Outcomes After Dorsal Wrist Ganglia Excision With or Without PIN

Ganglion Cysts Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04932122
• Other study ID #: STUDY00016888
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 7, 2023
• Est. completion date: December 31, 2028

Study information

• Verified date: August 2023
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 32
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ganglion Cysts

Intervention

Procedure:
• Dorsal wrist ganglion alone (DWG)
Patients assigned to this arm will undergo dorsal wrist ganglion cyst excision alone.
• 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)..

Locations

Country	Name	City	State
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Kenneth Taylor, M.D.

Country where clinical trial is conducted

United States, 

References & Publications (18)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in wrist flexion	This measurement indicates the range of motion of the wrist utilizing a goniometer	Preop to 6 Months Post-Op
Secondary	Change in wrist extension	This measurement indicates the range of motion of the wrist utilizing a goniometer	Preop to 6 Months Post-Op
Secondary	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
Secondary	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
Secondary	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