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Completed

NCT Number: NCT05558306

Radiological vs Clinical Outcome in DRF

Background: Several studies have investigated the degree of final displacement and its association with clinical outcome. There is still no consensus on the importance of radiological outcome and published studies do not use the same criteria for an acceptable alignment. Previous reports have used a linear or a dichotomized exposure in the statistical analysis, but no study has investigated a nonlinear association.

Methods: We included 438 patients treated for a distal radius fracture (DRF) with either reduction and cast immobilization or surgery. Radiographic outcomes were determined by radiographs 3 months after the injury. Clinical outcome was determined by QuickDASH (qDASH), ROM and grip strength at 1-year after the injury. Nonlinear correlations were analysed with cubic splines.

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Key information

Conditions

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

Age range

15 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with distal radius fracture between 15 and 74 years, with closed physes of the distal radius and ulna.

Exclusion criteria

  • Dementia
  • Previous fracture to the ipsilateral wrist
  • Open fracture
  • Other concomitant or existing damage or injury to the wrist
  • Galeazzi fracture
  • Rheumatoid arthritis
  • Alcohol or drug abuse
  • Neurologic impairment

Treatment and study plan

Surgery of distal radius fracture

Procedure

Surgery of distal radius fracture for displaced fractures

Reduction and cast treatment of distal radius fracture

Procedure

Reduction and cast treatment of distal radius fracture for minimally displaced fractures

Primary outcomes

  1. quickDASH

    Time frame: 12 months

    The DASH is a 30-item PROM questionnaire that evaluates the upper extremity [115]. The qDASH is a shortened version with 11 questions that can be used instead of the full 30-item questionnaire [114]. Both are validated for use in upper extremity disorders [114,115]. Neither is specific for wrist function and both yield scores from 0 to 100, where lower scores indicate a better outcome.

  2. Range of motion

    Time frame: 12 months

    The active ROM of the radiocarpal joint and the radioulnar joints were measured in both hands using a standard goniometer. The arcs of flexion-extension, pronation-supination and radial-ulnar deviation were recorded. Total ROM was calculated as the sum of these three arcs. The loss of ROM in the fractured wrist was expressed in angular degrees compared to the contralateral uninjured wrist [126].

    Independent occupational therapists, blinded to the radiological outcome, measured objective function, including grip strength and active ROM.

  3. Grip strength

    Time frame: 12 months

    Grip strength was measured in a sitting position with the elbow in 90° of flexion, neutral rotation and wrist 0°-30° extension using a JAMAR dynamometer [122]. To prevent it from falling, the examiner may support the JAMAR dynamometer. Both hands are examined, starting with the uninjured hand. Three strength tests were conducted during the assessment of grip strength, with the mean score of the three tests recorded for analysis. Grip strength was adjusted by 10% for the non-dominant hand [123]. The contralateral wrist was used as an internal control. Grip strength was expressed as a percentage (the ratio to the uninjured wrist) and the absolute loss in kilograms comparing the fractured wrist to the uninjured wrist.

    Independent occupational therapists, blinded to the radiological outcome, measured objective function, including grip strength and active ROM.

Sponsors and collaborators

Lead sponsor

Sundsvall Hospital

Other

Registry information

Official study title

Association Between Radiographic and Clinical Outcome in Distal Radius Fractures: A Prospective Cohort Study With a 1-year Follow-up in 368 Patients

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 28, 2022
Registry last updated
Sep 28, 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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