Outcomes After Dorsal Wrist Ganglia Excision With or Without PIN

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Ganglion Cysts; Wrist Ganglion; Hand Ganglion; Denervation Atrophy
• Intervention / Treatment: Procedure: Dorsal wrist ganglion alone (DWG); Procedure: DWG/PIN

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.

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S. Hershey Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Kenneth Taylor, M.D.
• Investigators: Principal Investigator: Kenneth Taylor, MD, Penn State Health Milton S. Hershey Medical Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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. Erratum In: Am J Ind Med 1996 Sep;30(3):372.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Gundes H, Cirpici Y, Sarlak A, Muezzinoglu S. Prognosis of wrist ganglion operations. Acta Orthop Belg. 2000 Oct;66(4):363-7.
• 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.
• 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.
• Dell P. Benign, Aggressive, and Malignant Neoplasms. Hand Surgery Update, American Society for Surgery of the Hand, 1999, pg. 377.

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: May 24, 2021
• First Submitted That Met QC Criteria: June 17, 2021
• First Posted (Actual): June 18, 2021

Study Record Updates

• Last Update Posted (Actual): August 18, 2023
• Last Update Submitted That Met QC Criteria: August 15, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: denervation; neurectomy; ganglion cysts; dorsal wrist ganglia; posterior interosseous nerve
• Additional Relevant MeSH Terms: Neoplasms; Cysts; Connective Tissue Diseases; Mucinoses; Ganglion Cysts; Synovial Cyst
• Other Study ID Numbers: STUDY00016888

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No