Ganglion Resection Effectiveness Trial

NCT ID: NCT07162415

Last Updated: 2026-01-21

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-13

Study Completion Date

2035-12-31

Brief Summary

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The goal of this clinical trial is to learn if surgery helps with wrist ganglions in adults. The main question it aims to answer is:

* 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

Detailed Description

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Wrist ganglions are the most common soft tissue tumors of the hand and also the most frequently excised hand lesions. Despite their high prevalence, the best treatment remains uncertain, as earlier studies have provided conflicting evidence and randomized controlled data are scarce.

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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Wrist Ganglion Ganglion Ganglion Cyst Connective Tissue Disease Mucinoses

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The trial design is multicentre, randomized, parallel group (1:1) controlled, superiority trial.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Due to the nature of the interventions and inability to blind the participants with placebo surgery (as the visible mass would reveal the allocation after surgery), blinding is not possible. Since the outcomes are participant reported, we will not attempt to blind the investigator or other personnel.

Study Groups

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Surgery

Group Type EXPERIMENTAL

Open resection

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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

Group Type ACTIVE_COMPARATOR

Conservative treatment

Intervention Type OTHER

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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* wrist pain located in the ganglion area
* 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

* pregnant or breast feeding
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tampere University

OTHER

Sponsor Role collaborator

Hospital Nova of Central Finland

UNKNOWN

Sponsor Role collaborator

National University Hospital, Singapore

OTHER

Sponsor Role collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role collaborator

Tampere University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Helsinki University Hospital

Helsinki, , Finland

Site Status NOT_YET_RECRUITING

Hospital Nova of Central Finland

Jyväskylä, , Finland

Site Status NOT_YET_RECRUITING

Tampere University Hospital

Tampere, , Finland

Site Status RECRUITING

National University Hospital

Singapore, , Singapore

Site Status NOT_YET_RECRUITING

Countries

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Finland Singapore

Central Contacts

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Lasse Linnanmäki, MD, PhD

Role: CONTACT

+3583311611

Facility Contacts

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Panu H Nordback, MD, PhD

Role: primary

+35894711

Teemu Karjalainen, MD, PhD

Role: primary

+358142691811

Lasse Linnanmäki, MD, PhD

Role: primary

+358311611

Alphonsus KS Chong, MD, PhD

Role: primary

+6569082222

Other Identifiers

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R25038

Identifier Type: -

Identifier Source: org_study_id

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