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| Name | Class |
|---|---|
| NHS Grampian | OTHER_GOV |
| Arthrex, Inc. | INDUSTRY |
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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.
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
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aspiration alone | Active Comparator | The patients will have their dorsal wrist ganglion aspirated and then pressure dressing for 48 hours. |
|
| Aspiration plus platelet rich plasma | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet rich plasma | Procedure | Aspiration of ganglion and injection with platelet rich plasma. |
|
| 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katharine Hamlin, MBChB | NHS Grampian | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NHS Grampian | Aberdeen | AB25 2ZB | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Aspiration Alone | The patients will have their dorsal wrist ganglion aspirated and then pressure dressing for 48 hours. Aspiration alone: Aspiration of the ganglion |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aspiration Alone | The patients will have their dorsal wrist ganglion aspirated and then pressure dressing for 48 hours. Aspiration alone: Aspiration of the ganglion |
| BG001 | Aspiration Plus Platelet Rich Plasma |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With a Recurrence of Ganglia | Has the ganglion returned? | Posted | Count of Participants | Participants | 6 weeks |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aspiration Alone | The patients will have their dorsal wrist ganglion aspirated and then pressure dressing for 48 hours. Aspiration alone: Aspiration of the ganglion |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Miss Katharine Hamlin | NHS Grampian | 0845 456 6000 | 56755 | katharine.hamlin@nhs.scot |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 3, 2018 | Mar 25, 2021 | Prot_SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 3, 2018 | Jun 7, 2018 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D045888 | Ganglion Cysts |
| ID | Term |
|---|---|
| D003560 | Cysts |
| D009369 | Neoplasms |
| D017520 | Mucinoses |
| D003240 | Connective Tissue Diseases |
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Randomised controlled trial with two arms. Control - Aspiration alone. Intervention - aspiration plus injection of platelet righ plasma.
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The outcomes assessor will be blinded to the treatment received.
| Aspiration alone | Procedure | Aspiration of the ganglion |
|
| 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 |
| Background |
| 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. |
| 15085519 | Background | 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. |
| 15085518 | Background | 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. |
| 21244302 | Background | 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. |
| 23550739 | Background | 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. |
| 11813662 | Background | 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. |
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.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Number of Participants With a Recurrence of Ganglia | Has the ganglion returned? | Posted | Count of Participants | Participants | 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). | Posted | Mean | Full Range | score on a scale | 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). | Posted | Mean | Full Range | score on a scale | 12 months |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | 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. | 0 | 9 | 0 | 9 | 0 | 9 |
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| D017437 |
| Skin and Connective Tissue Diseases |