Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
220 participants
INTERVENTIONAL
2026-01-13
2035-12-31
Brief Summary
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* Does surgery result in better patient-reported outcomes and satisfaction over a 6-months follow-up period?
Researchers will compare surgery to conservative treatment (self-administered exercises and use of the hand as tolerated) to see if surgery provides superior outcomes.
Participants will:
* Be randomly assigned to receive either surgery or conservative treatment
* Complete questionnaires about wrist pain, function, quality of life, satisfaction, and recovery at 3, 6, and 12 months
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Detailed Description
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This study is a multicenter, randomized, controlled, superiority trial comparing surgical excision with conservative care in adults with a painful wrist ganglion. The trial is conducted in Finland and Singapore, with participants randomized in equal groups. Follow-up continues for 12 months, with primary evaluation at 6 months.
The study protocol has been reviewed and approved by the regional ethics committee. Written informed consent will be obtained from all participants prior to enrollment. Results will be published in peer-reviewed journals and presented at scientific meetings to inform clinical decision-making for patients with wrist ganglions.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Surgery
Open resection
A transverse or longitudinal incision is done depending on surgeon's preference. The ganglion and its pedicle are traced up to its origin. The pedicle is resected tangentially, usually, from the SL ligament for dorsal ganglions and depending on the site for volar ganglion. Wrist capsule is not closed.
Arthroscopic resection
Portals are selected by surgeon's preference. The pedicle of the ganglion is located and resected with a shaver. It is not necessary to remove all the ganglion walls. The portal incisions do not need to be sutured.
Conservative treatment
Conservative treatment
Participant will be informed about the natural course of wrist ganglions. The conservative treatment may include needle aspiration of the ganglion, but it is not performed routinely. Participants are informed that wrist loading in extension may exacerbate the pain, and that the pain is not a sign of further injury to wrist joint. They can avoid heavy use it if they have too much pain, but they are advised to use hand as tolerated. Participants may use NSAIDs and acetaminophen for pain management as needed; however, the protocol does not specify a required course or dosage. A simple self-implemented exercise therapy instructions are given to every participant.
Interventions
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Open resection
A transverse or longitudinal incision is done depending on surgeon's preference. The ganglion and its pedicle are traced up to its origin. The pedicle is resected tangentially, usually, from the SL ligament for dorsal ganglions and depending on the site for volar ganglion. Wrist capsule is not closed.
Arthroscopic resection
Portals are selected by surgeon's preference. The pedicle of the ganglion is located and resected with a shaver. It is not necessary to remove all the ganglion walls. The portal incisions do not need to be sutured.
Conservative treatment
Participant will be informed about the natural course of wrist ganglions. The conservative treatment may include needle aspiration of the ganglion, but it is not performed routinely. Participants are informed that wrist loading in extension may exacerbate the pain, and that the pain is not a sign of further injury to wrist joint. They can avoid heavy use it if they have too much pain, but they are advised to use hand as tolerated. Participants may use NSAIDs and acetaminophen for pain management as needed; however, the protocol does not specify a required course or dosage. A simple self-implemented exercise therapy instructions are given to every participant.
Eligibility Criteria
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Inclusion Criteria
* diagnosis of ganglion of the wrist, based on clinical examination or imaging findings
* age over 18 years
* ability to fill out the Finnish or English version of the questionnaires
Exclusion Criteria
* other known wrist pathology that likely explains the pain
* previous surgical treatments of the wrist
* wrist ganglion presumed to be related to a work injury
18 Years
ALL
No
Sponsors
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Tampere University
OTHER
Hospital Nova of Central Finland
UNKNOWN
National University Hospital, Singapore
OTHER
Helsinki University Central Hospital
OTHER
Tampere University Hospital
OTHER
Responsible Party
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Locations
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Helsinki University Hospital
Helsinki, , Finland
Hospital Nova of Central Finland
Jyväskylä, , Finland
Tampere University Hospital
Tampere, , Finland
National University Hospital
Singapore, , Singapore
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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R25038
Identifier Type: -
Identifier Source: org_study_id
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