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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02312128
Enrollment
116
Registered
2014-12-09
Start date
2015-01-31
Completion date
2017-07-31
Last updated
2019-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Closed Fracture of Lower End of Radius and Ulna

Keywords

distal radius fractures, early mobilization, postoperative treatment, outcome

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

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

Grip strength measurement

Measurement pain according to the visual analogue scale (VAS)

OTHERRange of Motion measurement

Angle measurement of the active range of motion in the wrist

Sponsors

Ludwig Boltzmann Institute for Experimental und Clinical Traumatology
CollaboratorUNKNOWN
Ludwig Boltzmann Gesellschaft
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Functional Outcome as measured by Grip Strengthone year
Functional Outcome as measured by visual analogue scale (VAS)one yearPain evaluation according the VAS Score
Functional Outcome as measured by Range of Motion (ROM)one yearRange 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) Scoreone yearQuestionnaire: PRWE Score
Functional Outcome as measured by Disabilities of the Arm, Shoulder and Hand (DASH) ScoreOne YearQuestionnaire: DASH Score
Functional Outcome as measured by Mayo Wrist ScoreOne yearQuestionnaire: Mayo Wrist Score
Radiological outcome as measured by X-RayOne YearRadiological outcome in x-ray of the Wrist in two planes

Secondary

MeasureTime frameDescription
change Range of motion6., 9., 12. week postsurgery, a half and one year after surgery
Change Pain6., 9., 12. week postsurgery, a half and one year after surgery
Change Disabilities of the Arm, Shoulder and Hand (DASH) Score6., 9., 12. week postsurgery, a half and one year after surgery
Change Patient-Rated Wrist Evaluation (PRWE) Score6., 9., 12. week postsurgery, a half and one year after surgery
Change Mayo Wrist Score6., 9., 12. week postsurgery, a half and one year after surgery
Change X-Ray6., 9., 12. week postsurgery, a half and one year after surgeryX-Ray of the wrist in two planes
Grip strength6., 9., 12. week postsurgery, a half and one year after surgery

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026