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Outcomes After Dorsal Wrist Ganglia Excision With or Without PIN

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ClinicalTrials.gov Identifier: NCT04932122
Recruitment Status : Enrolling by invitation
First Posted : June 18, 2021
Last Update Posted : August 31, 2021
Sponsor:
Information provided by (Responsible Party):
Kenneth Taylor, M.D., Milton S. Hershey Medical Center

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.

Condition or disease Intervention/treatment Phase
Wrist Ganglion Ganglion Cysts Hand Ganglion Denervation Atrophy Procedure: Dorsal wrist ganglion alone (DWG) Procedure: DWG/PIN Not Applicable

Detailed Description:

The primary endpoint will be outcomes on subject surveys and questionnaires. Data will be collected pre-operatively and post-operatively at 2 weeks, 1 month, 2 months, 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 PROMIS PI (Pain Interference), and the PROMIS PB (Pain Behavior) questionnaires.

Secondary outcomes include physical examination consisting of pre- and post-operative range of motion, pinch, and grip strength testing.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes 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.
Primary Purpose: Treatment
Official Title: Outcomes of Surgical Excision of Dorsal Wrist Ganglia With or Without Partial Wrist Denervation
Actual Study Start Date : August 24, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

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)..




Primary Outcome Measures :
  1. Pain measured with the Visual Analog Pain Scale (VAS) [ Time Frame: Preop to One Year Post-Op ]
    Self-report measurement that assesses a person's perceived level of pain

  2. Physical Function measured with the Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH) [ Time Frame: Preop to One Year Post-Op ]
    11-Item questionnaire that measures physical function and symptoms in people with musculoskeletal disorders of the upper limb

  3. Pain interference measured with the Patient-Reported Outcomes Measurement Information (PROMIS) Pain Interference instrument [ Time Frame: Preop to One Year Post-Op ]
    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.

  4. Pain behavior measured with the Patient-Reported Outcomes Measurement Information (PROMIS) Pain Behavior instrument [ Time Frame: Preop to One Year Post-Op ]
    This instrument measures self-reported external manifestations of pain: behaviors that typically indicate to others that an individual is experiencing pain.


Secondary Outcome Measures :
  1. Change in strength utilizing hand grip measurements [ Time Frame: Preop to One Year Post-Op ]
    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

  2. Change in strength utilizing finger lateral pinch measurements [ Time Frame: Preop to One Year Post-Op ]
    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.

  3. Change in strength utilizing finger tip pinch measurements [ Time Frame: Preop to One Year Post-Op ]
    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.

  4. Change in strength utilizing finger three-point pinch measurements [ Time Frame: Preop to One Year Post-Op ]
    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.

  5. Change in wrist flexion [ Time Frame: Preop to One Year Post-Op ]
    This measurement indicates the range of motion of the wrist utilizing a goniometer

  6. Change in wrist extension [ Time Frame: Preop to One Year Post-Op ]
    This measurement indicates the range of motion of the wrist utilizing a goniometer

  7. Change in wrist weight bearing extension [ Time Frame: Preop to One Year Post-Op ]
    This measurement indicates the range of motion of the wrist utilizing a goniometer

  8. Change in wrist ulnar deviation [ Time Frame: Preop to One Year Post-Op ]
    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.

  9. Change in wrist radial deviation [ Time Frame: Preop to One Year Post-Op ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04932122


Locations
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United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Kenneth Taylor, M.D.
Investigators
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Principal Investigator: Kenneth Taylor, MD Penn State Health Milton S. Hershey Medical Center
Publications:
Dell P. Benign, Aggressive, and Malignant Neoplasms. Hand Surgery Update, American Society for Surgery of the Hand, 1999, pg. 377.

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Responsible Party: Kenneth Taylor, M.D., Professor of Orthopaedics and Rehabilitation, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT04932122    
Other Study ID Numbers: STUDY00016888
First Posted: June 18, 2021    Key Record Dates
Last Update Posted: August 31, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kenneth Taylor, M.D., Milton S. Hershey Medical Center:
ganglion cysts
dorsal wrist ganglia
neurectomy
denervation
posterior interosseous nerve
Additional relevant MeSH terms:
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Ganglion Cysts
Synovial Cyst
Atrophy
Pathological Conditions, Anatomical
Cysts
Neoplasms
Mucinoses
Connective Tissue Diseases