Arthroscopic Versus Open Excision of Dorsal Wrist Ganglion

April 14, 2024 updated by: Mohamed Abdelaal Sayed, Assiut University
compare recurrence rates after open and arthroscopic excision of dorsal wrist ganglion

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

DORSAL GANGLIONS (DGS) are one of the most frequent problems of the wrist. They represent benign soft tissue tumors that frequently remain asymptomatic. Suggested causes include trauma to the scapholunate joint, degeneration of tissue lining a tendon or sheath near the joint, and synovial herniation in most cases, diagnosis is based on history and physical examination. Patients seek treatment when these ganglions become associated with pain, weakness, interference with activities, and an increase in size Other than observation, nonoperative treatment such as closed rupture, ganglion puncture, and needle aspiration is associated with relatively higher rates of recurrenceas high as 78%. Surgical treatment with either open or arthroscopic excision is therefore offered with a lower risk of recurrence. Whereas open excision has historically been the traditional method of surgical treatment, arthroscopic excision has been suggested as a potentially more favorable alternative. Proponents of wrist arthroscopy proclaim an advantage of decreased postoperative pain, earlier return of functions, and a smaller incision. Moreover, preliminary and subsequent studies have described arthroscopic DG excision as having equal or lower rates of recurrence. However, the results of arthroscopic versus open procedures have never been directly compared.

Study Type

Interventional

Enrollment (Estimated)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 1. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: group 1
arthroscopic excision
Procedure: excision of dorsal wrist ganglion
open and arthroscopic excision of dorsal wrist ganglion
Other: group 2
open excision
Procedure: excision of dorsal wrist ganglion
open and arthroscopic excision of dorsal wrist ganglion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comparison of recurrence rate after open versus arthroscopic excision of dorsal wrist ganglion
Time Frame: one year
compare recurrence rate within one year after intervension
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
compare post operative pain ,range of motion ,hang grip strength and post operative scar after open versus arthroscopic excision of dorsal wrist ganglion
Time Frame: one year
compare post operative pain scaled from 1-10 (VAS score) range of wrist motion in degrees ( using goniometer ) hand grip strength in kilograms (using dynamometer)
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 2, 2024

Primary Completion (Estimated)

February 2, 2025

Study Completion (Estimated)

April 2, 2025

Study Registration Dates

First Submitted

January 13, 2024

First Submitted That Met QC Criteria

April 14, 2024

First Posted (Actual)

April 16, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 14, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dorsal wrist ganglion

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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