Outcomes After Dorsal Wrist Ganglia Excision with or Without PIN

Kenneth Taylor, M.D.

Status: Invitation-only

Conditions: Wrist Ganglion; Hand Ganglion; Ganglion Cysts; Denervation Atrophy

Treatments: Procedure: Dorsal wrist ganglion alone (DWG); Procedure: DWG/PIN

Study type: Interventional

Funder types: Other

Identifiers

NCT04932122

STUDY00016888

Details and patient eligibility

About

The purpose of this study is to determine if a statistical significance exists between outcomes of patients treated for dorsal wrist ganglion cyst with excision alone versus excision and the addition of a partial wrist denervation by resecting the common terminal sensory branch of the PIN (posterior interosseus nerve). Our hypothesis is that addition of PIN improves outcome after dorsal wrist ganglion excision as indicated by post-operative pain, function, ability to perform activities of daily living, and physical exam findings.

Full description

The primary endpoint will be outcomes on subject surveys and questionnaires. Data will be collected pre- and post-operatively at 2 weeks, 12 weeks, 6 months, and one year. Four questionnaires will be used, including the Visual Analog Pain Score (VAS), Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaire, as well as the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (PI), and the PROMIS Pain Behavior (PB) questionnaires.

Secondary outcomes include physical examination consisting of pre- and post-operative pinch and grip strength testing, and active range of motion including wrist flexion and extension ulnar and radial deviation, and weight bearing extension. These will be performed at 2 weeks, 12 weeks, and 6 months post-operatively.

Enrollment: 32 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Greater than or equal to 18 years of age
• Gender: male/female (non-pregnant)
• Diagnosis of symptomatic (pain and limited ability to perform activities of daily living) dorsal wrist ganglion cyst
• Subjects who have chosen surgical management for their ganglion cyst diagnosis
• Fluent in written and spoken English
• Subject is able to provide voluntary, written informed consent
• Subject, in the opinion of the clinical investigator, is able to understand the clinical investigation and is willing to perform all study procedures and follow-up visits
• Non-Prisoners

Exclusion criteria

• Less than 18 years of age
• Non-elective surgery for this diagnosis
• Chronic wrist instability of the operative extremity
• Comorbid neurologic maladies of the operative extremity
• Prior wrist surgery on either extremity
• Non-English speaking
• Prisoners
• Pregnancy
• Cognitive Impairment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups

Dorsal wrist ganglion alone (DWG)

Active Comparator group

Description:

Dorsal wrist ganglion excision alone

Treatment:

Procedure: Dorsal wrist ganglion alone (DWG)

DWG with PIN

Active Comparator group

Description:

Dorsal wrist ganglion excision with posterior interosseus neurectomy (PIN)

Treatment:

Procedure: DWG/PIN