Immediate Mobilization Versus 2 Weeks Cast Immobilization After Distal Radius Fracture Treated With Volar Locking Plate

NCT ID: NCT05150925

Last Updated: 2025-11-28

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

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2026-12-31

Brief Summary

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The aim of this study is to analyze total lenght of the sick leace and functional outcome (PRWE) at 2 months between 2 weeks casting and immediate mobilization following volar plating for a DRF.

Detailed Description

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This study is a prospective, randomized, controlled trial. The aim of this study will be to compare the early postoperative outcomes of the patients enrolled in the early mobilization with those patients in post-operative 2-week casting following volar plating for a DRF. Co-primary outcome in this study will be the total lenght of sick leave and Patient-Rated Wrist Evaluation (PRWE) 2 months after the operation.

Conditions

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Distal Radius Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Immediate mobilization after distal radius fracture treated with volar locking plate

Group Type EXPERIMENTAL

Immediate mobilization

Intervention Type OTHER

Immediate mobilization postoperatively without casting

Volar plating

Intervention Type PROCEDURE

Volar plating of distal radius fracture

2 weeks cast immobilization after distal radius fracture treated with volar locking plate

Group Type ACTIVE_COMPARATOR

Cast treatment

Intervention Type OTHER

Dorsal cast placed in OR

Volar plating

Intervention Type PROCEDURE

Volar plating of distal radius fracture

Interventions

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Cast treatment

Dorsal cast placed in OR

Intervention Type OTHER

Immediate mobilization

Immediate mobilization postoperatively without casting

Intervention Type OTHER

Volar plating

Volar plating of distal radius fracture

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Intra- or extra articular DRF (Colles, Smith, Volar barton)
* operative treatment justified

Exclusion Criteria

* Refusal to participate in the study
* Open fracture with a severity greater than Gustilo grade 1
* Patient aged less than 18 or over 65
* Patient does not understand written or spoken guidance in local languages
* Pathological fracture
* Previous fracture in the same wrist or forearm in the last 10 years, that has led to impairment of function
* Ipsilateral fracture in upper extremity
* Associated fractures of the ulna (except fractures of the PSU)
* Polytrauma
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kuopio University Hospital

OTHER

Sponsor Role collaborator

Jyväskylä Central Hospital

OTHER

Sponsor Role collaborator

Sundsvall Hospital

OTHER

Sponsor Role collaborator

Danderyd Hospital

OTHER

Sponsor Role collaborator

Tampere University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Aleksi Reito

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aleksi Reito

Role: STUDY_DIRECTOR

Tampere University Hospital

Laura Kärnä, MD

Role: PRINCIPAL_INVESTIGATOR

Tampere University Hospital

Locations

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Teemu Karjalainen

Jyväskylä, , Finland

Site Status RECRUITING

Kuopio University Hospital

Kuopio, , Finland

Site Status RECRUITING

Laura Kärnä

Tampere, , Finland

Site Status RECRUITING

Danderyds Sjukhus

Danderyd, , Sweden

Site Status RECRUITING

Sundsvalls sjukhuset

Sundsvall, , Sweden

Site Status RECRUITING

Countries

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Finland Sweden

Central Contacts

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Laura Kärnä, MD

Role: CONTACT

+3583311611

Antti Launonen

Role: CONTACT

+3583311611

Facility Contacts

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Toni Luokkala

Role: primary

+358142691811

Katriina Paasikallio

Role: primary

+35817173311

Laura Kärnä

Role: primary

+3583311611

Viktor Schmidt

Role: primary

+46812355000

Mats Wadsten

Role: primary

+4660181000

References

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Karna L, Launonen AP, Karjalainen T, Luokkala T, Ponkilainen V, Halonen L, Helminen M, Mattila VM, Reito A. LIMPER trials: immediate mobilisation versus 2-week cast immobilisation after distal radius fracture treated with volar locking plate - a study protocol for a prospective, randomised, controlled trial. BMJ Open. 2022 Nov 11;12(11):e064440. doi: 10.1136/bmjopen-2022-064440.

Reference Type DERIVED
PMID: 36368761 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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R21111

Identifier Type: -

Identifier Source: org_study_id

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