Platelet-rich plasma: evidence to support its use. J Oral Maxillofac Surg. 2004 Apr;62(4):489-96. Review.
• Meena S, Gupta A. Dorsal wrist ganglion: Current review of literature. J Clin Orthop Trauma. 2014 Jun;5(2):59-64. doi: 10.1016/j.jcot.2014.01.006. Epub 2014 Jun 3. Review. Retraction in: J Clin Orthop Trauma. 2020 Sep 17;11(Suppl 5):S916.
• Valente Duarte de Sousa IC, Tosti A. New investigational drugs for androgenetic alopecia. Expert Opin Investig Drugs. 2013 May;22(5):573-89. doi: 10.1517/13543784.2013.784743. Epub 2013 Apr 4. Review. Erratum in: Expert Opin Investig Drugs. 2015 May;24(5):735.
• Yu W, Wang J, Yin J. Platelet-rich plasma: a promising product for treatment of peripheral nerve regeneration after nerve injury. Int J Neurosci. 2011 Apr;121(4):176-80. doi: 10.3109/00207454.2010.544432. Epub 2011 Jan 19.

• Responsible Party: University of Aberdeen
• ClinicalTrials.gov Identifier: NCT03408808
• Other Study ID Numbers: 1/091/17
• First Posted: Jan 24, 2018
• Last Update Posted: Jun 24, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Aberdeen: wrist; ganglion; platelet rich plasma; aspiration
• Additional relevant MeSH terms: Ganglion Cysts; Synovial Cyst

Study Results

Participant Flow

Arm/Group Title	Aspiration Alone	Aspiration Plus Platelet Rich Plasma
Arm/Group Description	The patients will have their dorsal wrist ganglion aspirated and then pressure dressing for 48 hours. Aspiration alone: Aspiration of the ganglion	The patients will have their dorsal wrist ganglion aspirated, and then injected with platelet rich plasma (derived from a blood sample taken at the same visit) and then pressure dressing for 48 hours. Platelet rich plasma: Aspiration of ganglion and injection with platelet rich plasma.
Period Title: Overall Study
STARTED	8	9
COMPLETED	8	8
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Aspiration Alone	Aspiration Plus Platelet Rich Plasma	Total
Arm/Group Description	The patients will have their dorsal wrist ganglion aspirated and then pressure dressing for 48 hours. Aspiration alone: Aspiration of the ganglion	The patients will have their dorsal wrist ganglion aspirated, and then injected with platelet rich plasma (derived from a blood sample taken at the same visit) and then pressure dressing for 48 hours. Platelet rich plasma: Aspiration of ganglion and injection with platelet rich plasma.	Total of all reporting groups
Overall Participants	8	9	17
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	33.9	23.2	28.6
Sex: Female, Male (Count of Participants)
Female	7 87.5%	7 77.8%	14 82.4%
Male	1 12.5%	2 22.2%	3 17.6%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United Kingdom	8 100%	9 100%	17 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With a Recurrence of Ganglia
Description	Has the ganglion returned?
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aspiration Alone	Aspiration Plus Platelet Rich Plasma
Arm/Group Description	The patients will have their dorsal wrist ganglion aspirated and then pressure dressing for 48 hours. Aspiration alone: Aspiration of the ganglion	The patients will have their dorsal wrist ganglion aspirated, and then injected with platelet rich plasma (derived from a blood sample taken at the same visit) and then pressure dressing for 48 hours. Platelet rich plasma: Aspiration of ganglion and injection with platelet rich plasma.
Measure Participants	8	8
Count of Participants [Participants]	8 100%	5 55.6%

2. Primary Outcome

Title	Number of Participants With a Recurrence of Ganglia
Description	Has the ganglion returned?
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aspiration Alone	Aspiration Plus Platelet Rich Plasma
Arm/Group Description	The patients will have their dorsal wrist ganglion aspirated and then pressure dressing for 48 hours. Aspiration alone: Aspiration of the ganglion	The patients will have their dorsal wrist ganglion aspirated, and then injected with platelet rich plasma (derived from a blood sample taken at the same visit) and then pressure dressing for 48 hours. Platelet rich plasma: Aspiration of ganglion and injection with platelet rich plasma.
Measure Participants	8	8
Count of Participants [Participants]	3 37.5%	7 77.8%

