An interventional study of Platelet rich plasma and Aspiration alone in Ganglion of Wrist, sponsored by University of Aberdeen. Completed at 1 site in United Kingdom. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2021-06-24.
Sponsored by University of Aberdeen · Not applicable, Interventional, and Treatment
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.
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
Intervention - clinic visit 1 or 2
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.
a) Ganglion questionnaire b) PEM score c) Note any adverse events
Exclusion Criteria:
The patients will have their dorsal wrist ganglion aspirated and then pressure dressing for 48 hours.
Procedure: Aspiration alone
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
Aspiration of ganglion and injection with platelet rich plasma.
Also known as: PRP
Aspiration of the ganglion
Number of Participants With a Recurrence of Ganglia
Has the ganglion returned?
Time frame: 6 weeks
Number of Participants With a Recurrence of Ganglia
Has the ganglion returned?
Time frame: 12 months
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).
Time frame: 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).
Time frame: 12 months
| Milestone | Aspiration Alone | Aspiration Plus Platelet Rich Plasma |
|---|---|---|
| Started | 8 | 9 |
| Completed | 8 | 8 |
| Not completed | 0 | 1 |
Has the ganglion returned?
| Participants | Aspiration Alone | Aspiration Plus Platelet Rich Plasma |
|---|---|---|
| Number of Participants With a Recurrence of Ganglia | 8 | 5 |
Has the ganglion returned?
| Participants | Aspiration Alone | Aspiration Plus Platelet Rich Plasma |
|---|---|---|
| Number of Participants With a Recurrence of Ganglia | 3 | 7 |
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).
| score on a scale | Aspiration Alone | Aspiration Plus Platelet Rich Plasma |
|---|---|---|
| PEM Score | 40.2 (27.8 to 58.6) | 38.7 (15.8 to 66.9) |
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).
| score on a scale | Aspiration Alone | Aspiration Plus Platelet Rich Plasma |
|---|---|---|
| PEM Score | 35 (14.3 to 66.2) | 40.6 (14.3 to 57.1) |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Aspiration Alone | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Aspiration Plus Platelet Rich Plasma | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Age, Continuous(years) | Aspiration Alone | Aspiration Plus Platelet Rich Plasma | Total |
|---|---|---|---|
| Mean | 33.9 (23 to 46) | 23.2 (18 to 29) | 28.6 (18 to 46) |
| Sex: Female, Male(Participants) | Aspiration Alone | Aspiration Plus Platelet Rich Plasma | Total |
|---|---|---|---|
| Female | 7 | 7 | 14 |
| Male | 1 | 2 | 3 |
| Race and Ethnicity Not Collected(Participants) | Aspiration Alone | Aspiration Plus Platelet Rich Plasma | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Aspiration Alone | Aspiration Plus Platelet Rich Plasma | Total |
|---|---|---|---|
| United Kingdom | 8 | 9 | 17 |
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University of Aberdeen