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CompletedNCT02312128Updated Feb 4, 2019

Early Mobilization of Operatively Stabilized Distal Radius Fractures - a Randomized Controlled Trail

An interventional study of Questionnaire and X- Ray in Closed Fracture of Lower End of Radius and Ulna, sponsored by Ludwig Boltzmann Gesellschaft. Completed at 1 site in Austria. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-02-04.

Sponsored by Ludwig Boltzmann Gesellschaft · Not applicable, Interventional, and Treatment

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Phase
Not applicable
Study type
Interventional
Enrollment
116
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate if an early mobilization after distal radius fractures treated by surgery leads to an better functional outcome then immobilization after surgery for 5 weeks in a cast

Read the detailed description

All patients with a distal radius fracture treated by surgery (palmar angle stable plate) will be included in this study and randomised into two groups according the CONSORT Guidelines of Prospective Randomised Trails. One group ("early mobilisation") receive a removable plastic cast for one week and are allowed to move the wrist directly postoperative.

The other group ("control group") received a non removable cast for 5 weeks. Both groups underwent physiotherapy two times a week. The control group was only allowed to move the closed-by joints.

In the 6., 9., 12. postoperative week, a half and one year after the operation the patients underwent range of motion (ROM), grip strength measurement and pain according to the visual analogue scale (VAS). Hand function will be analysed according the PRWE (Patient-Rated Wrist Evaluation) Score, DASH (Disabilities of the Arm, Shoulder and Hand) Score and Mayo Wrist Score.

  • Inclusion criteria:

    • Age ≥ 18 and ≤ 75 years
    • A2 - C3 distal radius fracture
    • no acute or older injury that influences hand function
    • operative stabilized by palmar angle stable plate
  • Exclusion criteria:

    • Age ≥ 76 years
    • Age \< 18 years
    • C3.3 radius fracture
    • acute or preexisting injures that influences hand function
    • pregnancy
    • neurologic disorders
    • incapacitated people
02

Conditions studied

  • Closed Fracture of Lower End of Radius and Ulna

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Keywords

  • distal radius fractures
  • early mobilization
  • postoperative treatment
  • outcome
03

In context

Wrist Fractures

330 studies on the registry are indexed under Wrist Fractures; 72 are open to participants now.

This study's enrollment of 116 is above the median of 63 across 265 interventional studies indexed under Wrist Fractures.

Browse Wrist Fractures studies →

Lead sponsor

Ludwig Boltzmann Gesellschaft is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥ 18 and ≤ 75 years
  • A2 - C3 distal radius fracture
  • no acute or older injury that influences hand function
  • operative stabilized by palmar angle stable plate

Exclusion criteria

Exclusion Criteria:

  • Age ≥ 76 years
  • Age \< 18 years
  • C3.3 radius fracture
  • acute or preexisting injures that influences hand function pregnancy neurologic disorders incapacitated people
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
116 participants (actual)

Study arms

  • Active comparator
    Early Mobilisation

    receives a removable plastic cast for one week and is allowed to move the wrist directly postoperative. Interventions: * Range of Motion measurement (ROM), * Grip strength measurement, * VAS Score according to the visual analogue scale (). * Questionnaire: PRWE Score, DASH Score and Mayo Wrist Score. * X- Rays in two planes. Follow-up: 6., 9., 12. postoperative week, a half and one year after surgery

    Other: Questionnaire · Radiation: X- Ray · Other: Grip Strength · Other: VAS Score · Other: Range of Motion measurement

  • Active comparator
    Cast Group

    receives a non removable cast for 5 weeks Interventions: * Range of Motion measurement (ROM), * Grip strength measurement, * VAS Score according to the visual analogue scale (). * Questionnaire: PRWE Score, DASH Score and Mayo Wrist Score. * X- Rays in two planes. Follow-up: 6., 9., 12. postoperative week, a half and one year after surgery

    Other: Questionnaire · Radiation: X- Ray · Other: Grip Strength · Other: VAS Score · Other: Range of Motion measurement

Interventions

  • OtherQuestionnaire

    DASH Score, PRWE Score, Mayo Wrist Score

  • RadiationX- Ray

    X-ray exposures in two planes 6., 9., 12. postoperative week, half and one year after surgery

  • OtherGrip Strength

    Grip strength measurement

  • OtherVAS Score

    Measurement pain according to the visual analogue scale (VAS)

  • OtherRange of Motion measurement

    Angle measurement of the active range of motion in the wrist

06

What researchers measure

Primary outcomes

  1. Functional Outcome as measured by visual analogue scale (VAS)

    Pain evaluation according the VAS Score

    Time frame: one year

  2. Functional Outcome as measured by Range of Motion (ROM)

    Range of Motion measured in sagittal plane, frontal plane and forearm rotation

    Time frame: one year

  3. Functional Outcome as measured by Patient - Rated Wrist Evaluation Score Patient - Functional Outcome as measured by Rated Wrist Evaluation (PRWE) Score

    Questionnaire: PRWE Score

    Time frame: one year

  4. Functional Outcome as measured by Disabilities of the Arm, Shoulder and Hand (DASH) Score

    Questionnaire: DASH Score

    Time frame: One Year

  5. Functional Outcome as measured by Mayo Wrist Score

    Questionnaire: Mayo Wrist Score

    Time frame: One year

  6. Radiological outcome as measured by X-Ray

    Radiological outcome in x-ray of the Wrist in two planes

    Time frame: One Year

  7. Functional Outcome as measured by Grip Strength

    Time frame: one year

Secondary outcomes

  1. change Range of motion

    Time frame: 6., 9., 12. week postsurgery, a half and one year after surgery

  2. Change Pain

    Time frame: 6., 9., 12. week postsurgery, a half and one year after surgery

  3. Change Disabilities of the Arm, Shoulder and Hand (DASH) Score

    Time frame: 6., 9., 12. week postsurgery, a half and one year after surgery

  4. Change Patient-Rated Wrist Evaluation (PRWE) Score

    Time frame: 6., 9., 12. week postsurgery, a half and one year after surgery

  5. Change Mayo Wrist Score

    Time frame: 6., 9., 12. week postsurgery, a half and one year after surgery

  6. Change X-Ray

    X-Ray of the wrist in two planes

    Time frame: 6., 9., 12. week postsurgery, a half and one year after surgery

  7. Grip strength

    Time frame: 6., 9., 12. week postsurgery, a half and one year after surgery

07

Study locations

1 site
  • Austrian Workers' Compensation Board Trauma Hospital Lorenz Böhler
    Vienna, 1200, Austria
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2015, a primary completion of Jul 2017 and a completion of Jul 2017. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 1, 2014
First posted
Dec 9, 2014
Start
Jan 2015
Primary completionActual
Jul 2017
CompletionActual
Jul 2017
Last update
Feb 4, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02312128
Lead sponsor
Ludwig Boltzmann Gesellschaft
Collaborators
Ludwig Boltzmann Institute for Experimental und Clinical Traumatology
Responsible party
Stefan Quadlbauer, M.D. (M.D., AUVA Traumazentrum Vienna Site UKH Meidling) — Principal investigator
First posted
Dec 9, 2014
Start date
Jan 2015
Primary completion
Jul 2017
Completion
Jul 2017
Last update
Feb 4, 2019

Study contacts

Stefan Quadlbauer, M.D.
principal investigator · AUVA Traumazentrum Vienna Site UKH Meidling
Martin Leixnering, M.D.
study director · AUVA Traumazentrum Vienna Site UKH Meidling

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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