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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Ganglion of Wrist

Intervention / Treatment
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* Procedure: Platelet rich plasma
* Procedure: Aspiration alone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised controlled trial with two arms. Control - Aspiration alone. Intervention - aspiration plus injection of platelet righ plasma.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aspiration alone<br>The patients will have their dorsal wrist ganglion aspirated and then pressure dressing for 48 hours. | Procedure: Aspiration alone<br>* Aspiration of the ganglion<br>|
| Experimental: Aspiration plus platelet rich plasma<br>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. | Procedure: Platelet rich plasma<br>* Aspiration of ganglion and injection with platelet rich plasma.<br>* Other names: PRP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With a Recurrence of Ganglia | Has the ganglion returned? | 6 weeks | 
| Number of Participants With a Recurrence of Ganglia | Has the ganglion returned? | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wrist, ganglion, platelet rich plasma, aspiration