Clinical Trials Directory

Trials / Terminated

TerminatedNCT04932122

Outcomes After Dorsal Wrist Ganglia Excision With or Without PIN

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

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
3 (actual)
Sponsor
Kenneth Taylor, M.D. · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREDorsal wrist ganglion alone (DWG)Patients assigned to this arm will undergo dorsal wrist ganglion cyst excision alone.
PROCEDUREDWG/PINPatients 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)..

Timeline

Start date
2023-08-07
Primary completion
2026-02-03
Completion
2026-02-03
First posted
2021-06-18
Last updated
2026-02-11

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT04932122. Inclusion in this directory is not an endorsement.