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

Primary Purpose

Ganglion of Wrist

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Platelet rich plasma
Aspiration alone
Sponsored by
University of Aberdeen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ganglion of Wrist focused on measuring wrist, ganglion, platelet rich plasma, aspiration

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • NHS Grampian

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Aspiration alone

Aspiration plus platelet rich plasma

Arm Description

The patients will have their dorsal wrist ganglion aspirated and then pressure dressing for 48 hours.

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.

Outcomes

Primary Outcome Measures

Number of Participants With a Recurrence of Ganglia
Has the ganglion returned?
Number of Participants With a Recurrence of Ganglia
Has the ganglion returned?

Secondary Outcome Measures

PEM Score
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).
PEM Score
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).

Full Information

First Posted
January 16, 2018
Last Updated
June 1, 2021
Sponsor
University of Aberdeen
Collaborators
NHS Grampian, Arthrex, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03408808
Brief Title
Dorsal Wrist Ganglia; Aspiration Alone vs Aspiration and Injection of Platelet Rich Plasma
Official Title
Dorsal Wrist Ganglia; Aspiration Alone vs Aspiration and Injection of Platelet Rich Plasma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
December 5, 2018 (Actual)
Primary Completion Date
February 5, 2021 (Actual)
Study Completion Date
February 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aberdeen
Collaborators
NHS Grampian, Arthrex, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
Detailed Description
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. Assess eligibility/ enrolment in study - clinic visit 1 All patients assessed by the chief investigator Mr David Lawrie (DFML) or Miss Katharine Hamlin (KH). Clinical assessment of presence of ganglion. Ensure not meeting exclusion criteria. If eligible and willing to complete study commitments discuss study and answer 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 are willing to participate they will then be offered treatment in the same visit or a return visit Intervention - clinic visit 1 or 2 Check understanding and continuing desire to participate in study if 2nd visit. Complete consent form. Patient fills out a PEM score and demographics collected on SOS (Surgical Outcomes System - Arthrex). Randomisation. If in PRP group 15ml blood sample taken with Arthrex ACP double syringe and processed (see processing instructions in Appendix.9. Aspiration. If in PRP group - Injection of PRP (the same volume as aspirated). Pressure dressing with gauze, wool and crepe for 48 hours. 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 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) Ganglion questionnaire PEM score Note any adverse events

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ganglion of Wrist
Keywords
wrist, ganglion, platelet rich plasma, aspiration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised controlled trial with two arms. Control - Aspiration alone. Intervention - aspiration plus injection of platelet righ plasma.
Masking
Outcomes Assessor
Masking Description
The outcomes assessor will be blinded to the treatment received.
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aspiration alone
Arm Type
Active Comparator
Arm Description
The patients will have their dorsal wrist ganglion aspirated and then pressure dressing for 48 hours.
Arm Title
Aspiration plus platelet rich plasma
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Platelet rich plasma
Other Intervention Name(s)
PRP
Intervention Description
Aspiration of ganglion and injection with platelet rich plasma.
Intervention Type
Procedure
Intervention Name(s)
Aspiration alone
Intervention Description
Aspiration of the ganglion
Primary Outcome Measure Information:
Title
Number of Participants With a Recurrence of Ganglia
Description
Has the ganglion returned?
Time Frame
6 weeks
Title
Number of Participants With a Recurrence of Ganglia
Description
Has the ganglion returned?
Time Frame
12 months
Secondary Outcome Measure Information:
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katharine Hamlin, MBChB
Organizational Affiliation
NHS Grampian
Official's Role
Principal Investigator
Facility Information:
Facility Name
NHS Grampian
City
Aberdeen
ZIP/Postal Code
AB25 2ZB
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25983472
Citation
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.
Results Reference
background
PubMed Identifier
7268314
Citation
Janzon L, Niechajev IA. Wrist ganglia. Incidence and recurrence rate after operation. Scand J Plast Reconstr Surg. 1981;15(1):53-6. doi: 10.3109/02844318109103412.
Results Reference
background
PubMed Identifier
15085519
Citation
Marx RE. Platelet-rich plasma: evidence to support its use. J Oral Maxillofac Surg. 2004 Apr;62(4):489-96. doi: 10.1016/j.joms.2003.12.003. No abstract available.
Results Reference
background
PubMed Identifier
15085518
Citation
Freymiller EG, Aghaloo TL. Platelet-rich plasma: ready or not? J Oral Maxillofac Surg. 2004 Apr;62(4):484-8. doi: 10.1016/j.joms.2003.08.021. No abstract available.
Results Reference
background
PubMed Identifier
21244302
Citation
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.
Results Reference
background
PubMed Identifier
23550739
Citation
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. Erratum In: Expert Opin Investig Drugs. 2015 May;24(5):735.
Results Reference
background
PubMed Identifier
11813662
Citation
Marx RE. Platelet-rich plasma (PRP): what is PRP and what is not PRP? Implant Dent. 2001;10(4):225-8. doi: 10.1097/00008505-200110000-00002. No abstract available.
Results Reference
background

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

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