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Completed

NCT Number: NCT02312128

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

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Austrian Workers' Compensation Board Trauma Hospital Lorenz Böhler

Vienna, 1200, Austria

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire

Other

DASH Score, PRWE Score, Mayo Wrist Score

X- Ray

Radiation

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

Grip Strength

Other

Grip strength measurement

VAS Score

Other

Measurement pain according to the visual analogue scale (VAS)

Range of Motion measurement

Other

Angle measurement of the active range of motion in the wrist

Primary outcomes

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

    Time frame: one year

    Pain evaluation according the VAS Score

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

    Time frame: one year

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

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

    Time frame: one year

    Questionnaire: PRWE Score

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

    Time frame: One Year

    Questionnaire: DASH Score

  5. Functional Outcome as measured by Mayo Wrist Score

    Time frame: One year

    Questionnaire: Mayo Wrist Score

  6. Radiological outcome as measured by X-Ray

    Time frame: One Year

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

  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

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

    X-Ray of the wrist in two planes

  7. Grip strength

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

Sponsors and collaborators

Lead sponsor

Ludwig Boltzmann Gesellschaft

Other

Collaborators

  • Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 9, 2014
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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