Radius Distal Fracture, Distal Radius Fracture, Radius Fracture Distal
Conditions
Brief summary
Even though broken wrists are of frequent occurrence, the investigators see a lack of extensive and well executed international studies to clarify which is the best treatment for elderly participants at 65+ years. The Danish Health and Medicines Authority recommend that broken wrists are treated with surgery by using plates and screws when certain radiological criteria are met. Recent studies show that, apparently, there are no advantages by operating rather than treating with plaster when comparing the functional results after one year. However, there is a 30 % risk of serious complications occurring after surgery. This study will examine the pros and cons that participants at 65+ years with broken wrists experience after, by lot, having been treated with either surgery (using plates and screws) or without surgery (using plaster for 5 weeks). The purpose of this study is to compare the complications and level of functioning between participants treated with surgery and without surgery.
Interventions
PROCEDUREORIF
Open Reduction Internal Fixation
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Danish National Guidelines for operative treatment of distal radius fractures
Exclusion criteria
* Patients treated with plaster in Arm1/control group who unexpectedly requires surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Level of functioning at baseline | Baseline | Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand) |
| Change in level of functioning from baseline at week 2 | Week 2 | Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand) |
| Change in level of functioning from baseline at week 5 | Week 5 | Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand) |
| Change in level of functioning from baseline at month 6 | Month 6 | Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand) |
| Number of participants with treatment-related complications at baseline | Baseline | — |
| Change in number of participants with treatment-related complications from baseline at week 2 | Week 2 | — |
| Change in number of participants with treatment-related complications from baseline at week 5 | Week 5 | — |
| Change in number of participants with treatment-related complications from baseline at month 6 | Month 6 | — |
| Change in number of participants with treatment-related complications from baseline at 1 year | 1 Year | — |
| Range of motion of the wrist at week 5 | Week 5 | a. Flexion (0-90 degrees) b. Extension (0-75 degrees) c. Pronation (0-90 degrees) d. Supination (0-90 degrees) e. Radial flexion (0-25 degrees) f. Ulnar flexion (0-50 degrees) |
| Change in range of motion of the wrist from week 5 at month 6 | Month 6 | a. Flexion (0-90 degrees) b. Extension (0-75 degrees) c. Pronation (0-90 degrees) d. Supination (0-90 degrees) e. Radial flexion (0-25 degrees) f. Ulnar flexion (0-50 degrees) |
| Change in range of motion of the wrist from month 6 at 1 year | 1 Year | a. Flexion (0-90 degrees) b. Extension (0-75 degrees) c. Pronation (0-90 degrees) d. Supination (0-90 degrees) e. Radial flexion (0-25 degrees) f. Ulnar flexion (0-50 degrees) |
| Change in level of functioning from baseline at 1 year | 1 Year | Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand) |
Countries
Denmark
Outcome results
None listed