NCT05150925

Brief Summary

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.

Trial Health

78
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Dec 2021

Longer than P75 for not_applicable

Geographic Reach
2 countries

5 active sites

Status
active not 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 Progress85%
Dec 2021Feb 2027

First Submitted

Initial submission to the registry

October 7, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 9, 2021

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2027

Expected
Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

4.2 years

First QC Date

October 7, 2021

Last Update Submit

February 10, 2026

Conditions

Distal Radius Fracture

Keywords

distal radius fracturevolar platingsurgery

Outcome Measures

Primary Outcomes (2)

  • Patient-rated wrist evaluation questionnaire

    The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in daily activities. It ranges from 100 (worst) to 0 (best). It consists of 2 subscales. Pain subscale contains 5 items. Function subscale contains total 10 items which are further divided into 2 sections: specific activities (having 6 items) and usual activities.

    2 months

  • Total lenght of the sick leave

    Total number of days of work during the 1 year study period

    12 months

Secondary Outcomes (26)

  • Patient-rated wrist evaluation questionnaire

    4 weeks

  • Patient-rated wrist evaluation questionnaire

    6 months

  • Patient-rated wrist evaluation questionnaire

    12 months

  • Return to work

    4 weeks

  • Return to work

    2 months

  • +21 more secondary outcomes

Other Outcomes (1)

  • Patient activity

    4 weeks

Study Arms (2)

Immediate mobilization after distal radius fracture treated with volar locking plate

EXPERIMENTAL
Other: Immediate mobilizationProcedure: Volar plating

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

ACTIVE COMPARATOR
Other: Cast treatmentProcedure: Volar plating

Interventions

Cast treatmentOTHER

Dorsal cast placed in OR

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

Immediate mobilization postoperatively without casting

Immediate mobilization after distal radius fracture treated with volar locking plate
Volar platingPROCEDURE

Volar plating of distal radius fracture

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Teemu Karjalainen

Jyväskylä, Finland

Location

Kuopio University Hospital

Kuopio, Finland

Location

Laura Kärnä

Tampere, Finland

Location

Danderyds Sjukhus

Danderyd, Sweden

Location

Sundsvalls sjukhuset

Sundsvall, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 36368761DERIVED

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Study Officials

  • Aleksi Reito

    Tampere University Hospital

    STUDY DIRECTOR

  • Laura Kärnä, MD

    Tampere University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

October 7, 2021

First Posted

December 9, 2021

Study Start

December 1, 2021

Primary Completion

February 10, 2026

Study Completion (Estimated)

February 10, 2027

Last Updated

February 11, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

Data is available on reasonable request.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
After the study has been completed and for 10 years after.
Access Criteria
On reasonable request and research plan for IPD use should be provided.

Locations

FI(3)SE(2)