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Operative vs. Conservative Treatment of Distal Radius Fractures

Primary Purpose

Radius Distal Fracture, Distal Radius Fracture, Radius Fracture Distal

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
ORIF
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radius Distal Fracture

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Regionshospitalet Randers

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

No Intervention

Other

Arm Label

Control

Conservative

Operative

Arm Description

Arm 1/control group: Participants who are treated with conservative plaster following National Clinical Guidelines.

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

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)

Outcomes

Primary Outcome Measures

Number of participants with treatment-related complications at baseline
Change in number of participants with treatment-related complications from baseline at week 2
Change in number of participants with treatment-related complications from baseline at week 5
Change in number of participants with treatment-related complications from baseline at month 6
Change in number of participants with treatment-related complications from baseline at 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)
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)
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)
Level of functioning at baseline
Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand)
Change in level of functioning from baseline at week 2
Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand)
Change in level of functioning from baseline at week 5
Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand)
Change in level of functioning from baseline at month 6
Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand)
Change in level of functioning from baseline at 1 year
Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand)

Secondary Outcome Measures

Full Information

First Posted
October 5, 2018
Last Updated
August 9, 2022
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT03716661
Brief Title
Operative vs. Conservative Treatment of Distal Radius Fractures
Official Title
Operative vs. Conservative Treatment of Distal Radius Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
April 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radius Distal Fracture, Distal Radius Fracture, Radius Fracture Distal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Arm 1/control group: Participants who are treated with conservative plaster following National Clinical Guidelines.
Arm Title
Conservative
Arm Type
No Intervention
Arm Description
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
Arm Title
Operative
Arm Type
Other
Arm Description
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)
Intervention Type
Procedure
Intervention Name(s)
ORIF
Intervention Description
Open Reduction Internal Fixation
Primary Outcome Measure Information:
Title
Number of participants with treatment-related complications at baseline
Time Frame
Baseline
Title
Change in number of participants with treatment-related complications from baseline at week 2
Time Frame
Week 2
Title
Change in number of participants with treatment-related complications from baseline at week 5
Time Frame
Week 5
Title
Change in number of participants with treatment-related complications from baseline at month 6
Time Frame
Month 6
Title
Change in number of participants with treatment-related complications from baseline at 1 year
Time Frame
1 Year
Title
Range of motion of the wrist at week 5
Description
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)
Time Frame
Week 5
Title
Change in range of motion of the wrist from week 5 at month 6
Description
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)
Time Frame
Month 6
Title
Change in range of motion of the wrist from month 6 at 1 year
Description
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)
Time Frame
1 Year
Title
Level of functioning at baseline
Description
Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand)
Time Frame
Baseline
Title
Change in level of functioning from baseline at week 2
Description
Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand)
Time Frame
Week 2
Title
Change in level of functioning from baseline at week 5
Description
Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand)
Time Frame
Week 5
Title
Change in level of functioning from baseline at month 6
Description
Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand)
Time Frame
Month 6
Title
Change in level of functioning from baseline at 1 year
Description
Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand)
Time Frame
1 Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Regionshospitalet Randers
City
Randers
ZIP/Postal Code
8930
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
31253145
Citation
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.
Results Reference
derived

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Operative vs. Conservative Treatment of Distal Radius Fractures

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