Outcomes After Dorsal Wrist Ganglia Excision With or Without PIN

Study Overview
=================
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.

Official Title
-----------------
Outcomes of Surgical Excision of Dorsal Wrist Ganglia With or Without Partial Wrist Denervation

Conditions
-----------------
Wrist Ganglion, Ganglion Cysts, Hand Ganglion, Denervation Atrophy

Intervention / Treatment
-----------------
* Procedure: Dorsal wrist ganglion alone (DWG)
* Procedure: DWG/PIN


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dorsal wrist ganglion alone (DWG)<br>Dorsal wrist ganglion excision alone | Procedure: Dorsal wrist ganglion alone (DWG)<br>* Patients assigned to this arm will undergo dorsal wrist ganglion cyst excision alone.<br>|
| Active Comparator: DWG with PIN<br>Dorsal wrist ganglion excision with posterior interosseus neurectomy (PIN) | Procedure: DWG/PIN<br>* 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)..<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain measured with the Visual Analog Pain Scale (VAS) | Self-report measurement that assesses a person's perceived level of pain | 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 | 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. | 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. | Preop to One Year Post-Op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Preop to 6 Months Post-Op | 
| Change in strength utilizing finger lateral pinch measurements | This measurement provides information about the functional strength of one's pinching action of the hand using a mechanical pinch gauge. The average of three measurements will be taken at each time frame. | Preop to 6 Months Post-Op | 
| Change in strength utilizing finger tip pinch measurements | This measurement provides information about the functional strength of one's pinching action of the hand using a mechanical pinch gauge. The average of three measurements will be taken at each time frame. | Preop to 6 Months Post-Op | 
| Change in strength utilizing finger three-point pinch measurements | This measurement provides information about the functional strength of one's pinching action of the hand using a mechanical pinch gauge. The average of three measurements will be taken at each time frame. | Preop to 6 Months Post-Op | 
| Change in wrist flexion | This measurement indicates the range of motion of the wrist utilizing a goniometer | Preop to 6 Months Post-Op | 
| Change in wrist extension | This measurement indicates the range of motion of the wrist utilizing a goniometer | Preop to 6 Months Post-Op | 
| Change in wrist weight bearing extension | This measurement indicates the range of motion of the wrist utilizing a goniometer | Preop to 6 Months Post-Op | 
| Change in wrist ulnar deviation | This measurement indicates the range of motion of the wrist from side to side. This movement flexes the hand toward the ulnar bone in the arm. This is measured with a goniometer. | Preop to 6 Months Post-Op | 
| Change in wrist radial deviation | This measurement indicates the range of motion of the wrist from side to side. This movement flexes the hand toward the radial bone in the arm. This is measured with a goniometer. | Preop to 6 Months Post-Op | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ganglion cysts, dorsal wrist ganglia, neurectomy, denervation, posterior interosseous nerve