Operative vs. Conservative Treatment of Distal Radius Fractures

Study Overview
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Brief Summary
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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.

Official Title
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Operative vs. Conservative Treatment of Distal Radius Fractures

Conditions
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Radius Distal Fracture, Distal Radius Fracture, Radius Fracture Distal

Intervention / Treatment
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* Procedure: ORIF


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Arm 1/control group: Participants who are treated with conservative plaster following National Clinical Guidelines. | |
| No Intervention: Conservative<br>Arm 2 and 3 consist of participants fulfilling the criteria for operative treatment following National Clinical Guidelines. Arm 2: Patients randomized to conservative plaster treatment | |
| Other: Operative<br>Arm 2 and 3 consist of participants fulfilling the criteria for operative treatment following National Clinical Guidelines. Arm 3: Patients randomized to operative treatment (ORIF) | Procedure: ORIF<br>* Open Reduction Internal Fixation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | Week 5 | 
| Change in range of motion of the wrist from week 5 at 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) | Month 6 | 
| Change in range of motion of the wrist from month 6 at 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) | 1 Year | 
| Level of functioning at baseline | Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand) | Baseline | 
| Change in level of functioning from baseline at week 2 | Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand) | Week 2 | 
| Change in level of functioning from baseline at week 5 | Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand) | Week 5 | 
| Change in level of functioning from baseline at month 6 | Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand) | Month 6 | 
| Change in level of functioning from baseline at 1 year | Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand) | 1 Year |