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

Ganglion of Wrist Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03408808
• Other study ID #: 1/091/17
• Status: Completed
• Phase: N/A
• Start date: December 5, 2018
• Est. completion date: February 5, 2021

Study information

• Verified date: June 2021
• Source: University of Aberdeen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: February 5, 2021
• Est. primary completion date: February 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ganglion Cysts
• Ganglion of Wrist

Intervention

Procedure:
• Platelet rich plasma
Aspiration of ganglion and injection with platelet rich plasma.
• Aspiration alone
Aspiration of the ganglion

Locations

Country	Name	City	State
United Kingdom	NHS Grampian	Aberdeen

Sponsors (3)

Lead Sponsor	Collaborator
University of Aberdeen	Arthrex, Inc., NHS Grampian

Country where clinical trial is conducted

United Kingdom, 

References & Publications (7)

Freymiller EG, Aghaloo TL. Platelet-rich plasma: ready or not? J Oral Maxillofac Surg. 2004 Apr;62(4):484-8. Review. — View Citation

Janzon L, Niechajev IA. Wrist ganglia. Incidence and recurrence rate after operation. Scand J Plast Reconstr Surg. 1981;15(1):53-6. — View Citation

Marx RE. Platelet-rich plasma (PRP): what is PRP and what is not PRP? Implant Dent. 2001;10(4):225-8. — View Citation

Marx RE. Platelet-rich plasma: evidence to support its use. J Oral Maxillofac Surg. 2004 Apr;62(4):489-96. Review. — View 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. Review. — View 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. Review. Erratum in: Expert Opin Investig Drugs. 2015 May;24(5):735. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With a Recurrence of Ganglia	Has the ganglion returned?	6 weeks
Primary	Number of Participants With a Recurrence of Ganglia	Has the ganglion returned?	12 months
Secondary	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).	6 weeks
Secondary	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).	12 months