Hand GanglionNCT06366958
Arthroscopic Versus Open Excision of Dorsal Wrist Ganglion
A study testing excision of dorsal wrist ganglion in people with Hand Ganglion, run by Assiut University.
Trial summary
compare recurrence rates after open and arthroscopic excision of dorsal wrist ganglion Read more about this study
- Who is it for?
- Ages 10 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hand Ganglion
- What is being tested?
- excision of dorsal wrist ganglion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 2 May 2024to 2 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with a primary, simple DG with no underlying pathology of the wrist who sought surgical treatment.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
compare recurrence rates after open and arthroscopic excision of dorsal wrist ganglion
Read the 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.
- Conditions
- Hand Ganglion
- Being tested
- excision of dorsal wrist ganglion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
excision of dorsal wrist ganglionProcedure or surgery
open and arthroscopic excision of dorsal wrist ganglion
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Other | arthroscopic excision Receives: Procedure: excision of dorsal wrist ganglion |
| group 2 | Other | open excision Receives: Procedure: excision of dorsal wrist ganglion |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of recurrence rate after open versus arthroscopic excision of dorsal wrist ganglion
compare recurrence rate within one year after intervension
Measured: 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
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)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start2 May 2024 (estimated)
- Primary completion2 Feb 2025 (estimated)
- Study completion2 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hand GanglionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdelaal Sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06366958
- Sponsor's protocol ID
- Dorsal wrist ganglion
- Status last verified
- Apr 2024
- First submitted
- 13 Jan 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25983472Konigsberg 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.
PubMed 33789496
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Versus Open Excision of Dorsal Wrist Ganglion
- ClinicalTrials.gov ID
- NCT06366958
- Acronym / sponsor ID
- Dorsal wrist ganglion
- Conditions
- Hand Ganglion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 2 May 2024 (estimated)
- Primary completion
- 2 Feb 2025 (estimated)
- Study completion
- 2 Apr 2025 (estimated)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
compare recurrence rates after open and arthroscopic excision of dorsal wrist ganglion
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Other | Procedure: excision of dorsal wrist ganglionarthroscopic excision |
| group 2 | Other | Procedure: excision of dorsal wrist ganglionopen excision |
Who may qualify
- Ages
- 10 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with a primary, simple DG with no underlying pathology of the wrist who sought surgical treatment.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| excision of dorsal wrist ganglionopen and arthroscopic excision of dorsal wrist ganglion | Procedure or surgery | group 1, group 2 |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Background: PubMed 25983472Meena 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.
- Background: PubMed 33789496Konigsberg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing excision of dorsal wrist ganglion in people with Hand Ganglion, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mohamed A sayed, master (01097370350, mohamed.20134291@med.edu.aun.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of recurrence rate after open versus arthroscopic excision of dorsal wrist ganglion (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06366958, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.