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

Primary Purpose

Closed Fracture of Lower End of Radius and Ulna

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Questionnaire
X- Ray
Grip Strength
VAS Score
Range of Motion measurement
Sponsored by
Ludwig Boltzmann Gesellschaft
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Closed Fracture of Lower End of Radius and Ulna focused on measuring distal radius fractures, early mobilization, postoperative treatment, outcome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Austrian Workers' Compensation Board Trauma Hospital Lorenz Böhler

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Early Mobilisation

Cast Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Functional Outcome as measured by visual analogue scale (VAS)
Pain evaluation according the VAS Score
Functional Outcome as measured by Range of Motion (ROM)
Range of Motion measured in sagittal plane, frontal plane and forearm rotation
Functional Outcome as measured by Patient - Rated Wrist Evaluation Score Patient - Functional Outcome as measured by Rated Wrist Evaluation (PRWE) Score
Questionnaire: PRWE Score
Functional Outcome as measured by Disabilities of the Arm, Shoulder and Hand (DASH) Score
Questionnaire: DASH Score
Functional Outcome as measured by Mayo Wrist Score
Questionnaire: Mayo Wrist Score
Radiological outcome as measured by X-Ray
Radiological outcome in x-ray of the Wrist in two planes
Functional Outcome as measured by Grip Strength

Secondary Outcome Measures

change Range of motion
Change Pain
Change Disabilities of the Arm, Shoulder and Hand (DASH) Score
Change Patient-Rated Wrist Evaluation (PRWE) Score
Change Mayo Wrist Score
Change X-Ray
X-Ray of the wrist in two planes
Grip strength

Full Information

First Posted
December 1, 2014
Last Updated
February 1, 2019
Sponsor
Ludwig Boltzmann Gesellschaft
Collaborators
Ludwig Boltzmann Institute for Experimental und Clinical Traumatology
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1. Study Identification

Unique Protocol Identification Number
NCT02312128
Brief Title
Early Mobilization of Operatively Stabilized Distal Radius Fractures - a Randomized Controlled Trail
Official Title
Early Mobilization of Operatively Stabilized Distal Radius Fractures - a Randomized Controlled Trail
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ludwig Boltzmann Gesellschaft
Collaborators
Ludwig Boltzmann Institute for Experimental und Clinical Traumatology

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Closed Fracture of Lower End of Radius and Ulna
Keywords
distal radius fractures, early mobilization, postoperative treatment, outcome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early Mobilisation
Arm Type
Active Comparator
Arm Description
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
Arm Title
Cast Group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Questionnaire
Intervention Description
DASH Score, PRWE Score, Mayo Wrist Score
Intervention Type
Radiation
Intervention Name(s)
X- Ray
Intervention Description
X-ray exposures in two planes 6., 9., 12. postoperative week, half and one year after surgery
Intervention Type
Other
Intervention Name(s)
Grip Strength
Intervention Description
Grip strength measurement
Intervention Type
Other
Intervention Name(s)
VAS Score
Intervention Description
Measurement pain according to the visual analogue scale (VAS)
Intervention Type
Other
Intervention Name(s)
Range of Motion measurement
Intervention Description
Angle measurement of the active range of motion in the wrist
Primary Outcome Measure Information:
Title
Functional Outcome as measured by visual analogue scale (VAS)
Description
Pain evaluation according the VAS Score
Time Frame
one year
Title
Functional Outcome as measured by Range of Motion (ROM)
Description
Range of Motion measured in sagittal plane, frontal plane and forearm rotation
Time Frame
one year
Title
Functional Outcome as measured by Patient - Rated Wrist Evaluation Score Patient - Functional Outcome as measured by Rated Wrist Evaluation (PRWE) Score
Description
Questionnaire: PRWE Score
Time Frame
one year
Title
Functional Outcome as measured by Disabilities of the Arm, Shoulder and Hand (DASH) Score
Description
Questionnaire: DASH Score
Time Frame
One Year
Title
Functional Outcome as measured by Mayo Wrist Score
Description
Questionnaire: Mayo Wrist Score
Time Frame
One year
Title
Radiological outcome as measured by X-Ray
Description
Radiological outcome in x-ray of the Wrist in two planes
Time Frame
One Year
Title
Functional Outcome as measured by Grip Strength
Time Frame
one year
Secondary Outcome Measure Information:
Title
change Range of motion
Time Frame
6., 9., 12. week postsurgery, a half and one year after surgery
Title
Change Pain
Time Frame
6., 9., 12. week postsurgery, a half and one year after surgery
Title
Change Disabilities of the Arm, Shoulder and Hand (DASH) Score
Time Frame
6., 9., 12. week postsurgery, a half and one year after surgery
Title
Change Patient-Rated Wrist Evaluation (PRWE) Score
Time Frame
6., 9., 12. week postsurgery, a half and one year after surgery
Title
Change Mayo Wrist Score
Time Frame
6., 9., 12. week postsurgery, a half and one year after surgery
Title
Change X-Ray
Description
X-Ray of the wrist in two planes
Time Frame
6., 9., 12. week postsurgery, a half and one year after surgery
Title
Grip strength
Time Frame
6., 9., 12. week postsurgery, a half and one year after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Quadlbauer, M.D.
Organizational Affiliation
AUVA Traumazentrum Vienna Site UKH Meidling
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martin Leixnering, M.D.
Organizational Affiliation
AUVA Traumazentrum Vienna Site UKH Meidling
Official's Role
Study Director
Facility Information:
Facility Name
Austrian Workers' Compensation Board Trauma Hospital Lorenz Böhler
City
Vienna
ZIP/Postal Code
1200
Country
Austria

12. IPD Sharing Statement

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

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