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Operative vs. Conservative Treatment of Distal Radius Fractures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03716661
Recruitment Status : Recruiting
First Posted : October 23, 2018
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Radius Distal Fracture Distal Radius Fracture Radius Fracture Distal Procedure: ORIF Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Operative vs. Conservative Treatment of Distal Radius Fractures
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


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

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




Primary Outcome Measures :
  1. Number of participants with treatment-related complications at baseline [ Time Frame: Baseline ]
  2. Change in number of participants with treatment-related complications from baseline at week 2 [ Time Frame: Week 2 ]
  3. Change in number of participants with treatment-related complications from baseline at week 5 [ Time Frame: Week 5 ]
  4. Change in number of participants with treatment-related complications from baseline at month 6 [ Time Frame: Month 6 ]
  5. Change in number of participants with treatment-related complications from baseline at 1 year [ Time Frame: 1 Year ]
  6. Range of motion of the wrist at week 5 [ Time Frame: 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)

  7. Change in range of motion of the wrist from week 5 at month 6 [ Time Frame: 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)

  8. Change in range of motion of the wrist from month 6 at 1 year [ Time Frame: 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)

  9. Level of functioning at baseline [ Time Frame: Baseline ]
    Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand)

  10. Change in level of functioning from baseline at week 2 [ Time Frame: Week 2 ]
    Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand)

  11. Change in level of functioning from baseline at week 5 [ Time Frame: Week 5 ]
    Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand)

  12. Change in level of functioning from baseline at month 6 [ Time Frame: Month 6 ]
    Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand)

  13. Change in level of functioning from baseline at 1 year [ Time Frame: 1 Year ]
    Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand)



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03716661


Contacts
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Contact: Rikke Thorninger, MD, consultant 004540971247 rikkthor@rm.dk

Locations
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Denmark
Regionshospitalet Randers Recruiting
Randers, Denmark, 8930
Contact: Rikke Thorninger, MD, consultant       rikkthor@rm.dk   
Sponsors and Collaborators
University of Aarhus

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03716661    
Other Study ID Numbers: 1-10-72-420-17
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries