Trials / Completed
CompletedNCT02312128
Early Mobilization of Operatively Stabilized Distal Radius Fractures - a Randomized Controlled Trail
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 116 (actual)
- Sponsor
- Ludwig Boltzmann Gesellschaft · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Questionnaire | DASH Score, PRWE Score, Mayo Wrist Score |
| RADIATION | X- Ray | X-ray exposures in two planes 6., 9., 12. postoperative week, half and one year after surgery |
| OTHER | Grip Strength | Grip strength measurement |
| OTHER | VAS Score | Measurement pain according to the visual analogue scale (VAS) |
| OTHER | Range of Motion measurement | Angle measurement of the active range of motion in the wrist |
Timeline
- Start date
- 2015-01-01
- Primary completion
- 2017-07-01
- Completion
- 2017-07-01
- First posted
- 2014-12-09
- Last updated
- 2019-02-04
Locations
1 site across 1 country: Austria
Source: ClinicalTrials.gov record NCT02312128. Inclusion in this directory is not an endorsement.