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Completed

NCT Number: NCT05370365

Four or Six Weeks of Immobilization in the Conservative Treatment of Distal Radius Fractures in Elderly Population?

The purpose of this study is to compare if there are differences in wrist function and pain after a distal radius fracture treated conservatively with immobilization for 4 or 6 weeks in elderly patients after six months of follow-up.

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Key information

Conditions

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

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital del Mar

Barcelona, 08021, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients older than 65 years with a low energy distal radius fracture
  • Intra or extraarticular distal radius fracture (A2, A3, C1, C2)
  • Acceptable primary reduction (dorsal inclination <10º, radial shortening <3mm, articular gap <2mm)

Exclusion criteria

  • History of ipsilateral fracture
  • Bilateral fracture
  • Open fracture
  • Other concomitant fracture (except ulnar styloid fracture)
  • Fracture AO B
  • Previous surgeries in this area
  • Dementia

Treatment and study plan

Below elbow cast

Procedure

Patients will be stay with a below elbow cast for 4 or 6 weeks

Primary outcomes

  1. Patient Rated Wrist Evaluation (PRWE)

    Time frame: 3 months

    The PRWE is a 15-item questionnaire designed to measure pain and wrist disability in activities of daily living.

  2. Patient Rated Wrist Evaluation (PRWE)

    Time frame: 6 months

    The PRWE is a 15-item questionnaire designed to measure pain and wrist disability in activities of daily living.

  3. Patient Rated Wrist Evaluation (PRWE)

    Time frame: 1 year

    The PRWE is a 15-item questionnaire designed to measure pain and wrist disability in activities of daily living.

Secondary outcomes

  1. Quick Disability of Arm and Shoulder (QuickDASH)

    Time frame: 3 months

    It is a questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale.

  2. Quick Disability of Arm and Shoulder (QuickDASH)

    Time frame: 6 months

    It is a questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale.

  3. Quick Disability of Arm and Shoulder (QuickDASH)

    Time frame: 1 year

    It is a questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale.

  4. Visual Analogue Scale (VAS)

    Time frame: 3 months

    is a measuring instrument that tries to measure the amount of pain a patient feels, which is supposed to be a value that oscillates in a continuous between no pain and an extreme amount of pain.

  5. Visual Analogue Scale (VAS)

    Time frame: 6 months

    is a measuring instrument that tries to measure the amount of pain a patient feels, which is supposed to be a value that oscillates in a continuous between no pain and an extreme amount of pain.

  6. Visual Analogue Scale (VAS)

    Time frame: 1 year

    is a measuring instrument that tries to measure the amount of pain a patient feels, which is supposed to be a value that oscillates in a continuous between no pain and an extreme amount of pain.

  7. Range Of Movement (ROM)

    Time frame: 3 months

    Flexion, Extension, radial and ulnar deviation

  8. Range Of Movement (ROM)

    Time frame: 6 months

    Flexion, Extension, radial and ulnar deviation

  9. Range Of Movement (ROM)

    Time frame: 1 year

    Flexion, Extension, radial and ulnar deviation

  10. Complications

    Time frame: 1 year

    Stiffness, delayed and non-union and complex regional pain syndrome (CRPS).

Sponsors and collaborators

Lead sponsor

Parc de Salut Mar

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2024
First posted
May 11, 2022
Registry last updated
Jun 3, 2025

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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