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Completed

NCT Number: NCT02798614

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

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.

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Key information

Conditions

Colles' Fracture Fracture Dislocation Fractures, Bone Joint Diseases Joint Dislocations Musculoskeletal Diseases Radius Fractures Wounds and Injuries

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

10-day cast

Device

Removal of plaster cast fixation 10 days after reduction

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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.

  3. 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

  4. 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),

Sponsors and collaborators

Lead sponsor

Uppsala University Hospital

Other

Registry information

Official study title

A Comparison of Radiographic and Clinical Results After Short Versus Conventional Plaster Cast Fixation Time in Reduced Distal Radius Fractures

Acronym: GitRa

Important dates

Study start
2002
Primary completion
2010
Study completion
2010
First posted
Jun 14, 2016
Registry last updated
Jun 16, 2016

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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