Operative vs. Conservative Treatment of Distal Radius Fractures

Not Applicable

Completed

• Conditions: Distal Radius Fracture; Radius Distal Fracture; Radius Fracture Distal
• Interventions: Procedure: ORIF

• Registration Number: NCT03716661
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-05
• Study First Submitted QC: 2018-10-22
• Study First Posted: 2018-10-23
• Study Start: 2018-11-01
• Primary Completion: 2022-04-01
• Study Completion: 2022-04-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-08-09
• Last Update Posted: 2022-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Danish National Guidelines for operative treatment of distal radius fractures

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Exclusion Criteria

• Patients treated with plaster in Arm1/control group who unexpectedly requires surgery

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Operative	ORIF	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)

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment-related complications at baseline	Baseline
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 number of participants with treatment-related complications from baseline at week 2	Week 2
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 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 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)
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)
Change in level of functioning from baseline at 1 year	1 Year	Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand)

Trial Locations

Locations (1)

Regionshospitalet Randers; 🇩🇰 Randers, Denmark