search
Back to results

Outcomes After Dorsal Wrist Ganglia Excision With or Without PIN

Primary Purpose

Wrist Ganglion, Ganglion Cysts, Hand Ganglion

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dorsal wrist ganglion alone (DWG)
DWG/PIN
Sponsored by
Kenneth Taylor, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wrist Ganglion focused on measuring ganglion cysts, dorsal wrist ganglia, neurectomy, denervation, posterior interosseous nerve

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Penn State Milton S. Hershey Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Dorsal wrist ganglion alone (DWG)

DWG with PIN

Arm Description

Dorsal wrist ganglion excision alone

Dorsal wrist ganglion excision with posterior interosseus neurectomy (PIN)

Outcomes

Primary Outcome Measures

Pain measured with the Visual Analog Pain Scale (VAS)
Self-report measurement that assesses a person's perceived level of pain
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
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.
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.

Secondary Outcome Measures

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
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.
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.
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.
Change in wrist flexion
This measurement indicates the range of motion of the wrist utilizing a goniometer
Change in wrist extension
This measurement indicates the range of motion of the wrist utilizing a goniometer
Change in wrist weight bearing extension
This measurement indicates the range of motion of the wrist utilizing a goniometer
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.
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.

Full Information

First Posted
May 24, 2021
Last Updated
August 15, 2023
Sponsor
Kenneth Taylor, M.D.
search

1. Study Identification

Unique Protocol Identification Number
NCT04932122
Brief Title
Outcomes After Dorsal Wrist Ganglia Excision With or Without PIN
Official Title
Outcomes of Surgical Excision of Dorsal Wrist Ganglia With or Without Partial Wrist Denervation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 7, 2023 (Actual)
Primary Completion Date
December 31, 2028 (Anticipated)
Study Completion Date
December 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kenneth Taylor, M.D.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wrist Ganglion, Ganglion Cysts, Hand Ganglion, Denervation Atrophy
Keywords
ganglion cysts, dorsal wrist ganglia, neurectomy, denervation, posterior interosseous nerve

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dorsal wrist ganglion alone (DWG)
Arm Type
Active Comparator
Arm Description
Dorsal wrist ganglion excision alone
Arm Title
DWG with PIN
Arm Type
Active Comparator
Arm Description
Dorsal wrist ganglion excision with posterior interosseus neurectomy (PIN)
Intervention Type
Procedure
Intervention Name(s)
Dorsal wrist ganglion alone (DWG)
Intervention Description
Patients assigned to this arm will undergo dorsal wrist ganglion cyst excision alone.
Intervention Type
Procedure
Intervention Name(s)
DWG/PIN
Intervention Description
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)..
Primary Outcome Measure Information:
Title
Pain measured with the Visual Analog Pain Scale (VAS)
Description
Self-report measurement that assesses a person's perceived level of pain
Time Frame
Preop to One Year Post-Op
Title
Physical Function measured with the Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH)
Description
11-Item questionnaire that measures physical function and symptoms in people with musculoskeletal disorders of the upper limb
Time Frame
Preop to One Year Post-Op
Title
Pain interference measured with the Patient-Reported Outcomes Measurement Information (PROMIS) Pain Interference instrument
Description
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.
Time Frame
Preop to One Year Post-Op
Title
Pain behavior measured with the Patient-Reported Outcomes Measurement Information (PROMIS) Pain Behavior instrument
Description
This instrument measures self-reported external manifestations of pain: behaviors that typically indicate to others that an individual is experiencing pain.
Time Frame
Preop to One Year Post-Op
Secondary Outcome Measure Information:
Title
Change in strength utilizing hand grip measurements
Description
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
Time Frame
Preop to 6 Months Post-Op
Title
Change in strength utilizing finger lateral pinch measurements
Description
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.
Time Frame
Preop to 6 Months Post-Op
Title
Change in strength utilizing finger tip pinch measurements
Description
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.
Time Frame
Preop to 6 Months Post-Op
Title
Change in strength utilizing finger three-point pinch measurements
Description
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.
Time Frame
Preop to 6 Months Post-Op
Title
Change in wrist flexion
Description
This measurement indicates the range of motion of the wrist utilizing a goniometer
Time Frame
Preop to 6 Months Post-Op
Title
Change in wrist extension
Description
This measurement indicates the range of motion of the wrist utilizing a goniometer
Time Frame
Preop to 6 Months Post-Op
Title
Change in wrist weight bearing extension
Description
This measurement indicates the range of motion of the wrist utilizing a goniometer
Time Frame
Preop to 6 Months Post-Op
Title
Change in wrist ulnar deviation
Description
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.
Time Frame
Preop to 6 Months Post-Op
Title
Change in wrist radial deviation
Description
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.
Time Frame
Preop to 6 Months Post-Op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Taylor, MD
Organizational Affiliation
Penn State Health Milton S Hershey Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11677666
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.
Results Reference
background
PubMed Identifier
10434077
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.
Results Reference
background
PubMed Identifier
1018091
Citation
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.
Results Reference
background
PubMed Identifier
3385297
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.
Results Reference
background
PubMed Identifier
681715
Citation
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.
Results Reference
background
PubMed Identifier
4078272
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.
Results Reference
background
PubMed Identifier
4020064
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.
Results Reference
background
PubMed Identifier
11301508
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.
Results Reference
background
PubMed Identifier
8515020
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.
Results Reference
background
PubMed Identifier
8773720
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.
Results Reference
background
PubMed Identifier
9708370
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.
Results Reference
background
PubMed Identifier
1593914
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.
Results Reference
background
PubMed Identifier
11721242
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.
Results Reference
background
PubMed Identifier
11103488
Citation
Gundes H, Cirpici Y, Sarlak A, Muezzinoglu S. Prognosis of wrist ganglion operations. Acta Orthop Belg. 2000 Oct;66(4):363-7.
Results Reference
background
PubMed Identifier
13806476
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.
Results Reference
background
PubMed Identifier
12809562
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.
Results Reference
background
PubMed Identifier
12239673
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.
Results Reference
background
Citation
Dell P. Benign, Aggressive, and Malignant Neoplasms. Hand Surgery Update, American Society for Surgery of the Hand, 1999, pg. 377.
Results Reference
background

Learn more about this trial

Outcomes After Dorsal Wrist Ganglia Excision With or Without PIN

We'll reach out to this number within 24 hrs