| Registry | NCT03408808 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 17 (Actual) |
| Sponsor | University of Aberdeen (Other); collaborators: NHS Grampian, Arthrex, Inc. |
| Conditions | Ganglion of Wrist |
| Interventions | Platelet rich plasma, Aspiration alone (Procedure) |
| Dates | start 2018-12-05, primary completion 2021-02-05, completion 2021-02-05, first posted 2018-01-24, last updated 2021-06-24 |
| Locations | 1 site in United Kingdom |
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All trials for Ganglion of Wrist All trials of Platelet rich plasma All trials of Aspiration alone
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.
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
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Aspiration alone | Active comparator | Procedure: Aspiration alone | The patients will have their dorsal wrist ganglion aspirated and then pressure dressing for 48 hours. |
| Aspiration plus platelet rich plasma | Experimental | Procedure: 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. |
Sex: All, ages: 16 Years to any
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.
| Milestone | Aspiration Alone | Aspiration Plus Platelet Rich Plasma |
|---|---|---|
| Started | 8 | 9 |
| Completed | 8 | 8 |
| Not completed | 0 | 1 |
Time frame: 1 year
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|---|---|---|
| Aspiration Alone | 0/8 (0.0%) | 0/8 (0.0%) | 0/8 (0.0%) |
| Aspiration Plus Platelet Rich Plasma | 0/9 (0.0%) | 0/9 (0.0%) | 0/9 (0.0%) |
| Facility | City | Country | Status |
|---|---|---|---|
| NHS Grampian | Aberdeen | United Kingdom |