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

June 1, 2021 updated by: University of Aberdeen

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Aspiration alone
The patients will have their dorsal wrist ganglion aspirated and then pressure dressing for 48 hours.
Procedure: Aspiration alone
Aspiration of the ganglion
Experimental: 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.
Procedure: Platelet rich plasma
Aspiration of ganglion and injection with platelet rich plasma.
Other Names:
  • PRP

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With a Recurrence of Ganglia
Time Frame: 6 weeks
Has the ganglion returned?
6 weeks
Number of Participants With a Recurrence of Ganglia
Time Frame: 12 months
Has the ganglion returned?
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
6 weeks
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).
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Aberdeen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Arthrex, Inc.
NHS Grampian

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Katharine Hamlin, MBChB, NHS Grampian

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 5, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 5, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 5, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 16, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 24, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1/091/17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Drug Interventions

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