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Wrist GanglionGangLionNCT07162415

Ganglion Resection Effectiveness Trial

A study testing Open resection, Arthroscopic resection and Conservative treatment in people with Wrist Ganglion and Ganglion, run by Tampere University Hospital at 6 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Wrist Ganglion, Ganglion, Ganglion Cyst
What is being tested?
Open resection, Arthroscopic resection and Conservative treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
6 sitesin 2 countries
Study dates
13 Jan 2026to Dec 2035
Phase
Interventional

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • diagnosis of ganglion of the wrist, based on clinical examination or imaging findings
  • wrist pain located in the ganglion area
  • age over 18 years
  • ability to fill out the Finnish or English version of the questionnaires

Who cannot join

  • pregnant or breast feeding
  • other wrist pathology that likely explains the pain (e.g. osteoarthritis)
  • previous surgical treatment of the wrist
  • wrist ganglion presumed to be related to a work injury
  • symptomatic ganglion at both sides (volar and dorsal) of the wrist

Trial locations and contacts

6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Lasse Linnanmäki, MD, PhD contact

+3583311611

lasse.linnanmaki@fimnet.fi

6 sites in 2 countries

Finland5 sites, 5 recruiting
  • Helsinki University Hospital

    Helsinki, 00029

    Panu H Nordback, MD, PhD, +35894711, panu.nordback@hus.fi

    Panu H Nordback, MD, PhD

    Recruiting
  • Hospital Nova of Central Finland

    Jyväskylä, 40620

    Teemu Karjalainen, MD, PhD, +358142691811, teemu.karjalainen@hyvaks.fi

    Not yet recruiting
  • Päijät-Häme Central Hospital

    Lahti, 15850

    Marjut Westman, MD, PhD, +358381911, marjut.westman@paijatha.fi

    Marjut Westman, MD, PhD

    Recruiting
  • Oulu University Hospital

    Oulu, 90029

    Matti-Aleksi Mosorin, MD, PhD, +358086699500, matti-aleksi.mosorin@pohde.fi

    Matti-Aleksi Mosorin, MD, PhD

    Recruiting
  • Tampere University Hospital

    Tampere, 33521

    Lasse Linnanmäki, MD, PhD, +3583311611, lasse.linnanmaki@fimnet.fi

    Lasse Linnanmäki, MD, PhD

    Recruiting

Other trials in Finland

Singapore1 site, 1 recruiting
  • National University Hospital

    Singapore, 119228

    Alphonsus KS Chong, MD, PhD, +6569082222, alphonsus_chong@nuhs.edu.sg

    Alphonsus KS Chong, MD, PhD

    Not yet recruiting

Other trials in Singapore

About this study

Official title: GangLion Resection Effectiveness Trial (GangLion): a Multicentre, Randomized, Superiority Trial

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
Read the detailed description

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.

Being tested
Open resection, Arthroscopic resection, Conservative treatment
Keywords
ganglion, wrist
Medical subject headings
Ganglion Cysts, Connective Tissue Diseases, Mucinoses

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Open resectionProcedure or surgery

    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 resectionProcedure or surgery

    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 treatmentOther

    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. If a participant requests aspiration, the decision to perform it is left to the clinical discretion of the treating physician. 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 may avoid heavy use 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. Every participant is given simple self-implemented exercise therapy instructions; the exercises are to be performed three times a week until symptoms are relieved.

Study groups in NCT07162415
Study groupRoleWhat they receive
SurgeryExperimentalGanglion resection is performed in an operating room within 2 months of randomization, using either an open or an arthroscopic approach at the surgeon's discretion. There are no restrictions on anaesthesia methods. A bulky dressing is applied and removed within a week, and active range of motion exercises are begun immediately. Participants also receive the same self-implemented exercise instructions as the conservative treatment group.
Receives: Procedure: Open resection; Procedure: Arthroscopic resection
Conservative treatmentActive comparatorNot described
Receives: Other: Conservative treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient-Rated Wrist/Hand Evaluation (PRWHE) pain score

    The PRWHE is a 15-item questionnaire that is designed to measure wrist pain and disability in activities of daily living. Symptoms are described as average over the past week. The PRWHE consists of two subscales: pain and function. The PRWHE pain includes five items with combined score from 0 (no pain) to 50 (worst ever).

    Measured: 6 months follow-ups

Secondary outcomes (9)
  1. PRWHE pain score

    The PRWHE is a 15-item questionnaire that is designed to measure wrist pain and disability in activities of daily living. Symptoms are described as average over the past week. The PRWHE consists of two subscales: pain and function. The PRWHE pain includes five items with combined score from 0 (no pain) to 50 (worst ever).

    Measured: 3 and 12 months follow-ups

  2. PRWHE function score

    The PRWHE is a 15-item questionnaire that is designed to measure wrist pain and disability in activities of daily living. Symptoms are described as average over the past week. The PRWHE consists of two subscales: pain and function. Score of the PRWHE function ranges from 0 (no difficulty) to 50 (unable to do).

    Measured: 3, 6, and 12 months follow-ups

  3. PRWHE total score

    The PRWHE is a 15-item questionnaire that is designed to measure wrist pain and disability in activities of daily living. Symptoms are described as average over the past week. The PRWHE consists of two subscales: pain and function. The PRWHE total ranges from 0 (best) to 100 (worst).

    Measured: 3, 6, and 12 months follow-ups

  4. Global improvement

    Self-reported global improvement will be gathered as 7-step Likert scale as a response to question: "Compared with the beginning of the study, my wrist feels much worse - somewhat worse - little worse - no change - little better - somewhat better - much better."

    Measured: 3, 6, and 12 months follow-ups

  5. Patient Accepted Symptom State (PASS)

    PASS will be assessed using the question: "Considering the current symptoms and function of your wrist, are you satisfied with the outcome?" Participants will respond with either 'yes' or 'no'.

    Measured: 3, 6, and 12 months follow-ups

  6. Health-related quality of life

    Health-related quality of life is measured by EuroQol visual analogue scale (EQ VAS). EQ VAS is a component of 5-level EQ-5D questionnaire. It measures patient's overall current health-related quality of life in a 20 cm visual analogue scale. The scale ranges from 100 ("the best health state you can imagine") to 0 ("the worst health you can imagine").

    Measured: 3, 6, and 12 months follow-ups

  7. Presence of the ganglion

    The presence of the ganglion will be assessed through clinical examination.

    Measured: 6 months follow-ups

  8. Duration of sick leave

    The duration of sick leave is measured in days.

    Measured: 6 months follow-ups

  9. Adverse events

    Measured: 3, 6, and 12 months follow-ups

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2025
  2. Study start13 Jan 2026
  3. Primary completionDec 2034 (estimated)
  4. Study completionDec 2035 (estimated)

Resources

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
Model description
The trial design is multicentre, randomized, parallel group (1:1) controlled, superiority trial.
Masking
None (open label)
Enrolment
220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07162415
Sponsor's protocol ID
R25038
Acronym
GangLion
Status last verified
Oct 2026
First submitted
1 Sep 2025
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: On request and if current legislation allows, we will provide the anonymized data of the study.

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