Operative vs. Conservative Treatment of Distal Radius Fractures

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.

Study Overview

• Status: Completed
• Conditions: Distal Radius Fracture; Radius Fracture Distal; Radius Distal Fracture
• Intervention / Treatment: Procedure: ORIF

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Randers, Denmark, 8930
    • Regionshospitalet Randers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 61 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Arm 1/control group: Participants who are treated with conservative plaster following National Clinical Guidelines.
No Intervention: Conservative; 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; 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; Open Reduction Internal Fixation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Aarhus

Publications and helpful links

General Publications

• Pedersen J, Mortensen SO, Rolfing JD, Thorninger R. A protocol for a single-center, single-blinded randomized-controlled trial investigating volar plating versus conservative treatment of unstable distal radius fractures in patients older than 65 years. BMC Musculoskelet Disord. 2019 Jun 29;20(1):309. doi: 10.1186/s12891-019-2677-y.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): April 1, 2022
• Study Completion (Actual): April 1, 2022

Study Registration Dates

• First Submitted: October 5, 2018
• First Submitted That Met QC Criteria: October 22, 2018
• First Posted (Actual): October 23, 2018

Study Record Updates

• Last Update Posted (Actual): August 10, 2022
• Last Update Submitted That Met QC Criteria: August 9, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Radius Fractures
• Other Study ID Numbers: 1-10-72-420-17

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No