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NCT Number: NCT06019585

Inmobilization With Compression Bandage vs Antebraquial Splint in Distal Radius Fractures

The aim of this study is to compare functional and radiological results in two groups of distal radius fractures treated with internal fixation with locking plate, and immobilized with antebrachial splint or compression bandage for 3 weeks.

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Key information

Conditions

Distal Radius Fractures Arm Injuries Fractures, Bone Internal Fixation; Complications, Mechanical Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Reina Sofía, Córdoba, Spain

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About this study

The aim of the study is to compare functional and radiological results as well as to evaluate possible complications in distal radius fractures operated by open reduction and internal fixation with volar locking plate in two groups , one treated with immobilization using a forearm cast for 3 weeks and the other with immobilization using a compression bandage for 3 weeks, based on the hypothesis that compression bandage group could obtain better results in the short term, and none of the treatments is superior to the other after 3 or 6 months of evolution, as indicated by some reviewed studies.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with type A, B, C fractures of AO classification of distal radius fractures
  • Patents aged between 18 and 75 years,
  • Patients operated on in the first 3 weeks after the trauma, and independent for the basic activities of daily living

Exclusion criteria

  • Patients with open fractures
  • Patients with mental disorders (dementia, alcoholism, etc.),
  • Patient dependent for basic activities of daily living
  • Patients with fractures with severe articular and metaphyseal comminution and/or severe soft tissue injuries (type 2R3C3 AO),
  • Patients with previous diseases or anatomical alterations in the injured wrist (previous fractures, rheumatoid arthritis, etc.).

Treatment and study plan

Splint inmmobilization

Device

After internal fixation with volar locking plate, groups of distal radius fractures are inmobilized with a plaster splint of París for 3 weeks

Bandage immovilization

Device

After internal fixation with volar locking plate, groups of distal radius fractures are inmobilized with compressive bandage for 3 weeks

Primary outcomes

  1. Pain in Visual Analogue Scale.

    Time frame: 1 year

    Points from 1 to 10. Higher score: worse value. Lower score: better value.

  2. Function in Patient Rated Wrist Evaluation Scale.

    Time frame: 1 year

    Points from 1 to 100. Higher score: worse value. Lower score: better value.

  3. Range Of Motion in Flexion.

    Time frame: 1 year

    Grades from 0 to 70. Higher score: better value. Lower score: worse value.

  4. Range Of Motion in Flexion.

    Time frame: 1 year

    Grades from 0 to 80. Higher score: better value. Lower score: worse value.

Secondary outcomes

  1. Function in Disabilities of Arm, Shoulder and Hand Scale.

    Time frame: 1 year

    Points from 1 to 150. Higher score: worse value. Lower score: better value

  2. Function in Mayo Wrist Score Scale.

    Time frame: 1 year

    Points from 1 to 100. Higher score: worse value. Lower score: better value.

  3. Range of motion in Supination.

    Time frame: 1 year

    Grades from 0 to 90. Higher score: better value. Lower score: worse value.

  4. Number of participants with posoperative complications.

    Time frame: 1 year

    Number of participants per group that suffer some complication or side effect during the follow-up period. Higher number of complications: worse value.

  5. Number of posoperative Fisiotherapy sessions performed.

    Time frame: 1 year

    Number of sessions per participant from 1 to 100. Higher score: worse value. Lower score: better value.

  6. Time of fracture union in radiographs.

    Time frame: 12 weeks

    Number of Weeks from 1 to 12. Higher score: worse value. Lower score: better value.

  7. Number of Instability distal radius fracture Criteria per participant.

    Time frame: 1 year

    Number of criteria from 1 to 6. Higher score: worse value. Lower score: better value.

  8. Grades of Dorsal Displacement in fracture.

    Time frame: 6 weeks

    Grades from -10 to 30 grades. Higher score: worse value. Lower score: better value.

  9. Range of motion in Pronation.

    Time frame: 1 year

    Grades from 0 to 90. Higher score: better value. Lower score: worse value.

  10. Range of motion in Radial Deviation

    Time frame: 1 year

    Grades from 0 to 15. Higher score: better value. Lower score: worse value.

  11. Range of motion in Ulnar deviation.

    Time frame: 1 year

    Grades from 0 to 30. Higher score: better value. Lower score: worse value.

  12. Number of shortening millimeters in fracture.

    Time frame: 6 weeks

    Number of millimeters from 0-10. Higher score: worse value. Lower score: better value.

  13. Number of ulnar variance millimeters in fracture.

    Time frame: 6 weeks

    Number of millimeters from -2 to +4. Higher score: worse value. Lower score: better value.

  14. Number of step-off millimeters in fracture.

    Time frame: 6 weeks

    Number of millimeters from 0 to 4 mm. Higher score: worse value. Lower score: better value.

Study contacts

Contact information is provided by the study sponsor or research team.

Alberto Izquierdo Fernández, Phd

CONTACT

[email protected]

+34 667789977

Jose Ignacio Miró Jiménez, MD

CONTACT

[email protected]

+34 674501958

Sponsors and collaborators

Lead sponsor

Hospital Costa del Sol

Other

Registry information

Official study title

Inmobilization With Compression Bandage vs Antebraquial Splint in Distal Radius Fractures Operated by Internal Fixation With Volar Locking Plate: A Pilot Study

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Aug 31, 2023
Registry last updated
Aug 31, 2023

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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