Outcomes After Dorsal Wrist Ganglia Excision With or Without PIN

Kenneth Taylor, M.D.3 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Wrist Ganglion

Interventions

Dorsal wrist ganglion alone (DWG)PROCEDURE

Patients assigned to this arm will undergo dorsal wrist ganglion cyst excision alone.

DWG/PINPROCEDURE

Patients assigned to this arm will undergo dorsal wrist ganglion excision and the addition of a partial wrist denervation by resecting the common terminal sensory branch of the posterior interosseus nerve (PIN)..

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Pain measured with the Visual Analog Pain Scale (VAS)

Self-report measurement that assesses a person's perceived level of pain

Time frame: Preop to One Year Post-Op

Physical Function measured with the Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH)

11-Item questionnaire that measures physical function and symptoms in people with musculoskeletal disorders of the upper limb

Time frame: Preop to One Year Post-Op

Pain interference measured with the Patient-Reported Outcomes Measurement Information (PROMIS) Pain Interference instrument

This instrument measures the self-reported consequences of pain on relevant aspects of one's life and may include the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities.

Time frame: Preop to One Year Post-Op

Pain behavior measured with the Patient-Reported Outcomes Measurement Information (PROMIS) Pain Behavior instrument

This instrument measures self-reported external manifestations of pain: behaviors that typically indicate to others that an individual is experiencing pain.

Time frame: Preop to One Year Post-Op

Secondary Outcomes

Change in strength utilizing hand grip measurements

This measurement provides information about muscle strength health in the hand and forearms. The average of three measurements is taken using a hand-held dynamometer