Trial Outcomes & Findings for Dorsal Wrist Ganglia; Aspiration Alone vs Aspiration and Injection of Platelet Rich Plasma (NCT NCT03408808)

Results Overview

Has the ganglion returned?

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

17 participants

Primary outcome timeframe

6 weeks

Results posted on

2021-06-24

Participant Flow

Participant milestones

Participant milestones
Measure	Aspiration Alone The patients will have their dorsal wrist ganglion aspirated and then pressure dressing for 48 hours. Aspiration alone: Aspiration of the ganglion	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.
Overall Study STARTED	8	9
Overall Study COMPLETED	8	8
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aspiration Alone n=8 Participants The patients will have their dorsal wrist ganglion aspirated and then pressure dressing for 48 hours. Aspiration alone: Aspiration of the ganglion	Aspiration Plus Platelet Rich Plasma n=9 Participants 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.	Total n=17 Participants Total of all reporting groups
Age, Continuous	33.9 years n=8 Participants	23.2 years n=9 Participants	28.6 years n=17 Participants
Sex: Female, Male Female	7 Participants n=8 Participants	7 Participants n=9 Participants	14 Participants n=17 Participants
Sex: Female, Male Male	1 Participants n=8 Participants	2 Participants n=9 Participants	3 Participants n=17 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	8 participants n=8 Participants	9 participants n=9 Participants	17 participants n=17 Participants

PRIMARY outcome

Timeframe: 6 weeks

Has the ganglion returned?

Outcome measures

Outcome measures
Measure	Aspiration Alone n=8 Participants The patients will have their dorsal wrist ganglion aspirated and then pressure dressing for 48 hours. Aspiration alone: Aspiration of the ganglion	Aspiration Plus Platelet Rich Plasma n=8 Participants 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.
Number of Participants With a Recurrence of Ganglia	8 Participants	5 Participants

PRIMARY outcome

Timeframe: 12 months

Has the ganglion returned?

Outcome measures

Outcome measures
Measure	Aspiration Alone n=8 Participants The patients will have their dorsal wrist ganglion aspirated and then pressure dressing for 48 hours. Aspiration alone: Aspiration of the ganglion	Aspiration Plus Platelet Rich Plasma n=8 Participants 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.
Number of Participants With a Recurrence of Ganglia	3 Participants	7 Participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Aspiration Alone n=8 Participants The patients will have their dorsal wrist ganglion aspirated and then pressure dressing for 48 hours. Aspiration alone: Aspiration of the ganglion	Aspiration Plus Platelet Rich Plasma n=8 Participants 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.
PEM Score	40.2 score on a scale Interval 27.8 to 58.6	38.7 score on a scale Interval 15.8 to 66.9

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Aspiration Alone n=8 Participants The patients will have their dorsal wrist ganglion aspirated and then pressure dressing for 48 hours. Aspiration alone: Aspiration of the ganglion	Aspiration Plus Platelet Rich Plasma n=8 Participants 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.
PEM Score	35 score on a scale Interval 14.3 to 66.2	40.6 score on a scale Interval 14.3 to 57.1

Adverse Events

Aspiration Alone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Aspiration Plus Platelet Rich Plasma

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Miss Katharine Hamlin

NHS Grampian

Phone: 0845 456 6000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place