Outcomes After Dorsal Wrist Ganglia Excision With or Without PIN (NCT04932122) | Clinical Trial Compass
TerminatedNot Applicable
Outcomes After Dorsal Wrist Ganglia Excision With or Without PIN
Stopped: Study recruitment stopped due to recruitment problems
United States3 participantsStarted 2023-08-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain measured with the Visual Analog Pain Scale (VAS)
Timeframe: Preop to One Year Post-Op
2
Physical Function measured with the Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH)
Timeframe: Preop to One Year Post-Op
3
Pain interference measured with the Patient-Reported Outcomes Measurement Information (PROMIS) Pain Interference instrument
Timeframe: Preop to One Year Post-Op
4
Pain behavior measured with the Patient-Reported Outcomes Measurement Information (PROMIS) Pain Behavior instrument