Radiological vs Clinical Outcome in DRF

Distal Radius Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05558306
• Other study ID #: VS_DRF_Outcome
• Status: Completed
• Phase: N/A
• Start date: October 2009
• Est. completion date: September 2011

Study information

• Verified date: September 2022
• Source: Sundsvall Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 451
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Distal Radius Fracture
• Radius Fractures

Intervention

Procedure:
• Surgery of distal radius fracture
Surgery of distal radius fracture for displaced fractures
• Reduction and cast treatment of distal radius fracture
Reduction and cast treatment of distal radius fracture for minimally displaced fractures

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sundsvall Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quickDASH	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.	12 months
Primary	Range of motion	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.	12 months
Primary	Grip strength	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.	12 months