NCT07042139

Brief Summary

DISCLOSE trial is a randomized controlled trial including 532 participants with low-energy distal radius fractures. The primary objective is to evaluate whether casting without prior closed reduction is equivalent to casting following closed reduction with respect to wrist-related pain and disability, as measured by the Patient-Rated Wrist Evaluation (PRWE) score at 12 months, in patients aged 65 years or older with a displaced distal radius fracture.

  • Primary endpoint will be PRWE at 12 months
  • Follow-up visits are scheduled at 3 and 12 months. 5-year follow-up will be considered as an exploratory endpoint

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
532

participants targeted

Target at P75+ for not_applicable

Timeline
87mo left

Started Aug 2025

Longer than P75 for not_applicable

Geographic Reach
4 countries

10 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
Aug 2025Jul 2033

First Submitted

Initial submission to the registry

April 14, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 27, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2029

Expected
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2033

Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

3.9 years

First QC Date

April 14, 2025

Last Update Submit

January 19, 2026

Conditions

Distal Radius FractureCastingClosed Reduction

Keywords

distal radius fracturecastingclosed reductionnonoperative treatmentDISCLOSE trial

Outcome Measures

Primary Outcomes (1)

  • PRWE

    Primary outcome will be the Patient Rated Wrist Evaluation (PRWE) at 12 months. PRWE is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living. The questionnaire consists of two subscales (pain and function), and the score ranges from 0 (no disability) to 100 (severe disability).

    12 months

Secondary Outcomes (5)

  • Pain (NRS)

    3 months and 12 months

  • PASS

    3 months and 12 months

  • EQ-5D-5L- Quality of life

    3 months and 12 months

  • Serious adverse events

    3 months and 1 year

  • Cosmesis

    3 months

Other Outcomes (4)

  • Radiographic measurements

    Baseline and 3 months

  • Tri-Axial Accelerometry (Published separately)

    3 and 12 months

  • Cost-effectiveness (Published separately)

    12 months

  • +1 more other outcomes

Study Arms (2)

Closed Reduction

ACTIVE COMPARATOR

Closed reduction and casting after distal radius fracture

Procedure: Closed ReductionOther: Casting

No Reduction

EXPERIMENTAL

Casting without reduction after distal radius fracture

Procedure: No reductionOther: Casting

Interventions

No reductionPROCEDURE

No reduction

No Reduction
Closed ReductionPROCEDURE

Closed reduction

Closed Reduction
CastingOTHER

Dorsal cast

Closed ReductionNo Reduction

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age 65 years or older
  • Independent living patients
  • Displaced distal radius fracture (AO/OTA 23A/23C) with 15-40 degree dorsal angulation, and/or of shortening of the radius for more than 2 mm.
  • Associated ulnar styloid fracture is permitted
  • Low energy injury, (fall from \<1 m)

You may not qualify if:

  • Patient unable to provide consent
  • Patients who are actively working in a paid position
  • Volar angulation, partial articular fractures (AO/OTA 23B)
  • Concomitant fracture of the ulna proximal to the base of the styloid process
  • Associated fracture or dislocation in any other body part that would affect the use of the injured distal radius
  • Distal radius fractures in both arms
  • Open injury, Gustilo 2 or higher
  • No bony contact between the main fragments
  • High energy injuries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Viborg regional Hospital

Viborg, Denmark

RECRUITING

Tartu University Hospital

Tartu, Estonia

RECRUITING

Tampere University Hospital

Tampere, Pirkanmaa, 33520, Finland

RECRUITING

Helsinki University Hospital

Helsinki, Uusimaa, 00260, Finland

RECRUITING

Kanta-Häme Central Hospital

Hämeenlinna, Finland

RECRUITING

Kuopio University Hospital

Kuopio, Finland

RECRUITING

Oulu University Hospital

Oulu, 90220, Finland

RECRUITING

Pori Central Hospital

Pori, Finland

NOT YET RECRUITING

Turku University Hospital

Turku, Finland

NOT YET RECRUITING

Karolinska University Hospital

Stockholm, Sweden

NOT YET RECRUITING

Related Publications (1)

  • Karna L, Ponkilainen V, Reito A, Ostergaard H, Brorson S, Tootsi K, Paasikallio K, Senholt T, Li Y, Heikkinen J, Kukkonen J, Ryhanen J, Christensen R, Mattila VM, Launonen AP. Effect of no reduction versus closed reduction on distal radius fractures in adults aged 65 years and older: a protocol for the DISCLOSE randomised equivalence trial. BMJ Open. 2025 Oct 16;15(10):e108511. doi: 10.1136/bmjopen-2025-108511.

    PMID: 41101953DERIVED

MeSH Terms

Conditions

Wrist Fractures

Interventions

Closed Fracture Reduction

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Intervention Hierarchy (Ancestors)

Fracture FixationOrthopedic ProceduresTherapeutics

Study Officials

  • Laura Kärnä, MD

    Tampere University Hospital

    PRINCIPAL INVESTIGATOR

  • Ville Ponkilainen

    Tampere University Hospital

    PRINCIPAL INVESTIGATOR

  • Antti Launonen

    Tampere University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Kärnä, MD

CONTACT

+3583311611laura.karna@pirha.fi

Ville Ponkilainen, MD, PhD

CONTACT

+3583311611ville@disclosetrial.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
To minimize the risk of biased interpretation, the trial results will be analyzed using a blinded data interpretation process, in which the statistician will remain masked to the group allocations.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2025

First Posted

June 27, 2025

Study Start

August 1, 2025

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

July 1, 2033

Last Updated

January 21, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

IPD will not be shared due to restrictions under Finnish data protection regulations, which limit the sharing of sensitive personal data, even in de-identified form, without specific consent or legal basis.

Locations

ES(1)SE(1)FI(7)DK(1)