Radiological vs Clinical Outcome in DRF

NCT05558306 | Completed

• 1 other identifier: VS_DRF_Outcome
• Study Type: interventional
• Target: 451
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Distal Radius Fracture

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

Treatment protocol

OTHER

All patients were treated according to the treatment protocol with cast for minimally displaced fractures and surgery for displaced fractures.

Procedure: Surgery of distal radius fracture; Procedure: Reduction and cast treatment of distal radius fracture

Interventions

Surgery of distal radius fracture PROCEDURE

Surgery of distal radius fracture for displaced fractures

Treatment protocol

Reduction and cast treatment of distal radius fracture PROCEDURE

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

Treatment protocol

Eligibility Criteria

• Age: 15 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sundsvall Hospital: lead

Related Publications (1)

• Schmidt V, Gordon M, Tagil M, Sayed-Noor A, Mukka S, Wadsten M. Association Between Radiographic and Clinical Outcomes Following Distal Radial Fractures: A Prospective Cohort Study with 1-Year Follow-up in 366 Patients. J Bone Joint Surg Am. 2023 Aug 2;105(15):1156-1167. doi: 10.2106/JBJS.22.01096. Epub 2023 May 12.

  PMID: 37172109 DERIVED

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 28, 2022
• Study Start: October 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: September 28, 2022

Record last verified: 2022-09