Outcomes After Dorsal Wrist Ganglia Excision With or Without PIN

NCT04932122 | Terminated

• 1 other identifier: STUDY00016888
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

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.

Conditions

Wrist Ganglion; Ganglion Cysts; Hand Ganglion; Denervation Atrophy

Keywords

ganglion cysts; dorsal wrist ganglia; neurectomy; denervation; posterior interosseous nerve

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (9)

• Change in strength utilizing hand grip measurements

  Preop to 6 Months Post-Op

• Change in strength utilizing finger lateral pinch measurements

  Preop to 6 Months Post-Op

• Change in strength utilizing finger tip pinch measurements

  Preop to 6 Months Post-Op

• Change in strength utilizing finger three-point pinch measurements

  Preop to 6 Months Post-Op

• Change in wrist flexion

  Preop to 6 Months Post-Op

Study Arms (2)

Dorsal wrist ganglion alone (DWG)

ACTIVE COMPARATOR

Dorsal wrist ganglion excision alone

Procedure: Dorsal wrist ganglion alone (DWG)

DWG with PIN

ACTIVE COMPARATOR

Dorsal wrist ganglion excision with posterior interosseus neurectomy (PIN)

Procedure: DWG/PIN

Interventions

Dorsal wrist ganglion alone (DWG) PROCEDURE

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

Dorsal wrist ganglion alone (DWG)

DWG/PIN 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)..

DWG with PIN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kenneth Taylor, M.D.: lead

Study Sites (2)

Penn State Health Medical Group - Camp Hill Specialties

Camp Hill, Pennsylvania, 17011, United States

Location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (18)

• 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.

  PMID: 11677666 BACKGROUND

• 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.

  PMID: 10434077 BACKGROUND

• 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.

  PMID: 1018091 BACKGROUND

• 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.

  PMID: 3385297 BACKGROUND

• 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.

  PMID: 681715 BACKGROUND

• 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.

  PMID: 4078272 BACKGROUND

• 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.

  PMID: 4020064 BACKGROUND

• 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.

  PMID: 11301508 BACKGROUND

• 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.

  PMID: 8515020 BACKGROUND

• 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.

  PMID: 8773720 BACKGROUND

• 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.

  PMID: 9708370 BACKGROUND

• 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.

  PMID: 1593914 BACKGROUND

• Szabo RM. Outcomes assessment in hand surgery: when are they meaningful? J Hand Surg Am. 2001 Nov;26(6):993-1002. doi: 10.1053/jhsu.2001.29487.

  PMID: 11721242 BACKGROUND

• Gundes H, Cirpici Y, Sarlak A, Muezzinoglu S. Prognosis of wrist ganglion operations. Acta Orthop Belg. 2000 Oct;66(4):363-7.

  PMID: 11103488 BACKGROUND

• 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.

  PMID: 13806476 BACKGROUND

• 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.

  PMID: 12809562 BACKGROUND

• 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.

  PMID: 12239673 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Ganglion Cysts

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Mucinoses; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Kenneth Taylor, MD

  Penn State Health Milton S Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Orthopaedics and Rehabilitation

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: June 18, 2021
• Study Start: August 7, 2023
• Primary Completion: February 3, 2026
• Study Completion: February 3, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02

Locations

US (2)