NCT03408808

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

Completed NA Results posted Last updated 24 June 2021

What this trial tests

NA trial testing Platelet rich plasma in Ganglion of Wrist in 17 participants. Completed in 5 February 2021.

Timeline

5 December 2018

Primary endpoint
5 February 2021

5 February 2021

Quick facts

Lead sponsor	University of Aberdeen
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	17
Start date	5 December 2018
Primary completion	5 February 2021
Estimated completion	5 February 2021
Sites	1 location across United Kingdom

Drugs / interventions tested

• Platelet rich plasma — full drug profile →
• Aspiration alone

Conditions studied

• Ganglion of Wrist — all drugs for Ganglion of Wrist →

Sponsor

University of Aberdeen

Who can join

16 and older, any sex, with Ganglion of Wrist. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With a Recurrence of Ganglia Primary · 6 weeks

Has the ganglion returned?

Group	Value	95% CI
Aspiration Alone	8
Aspiration Plus Platelet Rich Plasma	5

Number of Participants With a Recurrence of Ganglia Primary · 12 months

Has the ganglion returned?

Group	Value	95% CI
Aspiration Alone	3
Aspiration Plus Platelet Rich Plasma	7

PEM Score Secondary · 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 question

Group	Value	95% CI
Aspiration Alone	40.2	27.8 – 58.6
Aspiration Plus Platelet Rich Plasma	38.7	15.8 – 66.9

PEM Score Secondary · 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 question

Group	Value	95% CI
Aspiration Alone	35	14.3 – 66.2
Aspiration Plus Platelet Rich Plasma	40.6	14.3 – 57.1

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Dorsal Wrist Ganglion: Pilot for Randomized Control Trial Comparing Aspiration Alone or Combined with Injection of Platelet-Rich Plasma.
   Hamlin K, Haddon A, Khan Y, Miller C, et al · · 2023 · cited 1× · PMID 36644732 · DOI 10.1055/s-0042-1744367