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Onmiddellijke mobilisatie versus 2 weken cast-immobilisatie na distale radiusfractuur behandeld met volaire vergrendelingsplaat (LIMPER-DRF)

31 oktober 2026 bijgewerkt door: Aleksi Reito, Tampere University Hospital

Onmiddellijke mobilisatie versus 2 weken cast-immobilisatie na distale radiusfractuur behandeld met volaire vergrendelingsplaat - een studieprotocol voor een prospectieve, gerandomiseerde, gecontroleerde studie

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.

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

240

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Finland
      • Jyväskylä, Finland
        • Teemu Karjalainen
      • Kuopio, Finland
        • Kuopio University Hospital
      • Tampere, Finland
        • Laura Kärnä
  • Zweden
      • Danderyd, Zweden
        • Danderyds Sjukhus
      • Sundsvall, Zweden
        • Sundsvalls sjukhuset

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 65 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Onmiddellijke mobilisatie na distale radiusfractuur behandeld met volaire vergrendelingsplaat
Ander: Immediate mobilization

Immediate mobilization postoperatively without casting

Procedure: Volar plating

Volar plating of distal radius fracture
Actieve vergelijker: 2 weken gipsimmobilisatie na distale radiusfractuur behandeld met volaire vergrendelingsplaat
Procedure: Volar plating

Volar plating of distal radius fracture

Ander: Cast treatment

Dorsal cast placed in OR

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Patient-rated wrist evaluation questionnaire
Tijdsspanne: 2 months

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
Tijdsspanne: 12 months

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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Patient-rated wrist evaluation questionnaire
Tijdsspanne: 4 weeks

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.
4 weeks
Patient-rated wrist evaluation questionnaire
Tijdsspanne: 6 months

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.
6 months
Patient-rated wrist evaluation questionnaire
Tijdsspanne: 12 months

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.
12 months
Return to work
Tijdsspanne: 4 weeks

Patient is asked if he or she has returned to the previous work. If no patient is asked is he or she Still on sick leave, partial sick leave or returned to other work.
4 weeks
Return to work
Tijdsspanne: 2 months

Patient is asked if he or she has returned to the previous work. If no patient is asked is he or she Still on sick leave, partial sick leave or returned to other work.
2 months
Return to work
Tijdsspanne: 6 months

Patient is asked if he or she has returned to the previous work. If no patient is asked is he or she Still on sick leave, partial sick leave or returned to other work.
6 months
Return to work
Tijdsspanne: 12 months

Patient is asked if he or she has returned to the previous work. If no patient is asked is he or she Still on sick leave, partial sick leave or returned to other work.
12 months
Complications
Tijdsspanne: 4 weeks

Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome
4 weeks
Complications
Tijdsspanne: 2 months

Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome
2 months
Complications
Tijdsspanne: 6 months

Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome
6 months
Complications
Tijdsspanne: 12 months

Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome
12 months
Self-perceived working ability
Tijdsspanne: 4 weeks

Patient is asked to rate his os her working ability using two scales: NRS from 0 (fully disabled) to 10 (best capability) and ordinally (fully capable, partially capable, fully disabled).
4 weeks
Self-perceived working ability
Tijdsspanne: 2 months

Patient is asked to rate his os her working ability using two scales: NRS from 0 (fully disabled) to 10 (best capability) and ordinally (fully capable, partially capable, fully disabled).
2 months
Self-perceived working ability
Tijdsspanne: 6 months

Patient is asked to rate his os her working ability using two scales: NRS from 0 (fully disabled) to 10 (best capability) and ordinally (fully capable, partially capable, fully disabled).
6 months
Self-perceived working ability
Tijdsspanne: 12 months

Patient is asked to rate his os her working ability using two scales: NRS from 0 (fully disabled) to 10 (best capability) and ordinally (fully capable, partially capable, fully disabled).
12 months
Visual analogue pain scale
Tijdsspanne: 4 weeks

Overall pain during last 7 days in a scale from 0 to 100 (worst)
4 weeks
Visual analogue pain scale
Tijdsspanne: 2 months

Overall pain during last 7 days in a scale from 0 to 100 (worst)
2 months
Visual analogue pain scale
Tijdsspanne: 6 months

Overall pain during last 7 days in a scale from 0 to 100 (worst)
6 months
Visual analogue pain scale
Tijdsspanne: 12 months

Overall pain during last 7 days in a scale from 0 to 100 (worst)
12 months
Patient-acceptable symptom state
Tijdsspanne: 2 months

Patient satisfaction will be measured using the patient-acceptable symptom state (PASS).The questionnaires will include the following questions: Would you be willing to take the same treatment again if the treatment result was as it is now? (Yes/No) Considering all the different ways your injury is affecting you, if you would remain in this state, do you feel that your current state is satisfactory (Yes/No)?
2 months
Patient-acceptable symptom state
Tijdsspanne: 6 months

Patient satisfaction will be measured using the patient-acceptable symptom state (PASS).The questionnaires will include the following questions: Would you be willing to take the same treatment again if the treatment result was as it is now? (Yes/No) Considering all the different ways your injury is affecting you, if you would remain in this state, do you feel that your current state is satisfactory (Yes/No)?
6 months
Patient-acceptable symptom state
Tijdsspanne: 12 months

Patient satisfaction will be measured using the patient-acceptable symptom state (PASS).The questionnaires will include the following questions: Would you be willing to take the same treatment again if the treatment result was as it is now? (Yes/No) Considering all the different ways your injury is affecting you, if you would remain in this state, do you feel that your current state is satisfactory (Yes/No)?
12 months
Work capacity
Tijdsspanne: 4 weeks

The participants will be asked to rate their working capacity on a numerical scale from 0 to 10, with "0" being not able to work at all and "10" being the ability to work at its best.
4 weeks
Work capacity
Tijdsspanne: 2 months

The participants will be asked to rate their working capacity on a numerical scale from 0 to 10, with "0" being not able to work at all and "10" being the ability to work at its best.
2 months
Work capacity
Tijdsspanne: 6 months

The participants will be asked to rate their working capacity on a numerical scale from 0 to 10, with "0" being not able to work at all and "10" being the ability to work at its best.
6 months
Work capacity
Tijdsspanne: 12 months

The participants will be asked to rate their working capacity on a numerical scale from 0 to 10, with "0" being not able to work at all and "10" being the ability to work at its best.
12 months

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Patient activity
Tijdsspanne: 4 weeks

Patient activity measured with triaxial wrist accelerometer
4 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Tampere University Hospital

Medewerkers

Kuopio University Hospital
Sundsvall Hospital
Danderyd Hospital
Jyväskylä Central Hospital

Onderzoekers

  • Studie directeur: Aleksi Reito, Tampere University Hospital
  • Hoofdonderzoeker: Laura Kärnä, MD, Tampere University Hospital

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 december 2021

Primaire voltooiing (Werkelijk)

10 februari 2026

Studie voltooiing (Geschat)

10 februari 2027

Studieregistratiedata

Eerst ingediend

7 oktober 2021

Eerst ingediend dat voldeed aan de QC-criteria

26 november 2021

Eerst geplaatst (Werkelijk)

9 december 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 november 2026

Laatste update ingediend die voldeed aan QC-criteria

31 oktober 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • R21111

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

Data is available on reasonable request.

IPD-tijdsbestek voor delen

After the study has been completed and for 10 years after.

IPD-toegangscriteria voor delen

On reasonable request and research plan for IPD use should be provided.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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