Dorsal Wrist Ganglia; Aspiration Alone vs Aspiration and Injection of Platelet Rich Plasma
NCT ID: NCT03408808
Last Updated: 2021-06-24
Study Results
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View full resultsBasic Information
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COMPLETED
NA
17 participants
INTERVENTIONAL
2018-12-05
2021-02-05
Brief Summary
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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.
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Aspiration alone
The patients will have their dorsal wrist ganglion aspirated and then pressure dressing for 48 hours.
Aspiration alone
Aspiration of the ganglion
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.
Platelet rich plasma
Aspiration of ganglion and injection with platelet rich plasma.
Interventions
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Platelet rich plasma
Aspiration of ganglion and injection with platelet rich plasma.
Aspiration alone
Aspiration of the ganglion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Unable to consent to treatment.
* Unable or unwilling to attend follow up visits.
16 Years
ALL
No
Sponsors
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NHS Grampian
OTHER_GOV
Arthrex, Inc.
INDUSTRY
University of Aberdeen
OTHER
Responsible Party
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Principal Investigators
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Katharine Hamlin, MBChB
Role: PRINCIPAL_INVESTIGATOR
NHS Grampian
Locations
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NHS Grampian
Aberdeen, , United Kingdom
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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1/091/17
Identifier Type: -
Identifier Source: org_study_id
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