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Completed

NCT Number: NCT03408808

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

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NHS Grampian

Aberdeen, AB25 2ZB, United Kingdom

About this study

  • 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.
  • 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.

  • SOS/ Email/ Telephone interview - 1 (6 weeks)

a) Ganglion questionnaire b) PEM score c) Note any adverse events

  • SOS/ Email /Telephone interview - 2 (12 months)
  • Ganglion questionnaire
  • PEM score
  • Note any adverse events

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Platelet rich plasma

Procedure

Aspiration of ganglion and injection with platelet rich plasma.

Other names: PRP

Aspiration alone

Procedure

Aspiration of the ganglion

Primary outcomes

  1. Number of Participants With a Recurrence of Ganglia

    Time frame: 6 weeks

    Has the ganglion returned?

  2. Number of Participants With a Recurrence of Ganglia

    Time frame: 12 months

    Has the ganglion returned?

Secondary outcomes

  1. PEM Score

    Time frame: 6 weeks

    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).

  2. PEM Score

    Time frame: 12 months

    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).

Sponsors and collaborators

Lead sponsor

University of Aberdeen

Other

Collaborators

  • Arthrex, Inc.
  • NHS Grampian

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jan 24, 2018
Registry last updated
Jun 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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