Overview

This trial is active, not recruiting.

Condition closed fracture of lower end of radius and ulna
Treatments questionnaire, x- ray, grip strength, vas score, range of motion measurement
Sponsor Ludwig Boltzmann Gesellschaft
Collaborator Ludwig Boltzmann Institute for Experimental und Clinical Traumatology
Start date January 2015
End date August 2016
Trial size 146 participants
Trial identifier NCT02312128, 03/2010

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
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
questionnaire
DASH Score, PRWE Score, Mayo Wrist Score
x- ray
X-ray exposures in two planes 6., 9., 12. postoperative week, half and one year after surgery
grip strength
Grip strength measurement
vas score
Measurement pain according to the visual analogue scale (VAS)
range of motion measurement
Angle measurement of the active range of motion in the wrist
(Active Comparator)
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
questionnaire
DASH Score, PRWE Score, Mayo Wrist Score
x- ray
X-ray exposures in two planes 6., 9., 12. postoperative week, half and one year after surgery
grip strength
Grip strength measurement
vas score
Measurement pain according to the visual analogue scale (VAS)
range of motion measurement
Angle measurement of the active range of motion in the wrist

Primary Outcomes

Measure
Functional Outcome as measured by visual analogue scale (VAS)
time frame: one year
Functional Outcome as measured by Range of Motion (ROM)
time frame: one year
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
Functional Outcome as measured by Disabilities of the Arm, Shoulder and Hand (DASH) Score
time frame: One Year
Functional Outcome as measured by Mayo Wrist Score
time frame: One year
Radiological outcome as measured by X-Ray
time frame: One Year
Functional Outcome as measured by Grip Strength
time frame: one year

Secondary Outcomes

Measure
change Range of motion
time frame: 6., 9., 12. week postsurgery, a half and one year after surgery
Change Pain
time frame: 6., 9., 12. week postsurgery, a half and one year after surgery
Change Disabilities of the Arm, Shoulder and Hand (DASH) Score
time frame: 6., 9., 12. week postsurgery, a half and one year after surgery
Change Patient-Rated Wrist Evaluation (PRWE) Score
time frame: 6., 9., 12. week postsurgery, a half and one year after surgery
Change Mayo Wrist Score
time frame: 6., 9., 12. week postsurgery, a half and one year after surgery
Change X-Ray
time frame: 6., 9., 12. week postsurgery, a half and one year after surgery
Grip strength
time frame: 6., 9., 12. week postsurgery, a half and one year after surgery

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title Early Mobilization of Operatively Stabilized Distal Radius Fractures - a Randomized Controlled Trail
Principal investigator Stefan Quadlbauer, M.D.
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
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Ludwig Boltzmann Gesellschaft.