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OpenTrials
Completed

NCT Number: NCT03716661

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.

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Key information

Conditions

Radius Distal Fracture Arm Injuries Distal Radius Fracture Fractures, Bone Radius Fracture Distal Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Regionshospitalet Randers

Randers, 8930, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ORIF

Procedure

Open Reduction Internal Fixation

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Oct 23, 2018
Registry last updated
Aug 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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