Clinical trial NCT03408808: 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
Overall status: COMPLETED
Phase: NA
Conditions: Ganglion of Wrist
Keywords: wrist
ganglion
platelet rich plasma
aspiration
Lead sponsor: University of Aberdeen
Sponsor class: OTHER
Collaborators: name: NHS Grampian
name: Arthrex, Inc.
First posted: 2018-01-24
Enrollment: 17
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trial with two arms. Control - Aspiration alone. Intervention - aspiration plus injection of platelet righ plasma.
Primary purpose: TREATMENT

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: 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/ enrolment in study - clinic visit 1

   1. All patients assessed by the chief investigator Mr David Lawrie (DFML) or Miss Katharine Hamlin (KH).
   2. Clinical assessment of presence of ganglion.
   3. Ensure not meeting exclusion criteria.
   4. If eligible and willing to complete study commitments discuss study and answer questions.
   5. 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.
   6. 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

   1. Check understanding and continuing desire to participate in study if 2nd visit.
   2. Complete consent form.
   3. Patient fills out a PEM score and demographics collected on SOS (Surgical Outcomes System - Arthrex).
   4. Randomisation.
   5. If in PRP group 15ml blood sample taken with Arthrex ACP double syringe and processed (see processing instructions in Appendix.9.
   6. Aspiration.
   7. If in PRP group - Injection of PRP (the same volume as aspirated).
   8. 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 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)

1. Ganglion questionnaire
2. PEM score
3. Note any adverse events

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.

Primary outcomes:
measure: Number of Participants With a Recurrence of Ganglia
timeFrame: 6 weeks
measure: Number of Participants With a Recurrence of Ganglia
timeFrame: 12 months
Secondary outcomes:
measure: PEM Score
timeFrame: 6 weeks
measure: PEM Score
timeFrame: 12 months
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: NHS Grampian
Study officials:
affiliation: NHS Grampian
name: Katharine Hamlin, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.