Clinical trial NCT04932122: Outcomes After Dorsal Wrist Ganglia Excision With or Without PIN
Official title: Outcomes of Surgical Excision of Dorsal Wrist Ganglia With or Without Partial Wrist Denervation
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Wrist Ganglion
Ganglion Cysts
Hand Ganglion
Denervation Atrophy
Keywords: ganglion cysts
dorsal wrist ganglia
neurectomy
denervation
posterior interosseous nerve
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain measured with the Visual Analog Pain Scale (VAS)
timeFrame: Preop to One Year Post-Op
measure: Physical Function measured with the Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH)
timeFrame: Preop to One Year Post-Op
measure: Pain interference measured with the Patient-Reported Outcomes Measurement Information (PROMIS) Pain Interference instrument
timeFrame: Preop to One Year Post-Op
measure: Pain behavior measured with the Patient-Reported Outcomes Measurement Information (PROMIS) Pain Behavior instrument
timeFrame: Preop to One Year Post-Op
Secondary outcomes:
measure: Change in strength utilizing hand grip measurements
timeFrame: Preop to 6 Months Post-Op
measure: Change in strength utilizing finger lateral pinch measurements
timeFrame: Preop to 6 Months Post-Op
measure: Change in strength utilizing finger tip pinch measurements
timeFrame: Preop to 6 Months Post-Op
measure: Change in strength utilizing finger three-point pinch measurements
timeFrame: Preop to 6 Months Post-Op
measure: Change in wrist flexion
timeFrame: Preop to 6 Months Post-Op
measure: Change in wrist extension
timeFrame: Preop to 6 Months Post-Op
measure: Change in wrist weight bearing extension
timeFrame: Preop to 6 Months Post-Op
measure: Change in wrist ulnar deviation
timeFrame: Preop to 6 Months Post-Op
measure: Change in wrist radial deviation
timeFrame: Preop to 6 Months Post-Op
Other outcomes:
Locations:
city: Camp Hill
country: United States
facility: Penn State Health Medical Group - Camp Hill Specialties
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Penn State Health Milton S Hershey Medical Center
name: Kenneth Taylor, MD
role: PRINCIPAL_INVESTIGATOR
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