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Completed

NCT Number: NCT03186963

Effectiveness of Immobilization in the Postoperative Analgesia of Surgically Treated Distal Radius Fractures

The purpose of this study is to determine wether postoperative immobilization is effective in controlling the pain of patients with intra-articular distal radius fractures treated with volar locking plate fixation. The study hypotheses is that postoperative immobilization does not enhance the analgesia of these patients.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Orthopedics and Traumatology - University of Sao Paulo

São Paulo, 05403010, Brazil

About this study

Volar locking plate fixation has been used as the gold standard treatment for intra-articular distal radius fractures. The need for postoperative immobilization after this type of fixation is controversial, with some authors advocating its use for analgesia. Conversely, the use of immobilization might retard the recovery of wrist range of motion and function. The objective of this study is to compare the level of pain and function of patients undergoing surgical fixation of distal radius fractures using or not postoperative immobilization. Patients will be randomly assigned to receive a plaster splint or conventional dressing immediately after the surgery. The main outcome is the level of pain in the first two weeks postoperatively.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Intra-articular distal radius fracture treated with volar locking plate fixation;
  • Fracture occurred within the prior 30 days;
  • Consent to participate in the study

Exclusion criteria

  • Concomitant fracture of the ipsilateral upper limb
  • Previous lesion of the ipsilateral upper limb with functional deficit
  • Bilateral fracture
  • Concomitant neurologic injury
  • Patient not amenable to follow-up

Treatment and study plan

No Immobilization

Procedure

Conventional wrist dressing

Volar Splint

Procedure

Volar plaster splint

Primary outcomes

  1. Level of pain

    Time frame: 12 hours

    Visual analogue scale for pain

  2. Level of pain

    Time frame: 18 hours

    Visual analogue scale for pain

  3. Level of pain

    Time frame: 24 hours

    Visual analogue scale for pain

  4. Level of pain

    Time frame: Once a day in the first week

    Visual analogue scale for pain

  5. Level of pain

    Time frame: 2 weeks

    Visual analogue scale for pain

Secondary outcomes

  1. Level of pain

    Time frame: 6 weeks

    Visual analogue scale for pain

  2. Level of pain

    Time frame: 3 months

    Visual analogue scale for pain

  3. Level of pain

    Time frame: 6 months

    Visual analogue scale for pain

  4. DASH score

    Time frame: 6 weeks

    Disabilities of the Arm, Shoulder and Hand (DASH)

  5. DASH score

    Time frame: 3 months

    Disabilities of the Arm, Shoulder and Hand (DASH)

  6. DASH score

    Time frame: 6 months

    Disabilities of the Arm, Shoulder and Hand (DASH)

  7. Wrist flexion-extension arc

    Time frame: 2 weeks

    Assessed by goniometry

  8. Wrist flexion-extension arc

    Time frame: 6 weeks

    Assessed by goniometry

  9. Wrist flexion-extension arc

    Time frame: 3 months

    Assessed by goniometry

  10. Wrist flexion-extension arc

    Time frame: 6 months

    Assessed by goniometry

  11. Forearm rotation arc

    Time frame: 2 weeks

    Assessed by goniometry

  12. Forearm rotation arc

    Time frame: 6 weeks

    Assessed by goniometry

  13. Forearm rotation arc

    Time frame: 3 months

    Assessed by goniometry

  14. Forearm rotation arc

    Time frame: 6 months

    Assessed by goniometry

  15. Tramadol use

    Time frame: Once a day in the first week post-op

    Percentage of patients requesting additional analgesia with tramadol in the first week

  16. Complication

    Time frame: up to 24 weeks

    Percentage of patients presenting with any type of local orthopedic complication

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Effectiveness of Immobilization in the Postoperative Analgesia of Patients With Distal Radius Fracture Treated With Volar Locking Plating: a Prospective, Randomized Clinical Trial

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jun 14, 2017
Registry last updated
Mar 16, 2018

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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