Ganglion of WristNCT03408808
Dorsal Wrist Ganglia; Aspiration Alone vs Aspiration and Injection of Platelet Rich Plasma
A study testing Platelet rich plasma and Aspiration alone in people with Ganglion of Wrist, run by University of Aberdeen at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Ganglion of Wrist
- What is being tested?
- Platelet rich plasma and Aspiration alone
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Dec 2018to 5 Feb 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Solitary dorsal wrist ganglion.
Who cannot join
- Underlying wrist or ipsilateral arm pathology.
- Unable to consent to treatment.
- Unable or unwilling to attend follow up visits.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- 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.
- SOS/ Email/ Telephone interview - 1 (6 weeks)
- Ganglion questionnaire b) PEM score c) Note any adverse events
- SOS/ Email /Telephone interview - 2 (12 months)
- Ganglion questionnaire
- PEM score
- Note any adverse events
- Conditions
- Ganglion of Wrist
- Being tested
- Platelet rich plasma, Aspiration alone
- Keywords
- wrist, ganglion, platelet rich plasma, aspiration
- Medical subject headings
- Ganglion Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet rich plasmaProcedure or surgery
Also called PRP
Aspiration of ganglion and injection with platelet rich plasma.
Aspiration aloneProcedure or surgery
Aspiration of the ganglion
| Study group | Role | What they receive |
|---|---|---|
| Aspiration alone | Active comparator | The patients will have their dorsal wrist ganglion aspirated and then pressure dressing for 48 hours. Receives: Procedure: Aspiration alone |
| Aspiration plus platelet rich plasma | Experimental | 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. Receives: Procedure: Platelet rich plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Recurrence of Ganglia
Has the ganglion returned?
Measured: 6 weeks
Number of Participants With a Recurrence of Ganglia
Has the ganglion returned?
Measured: 12 months
Secondary outcomes (2)
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).
Measured: 6 weeks
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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start5 Dec 2018
- Primary completion5 Feb 2021
- Study completion5 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Ganglion of WristStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial with two arms. Control - Aspiration alone. Intervention - aspiration plus injection of platelet righ plasma.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Grampian, Arthrex, Inc.
- Responsible party
- Sponsor
- Investigators
- Katharine Hamlin, MBChB, Principal investigator, NHS Grampian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03408808
- Sponsor's protocol ID
- 1/091/17
- Status last verified
- Jun 2021
- First submitted
- 16 Jan 2018
- Last updated
- 24 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25983472Janzon 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.
PubMed 7268314Marx 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.
PubMed 15085519Freymiller 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.
PubMed 15085518Yu 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.
PubMed 21244302Valente 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.
PubMed 23550739Marx 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.
PubMed 11813662
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dorsal Wrist Ganglia; Aspiration Alone vs Aspiration and Injection of Platelet Rich Plasma
- ClinicalTrials.gov ID
- NCT03408808
- Acronym / sponsor ID
- 1/091/17
- Conditions
- Ganglion of Wrist
- Keywords
- wrist, ganglion, platelet rich plasma, aspiration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Collaborators
- NHS Grampian, Arthrex, Inc.
- Study start
- 5 Dec 2018 (actual)
- Primary completion
- 5 Feb 2021 (actual)
- Study completion
- 5 Feb 2021 (actual)
- First posted
- 24 Jan 2018 (actual)
- Results
- Posted 24 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- SOS/ Email/ Telephone interview - 1 (6 weeks)
- Ganglion questionnaire b) PEM score c) Note any adverse events
- SOS/ Email /Telephone interview - 2 (12 months)
- Ganglion questionnaire
- PEM score
- Note any adverse events
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised controlled trial with two arms. Control - Aspiration alone. Intervention - aspiration plus injection of platelet righ plasma.
| Arm | Type | Receives |
|---|---|---|
| Aspiration alone | Active comparator | Procedure: Aspiration aloneThe patients will have their dorsal wrist ganglion aspirated and then pressure dressing for 48 hours. |
| Aspiration plus platelet rich plasma | Experimental | Procedure: Platelet rich plasmaThe 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Solitary dorsal wrist ganglion.
Key exclusion criteria (3 listed)
- Underlying wrist or ipsilateral arm pathology.
- Unable to consent to treatment.
- Unable or unwilling to attend follow up visits.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet rich plasmaAlso: PRPAspiration of ganglion and injection with platelet rich plasma. | Procedure or surgery | Aspiration plus platelet rich plasma |
| Aspiration aloneAspiration of the ganglion | Procedure or surgery | Aspiration alone |
Primary outcome
Number of Participants With a Recurrence of Ganglia
Time frame: 6 weeks
Has the ganglion returned?
Number of Participants With a Recurrence of Ganglia
Time frame: 12 months
Has the ganglion returned?
2 secondary outcomes
PEM Score
Time frame: 6 weeks
PEM Score
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25983472Meena 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.
- Background: PubMed 7268314Janzon 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.
- Background: PubMed 15085519Marx 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.
- Background: PubMed 15085518Freymiller 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.
- Background: PubMed 21244302Yu 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.
- Background: PubMed 23550739Valente 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.
- Background: PubMed 11813662Marx 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.
- Individual participant dataSharing planned: No
Related trials for Ganglion of Wrist
Recruiting
Ganglion Resection Effectiveness Trial
Wrist Ganglion, Ganglion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katharine Hamlin, MBChB principal investigator
NHS Grampian
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet rich plasma and Aspiration alone in people with Ganglion of Wrist, run by University of Aberdeen at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With a Recurrence of Ganglia (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03408808, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2021.