Dorsal Wrist Ganglia; Aspiration Alone vs Aspiration and Injection of Platelet Rich Plasma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Number of Participants With a Recurrence of Ganglia
研究概览
简要总结
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.
详细描述
- 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
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All patients assessed by the chief investigator Mr David Lawrie (DFML) or Miss Katharine Hamlin (KH).
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Clinical assessment of presence of ganglion.
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Ensure not meeting exclusion criteria.
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If eligible and willing to complete study commitments discuss study and answer questions.
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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.
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If they are willing to participate they will then be offered treatment in the same visit or a return visit
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Intervention - clinic visit 1 or 2
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Check understanding and continuing desire to participate in study if 2nd visit.
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Complete consent form.
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Patient fills out a PEM score and demographics collected on SOS (Surgical Outcomes System - Arthrex).
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Randomisation.
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If in PRP group 15ml blood sample taken with Arthrex ACP double syringe and processed (see processing instructions in Appendix.9.
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Aspiration.
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If in PRP group - Injection of PRP (the same volume as aspirated).
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Pressure dressing with gauze, wool and crepe for 48 hours.
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Adverse event screening/ management Patients are offered two options at the treatment visit.
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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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcomes assessor will be blinded to the treatment received.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Solitary dorsal wrist ganglion.
排除标准
- •Underlying wrist or ipsilateral arm pathology.
- •Unable to consent to treatment.
- •Unable or unwilling to attend follow up visits.
研究组 & 干预措施
Aspiration alone
The patients will have their dorsal wrist ganglion aspirated and then pressure dressing for 48 hours.
干预措施: Aspiration alone (Procedure)
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.
干预措施: Platelet rich plasma (Procedure)
结局指标
主要结局
Number of Participants With a Recurrence of Ganglia
时间窗: 12 months
Has the ganglion returned?
Number of Participants With a Recurrence of Ganglia
时间窗: 6 weeks
Has the ganglion returned?
次要结局
- PEM Score(12 months)
- PEM Score(6 weeks)