NCT06366958

Brief Summary

compare recurrence rates after open and arthroscopic excision of dorsal wrist ganglion

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 16, 2024

Completed
16 days until next milestone

Study Start

First participant enrolled

May 2, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2025

Completed
Last Updated

April 16, 2024

Status Verified

April 1, 2024

Enrollment Period

9 months

First QC Date

January 13, 2024

Last Update Submit

April 14, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • comparison of recurrence rate after open versus arthroscopic excision of dorsal wrist ganglion

    compare recurrence rate within one year after intervension

    one year

Secondary Outcomes (1)

  • compare post operative pain ,range of motion ,hang grip strength and post operative scar after open versus arthroscopic excision of dorsal wrist ganglion

    one year

Study Arms (2)

group 1

OTHER

arthroscopic excision

Procedure: excision of dorsal wrist ganglion

group 2

OTHER

open excision

Procedure: excision of dorsal wrist ganglion

Interventions

open and arthroscopic excision of dorsal wrist ganglion

group 1group 2

Eligibility Criteria

Age10 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a primary, simple DG with no underlying pathology of the wrist who sought surgical treatment.

You may not qualify if:

  • \. Prior ganglion treatment (rupture, puncture, aspiration, or excision) 2. Previous surgery 3. History of a fracture 4. Ligamentous tear or wrist instability 5. Patients with major medical problems 6. Unacceptable anesthetic risks, 7. Acquired or congenital abnormalities of wrist function or motion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Meena S, Gupta A. Dorsal wrist ganglion: Current review of literature. J Clin Orthop Trauma. 2014 Jun;5(2):59-64. doi: 10.1016/j.jcot.2014.01.006. Epub 2014 Jun 3.

    PMID: 25983472BACKGROUND
  • Konigsberg MW, Tedesco LJ, Mueller JD, Ball JR, Wu CH, Kadiyala RK, Strauch RJ, Rosenwasser MP. Recurrence Rates of Dorsal Wrist Ganglion Cysts After Arthroscopic Versus Open Surgical Excision: A Retrospective Comparison. Hand (N Y). 2023 Jan;18(1):133-138. doi: 10.1177/15589447211003184. Epub 2021 Apr 1.

    PMID: 33789496BACKGROUND

Central Study Contacts

mohamed A sayed, master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident

Study Record Dates

First Submitted

January 13, 2024

First Posted

April 16, 2024

Study Start

May 2, 2024

Primary Completion

February 2, 2025

Study Completion

April 2, 2025

Last Updated

April 16, 2024

Record last verified: 2024-04