Ganglion Resection Effectiveness Trial

NCT07162415 | Recruiting

• 1 other identifier: R25038
• Study Type: interventional
• Target: 220
• Locations: 2 countries
• Sites: 4

Brief 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 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

Conditions

Wrist Ganglion; Ganglion; Ganglion Cyst; Connective Tissue Disease; Mucinoses

Keywords

ganglion; wrist

Outcome Measures

Primary Outcomes (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).

  6 months follow-ups

Secondary Outcomes (9)

• PRWHE pain score

  3 and 12 months follow-ups

• PRWHE function score

  3, 6, and 12 months follow-ups

• PRWHE total score

  3, 6, and 12 months follow-ups

• Global improvement

  3, 6, and 12 months follow-ups

• Patient Accepted Symptom State (PASS)

  3, 6, and 12 months follow-ups

Study Arms (2)

Surgery

EXPERIMENTAL

Procedure: Open resection; Procedure: Arthroscopic resection

Conservative treatment

ACTIVE COMPARATOR

Other: Conservative treatment

Interventions

Open resection 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.

Surgery

Arthroscopic resection 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.

Surgery

Conservative treatment 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.

Conservative treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tampere University Hospital: lead
• Tampere University: collaborator
• Hospital Nova of Central Finland: collaborator
• National University Hospital, Singapore: collaborator
• Helsinki University Central Hospital: collaborator

Study Sites (4)

Helsinki University Hospital

Helsinki, 00029, Finland

NOT YET RECRUITING

Hospital Nova of Central Finland

Jyväskylä, 40620, Finland

NOT YET RECRUITING

Tampere University Hospital

Tampere, 33521, Finland

RECRUITING

National University Hospital

Singapore, 119228, Singapore

NOT YET RECRUITING

MeSH Terms

Conditions

Ganglion Cysts; Connective Tissue Diseases; Mucinoses

Interventions

Meniscectomy; Conservative Treatment

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Surgical Procedures, Operative; Therapeutics

Central Study Contacts

Lasse Linnanmäki, MD, PhD

CONTACT

+3583311611; lasse.linnanmaki@fimnet.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The trial design is multicentre, randomized, parallel group (1:1) controlled, superiority trial.

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: September 9, 2025
• Study Start: January 13, 2026
• Primary Completion (Estimated): December 1, 2034
• Study Completion (Estimated): December 1, 2035
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: The data will be available after the trial conclusion. All data will be retained for fifteen years following the conclusion of the trial.
• Access Criteria: On request.

Locations

FI (3); SG (1)