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NCT03716661 Clinical Trial

Operative vs. Conservative Treatment of Distal Radius Fractures

Distal Radius Fracture Clinical Trial

Official title:
Operative vs. Conservative Treatment of Distal Radius Fractures

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03716661
Other study ID # 1-10-72-420-17
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2018
Est. completion date April 1, 2022

Study information
Verified date May 2022
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date April 1, 2022
Est. primary completion date April 1, 2022
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• ORIF
Open Reduction Internal Fixation

Locations
Country Name City State
Denmark Regionshospitalet Randers Randers

Sponsors (1)
Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants with treatment-related complications at baseline Baseline
Primary Change in number of participants with treatment-related complications from baseline at week 2 Week 2
Primary Change in number of participants with treatment-related complications from baseline at week 5 Week 5
Primary Change in number of participants with treatment-related complications from baseline at month 6 Month 6
Primary Change in number of participants with treatment-related complications from baseline at 1 year 1 Year
Primary 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
Primary 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
Primary 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
Primary Level of functioning at baseline Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand) Baseline
Primary Change in level of functioning from baseline at week 2 Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand) Week 2
Primary Change in level of functioning from baseline at week 5 Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand) Week 5
Primary Change in level of functioning from baseline at month 6 Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand) Month 6
Primary Change in level of functioning from baseline at 1 year Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand) 1 Year
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