Short Versus Conventional Plaster Cast Fixation Time in Reduced Distal Radius Fractures

Overview

The purpose of this study is to compare the radiographic and clinical outcomes after short versus conventional plaster cast fixation time in reduced distal radius fractures.

Full Title of Study: “A Comparison of Radiographic and Clinical Results After Short Versus Conventional Plaster Cast Fixation Time in Reduced Distal Radius Fractures”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2010

Detailed Description

Displaced distal radius fractures treated with closed reduction and plaster cast fixation are radiographed 10 days (range 8-13 days) after reduction and randomized to one of two study arms; immediate removal of plaster cast or continued fixation in plaster cast for another 3 weeks. Radiographic and Clinical outcome measurements at 1, 4 and 12 months

Interventions

  • Device: 10-day cast
    • Removal of plaster cast fixation 10 days after reduction

Arms, Groups and Cohorts

  • Active Comparator: 10-day cast
    • Removal of plaster cast 10 Days after reduction
  • No Intervention: 1-month cast
    • Removal of plaster cast 1 month after reduction

Clinical Trial Outcome Measures

Primary Measures

  • Radiographic displacement
    • Time Frame: At admission, 10 days, 1 month and 12 months
    • Change in dorsal angulation, radial angulation and axial compression between follow-ups.

Secondary Measures

  • Grip strength
    • Time Frame: Uninjured side. Injured side at 1, 4 , 12 months
    • Grip strength compared to uninjured side at 1, 4 and 12 months
  • Range of motion
    • Time Frame: Uninjured side. Injured side at 1, 4 and 12 months
    • Range of motion in dorsal extension, volar flexion, supination and pronation compared to uninjured side at 1, 4 and 12 months.
  • Assessment of pain intensity
    • Time Frame: 10 days, 1, 4 and 12 months
    • Average pain over the last 24 h assessed with a visual analogue scale (VAS) at 10 days, 1, 4 and 12 months
  • Assessment of functional outcome with three different functional assessment scores; 1,The modified de Bruijn wrist score 2, The modified Mayo wrist scoring chart 3, The Gartland and Werley Demerit wrist point system modified by Sarmiento.
    • Time Frame: 12 months
    • The three functional assessment scores are composite outcome measures consisting of multiple measures (results to be reported as single values for each Group),

Participating in This Clinical Trial

Inclusion Criteria

  • Distal radius fracture with intact ulna (except for processus styloideus ulnae) – Dorsal angulation 5-40 degrees – Axial compression < 4 mm – Intra articular step-off < 1 mm – Low energy trauma – Closed fracture – Suitable for treatment with closed reduction and plaster cast fixation Exclusion Criteria:

  • Fracture older than 3 Days – Previously fractured ipsi- or contralateral wrist – Dementia – Inflammatory joint disorder

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Uppsala University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Albert Christersson, MD – Uppsala University Hospital
  • Overall Official(s)
    • Albert Christersson, MD, Principal Investigator, Department of Orthopaedics, University Hospital of Uppsala

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