Outcomes After Dorsal Wrist Ganglia Excision With or Without PIN

NCT ID: NCT04932122

Last Updated: 2026-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-07

Study Completion Date

2026-02-03

Brief Summary

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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

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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

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Wrist Ganglion Ganglion Cysts Hand Ganglion Denervation Atrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The patient and the study team member who is performing the physical exam (including range of motion and grip/pinch strength testing) will be blinded to the randomization.

Study Groups

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Dorsal wrist ganglion alone (DWG)

Dorsal wrist ganglion excision alone

Group Type ACTIVE_COMPARATOR

Dorsal wrist ganglion alone (DWG)

Intervention Type PROCEDURE

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

DWG with PIN

Dorsal wrist ganglion excision with posterior interosseus neurectomy (PIN)

Group Type ACTIVE_COMPARATOR

DWG/PIN

Intervention Type PROCEDURE

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)..

Interventions

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Dorsal wrist ganglion alone (DWG)

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

Intervention Type PROCEDURE

DWG/PIN

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)..

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kenneth Taylor, M.D.

OTHER

Sponsor Role lead

Responsible Party

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Kenneth Taylor, M.D.

Professor of Orthopaedics and Rehabilitation

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Kenneth Taylor, MD

Role: PRINCIPAL_INVESTIGATOR

Penn State Health Milton S Hershey Medical Center

Locations

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Penn State Health Medical Group - Camp Hill Specialties

Camp Hill, Pennsylvania, United States

Site Status

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Countries

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United States

References

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Carr D, Davis P. Distal posterior interosseous nerve syndrome. J Hand Surg Am. 1985 Nov;10(6 Pt 1):873-8. doi: 10.1016/s0363-5023(85)80165-9.

Reference Type BACKGROUND
PMID: 4078272 (View on PubMed)

Dellon AL. Partial dorsal wrist denervation: resection of the distal posterior interosseous nerve. J Hand Surg Am. 1985 Jul;10(4):527-33. doi: 10.1016/s0363-5023(85)80077-0.

Reference Type BACKGROUND
PMID: 4020064 (View on PubMed)

Faithfull DK, Seeto BG. The simple wrist ganglion--more than a minor surgical procedure? Hand Surg. 2000 Dec;5(2):139-43. doi: 10.1142/s0218810400000235.

Reference Type BACKGROUND
PMID: 11301508 (View on PubMed)

Fukumoto K, Kojima T, Kinoshita Y, Koda M. An anatomic study of the innervation of the wrist joint and Wilhelm's technique for denervation. J Hand Surg Am. 1993 May;18(3):484-9. doi: 10.1016/0363-5023(93)90096-L.

Reference Type BACKGROUND
PMID: 8515020 (View on PubMed)

Clay NR, Clement DA. The treatment of dorsal wrist ganglia by radical excision. J Hand Surg Br. 1988 May;13(2):187-91. doi: 10.1016/0266-7681_88_90135-0.

Reference Type BACKGROUND
PMID: 3385297 (View on PubMed)

Dellon AL, Seif SS. Anatomic dissections relating the posterior interosseous nerve to the carpus, and the etiology of dorsal wrist ganglion pain. J Hand Surg Am. 1978 Jul;3(4):326-32. doi: 10.1016/s0363-5023(78)80032-x.

Reference Type BACKGROUND
PMID: 681715 (View on PubMed)

Ho PC, Griffiths J, Lo WN, Yen CH, Hung LK. Current treatment of ganglion of the wrist. Hand Surg. 2001 Jul;6(1):49-58. doi: 10.1142/s0218810401000540.

Reference Type BACKGROUND
PMID: 11677666 (View on PubMed)

Thornburg LE. Ganglions of the hand and wrist. J Am Acad Orthop Surg. 1999 Jul-Aug;7(4):231-8. doi: 10.5435/00124635-199907000-00003.

Reference Type BACKGROUND
PMID: 10434077 (View on PubMed)

Angelides AC, Wallace PF. The dorsal ganglion of the wrist: its pathogenesis, gross and microscopic anatomy, and surgical treatment. J Hand Surg Am. 1976 Nov;1(3):228-35. doi: 10.1016/s0363-5023(76)80042-1.

Reference Type BACKGROUND
PMID: 1018091 (View on PubMed)

Hudak PL, Amadio PC, Bombardier C. Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG). Am J Ind Med. 1996 Jun;29(6):602-8. doi: 10.1002/(SICI)1097-0274(199606)29:63.0.CO;2-L.

Reference Type BACKGROUND
PMID: 8773720 (View on PubMed)

Chung KC, Pillsbury MS, Walters MR, Hayward RA. Reliability and validity testing of the Michigan Hand Outcomes Questionnaire. J Hand Surg Am. 1998 Jul;23(4):575-87. doi: 10.1016/S0363-5023(98)80042-7.

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Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.

Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
PMID: 11103488 (View on PubMed)

BUTLER ED, HAMILL JP, SEIPEL RS, DE LORIMIER AA. Tumors of the hand. A ten-year survey and report of 437 cases. Am J Surg. 1960 Aug;100:293-302. doi: 10.1016/0002-9610(60)90302-0. No abstract available.

Reference Type BACKGROUND
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Gummesson C, Atroshi I, Ekdahl C. The disabilities of the arm, shoulder and hand (DASH) outcome questionnaire: longitudinal construct validity and measuring self-rated health change after surgery. BMC Musculoskelet Disord. 2003 Jun 16;4:11. doi: 10.1186/1471-2474-4-11. Epub 2003 Jun 16.

Reference Type BACKGROUND
PMID: 12809562 (View on PubMed)

Weinstein LP, Berger RA. Analgesic benefit, functional outcome, and patient satisfaction after partial wrist denervation. J Hand Surg Am. 2002 Sep;27(5):833-9. doi: 10.1053/jhsu.2002.35302.

Reference Type BACKGROUND
PMID: 12239673 (View on PubMed)

Dell P. Benign, Aggressive, and Malignant Neoplasms. Hand Surgery Update, American Society for Surgery of the Hand, 1999, pg. 377.

Reference Type BACKGROUND

Other Identifiers

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STUDY00016888

Identifier Type: -

Identifier Source: org_study_id

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