3. Secondary Outcome

Title	PEM Score
Description	The Patient Evaluation Measure (PEM) (Macey and Burke, 1995) is used to measure outcomes in hand surgery. It consists of a series of 18 questions, which address different aspects of symptoms pertaining to the hand and hand function. The questions have been split into three sections, the first being five questions on treatment. The second section contains ten questions on the condition of your hand at this moment in time (Feeling, Cold intolerance, Pain, Dexterity, Movement, Grip, ADL, Work, Appearance and Hand in general) and the third section is an overall assessment containing three questions. Each question from sections two and three are marked from 1-7, 7 being the worst outcome and 1 being the best outcome. The answers are expressed as a percentage disability ranging from zero to 100, with lower scores indicating less disability and are therefore better. This questionnaire is reliable, valid and responsive for assessing wrist disorders (Dias et al., 2001).
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aspiration Alone	Aspiration Plus Platelet Rich Plasma
Arm/Group Description	The patients will have their dorsal wrist ganglion aspirated and then pressure dressing for 48 hours. Aspiration alone: Aspiration of the ganglion	The patients will have their dorsal wrist ganglion aspirated, and then injected with platelet rich plasma (derived from a blood sample taken at the same visit) and then pressure dressing for 48 hours. Platelet rich plasma: Aspiration of ganglion and injection with platelet rich plasma.
Measure Participants	8	8
Mean (Full Range) [score on a scale]	40.2	38.7

4. Secondary Outcome

Title	PEM Score
Description	The Patient Evaluation Measure (PEM) (Macey and Burke, 1995) is used to measure outcomes in hand surgery. It consists of a series of 18 questions, which address different aspects of symptoms pertaining to the hand and hand function. The questions have been split into three sections, the first being five questions on treatment. The second section contains ten questions on the condition of your hand at this moment in time (Feeling, Cold intolerance, Pain, Dexterity, Movement, Grip, ADL, Work, Appearance and Hand in general) and the third section is an overall assessment containing three questions. Each question from sections two and three are marked from 1-7, 7 being the worst outcome and 1 being the best outcome. The answers are expressed as a percentage disability ranging from zero to 100, with lower scores indicating less disability and are therefore better. This questionnaire is reliable, valid and responsive for assessing wrist disorders (Dias et al., 2001).
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aspiration Alone	Aspiration Plus Platelet Rich Plasma
Arm/Group Description	The patients will have their dorsal wrist ganglion aspirated and then pressure dressing for 48 hours. Aspiration alone: Aspiration of the ganglion	The patients will have their dorsal wrist ganglion aspirated, and then injected with platelet rich plasma (derived from a blood sample taken at the same visit) and then pressure dressing for 48 hours. Platelet rich plasma: Aspiration of ganglion and injection with platelet rich plasma.
Measure Participants	8	8
Mean (Full Range) [score on a scale]	35	40.6

Adverse Events

Time Frame	1 year
Arm/Group Title	Aspiration Alone		Aspiration Plus Platelet Rich Plasma
Arm/Group Description	The patients will have their dorsal wrist ganglion aspirated and then pressure dressing for 48 hours. Aspiration alone: Aspiration of the ganglion		The patients will have their dorsal wrist ganglion aspirated, and then injected with platelet rich plasma (derived from a blood sample taken at the same visit) and then pressure dressing for 48 hours. Platelet rich plasma: Aspiration of ganglion and injection with platelet rich plasma.
All Cause Mortality
	Aspiration Alone		Aspiration Plus Platelet Rich Plasma
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/9 (0%)
Serious Adverse Events
	Aspiration Alone		Aspiration Plus Platelet Rich Plasma
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/9 (0%)
Other (Not Including Serious) Adverse Events
	Aspiration Alone		Aspiration Plus Platelet Rich Plasma
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/9 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.