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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: June 2017

Detailed Description

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.

Interventions

  • Procedure: No immobilization
    • Conventional wrist dressing
  • Procedure: Volar splint
    • Volar plaster splint

Arms, Groups and Cohorts

  • Experimental: No immobilization
    • Patients receive a conventional dressing made with gauze, cotton padding and inelastic bandage after the surgery. They are instructed to start light wrist movements on the first postoperative day and progress as tolerated, beginning rehabilitation with physiotherapy after 2 weeks postoperatively.
  • Active Comparator: Volar splint
    • Patients receive a volar plaster splint with inelastic bandage after the surgery, and are instructed not to remove the immobilization for 2 weeks. After this period, the immobilization is removed and patients begin rehabilitation with physiotherapy.

Clinical Trial Outcome Measures

Primary Measures

  • Level of pain
    • Time Frame: 12 hours
    • Visual analogue scale for pain
  • Level of pain
    • Time Frame: 18 hours
    • Visual analogue scale for pain
  • Level of pain
    • Time Frame: 24 hours
    • Visual analogue scale for pain
  • Level of pain
    • Time Frame: Once a day in the first week
    • Visual analogue scale for pain
  • Level of pain
    • Time Frame: 2 weeks
    • Visual analogue scale for pain

Secondary Measures

  • Level of pain
    • Time Frame: 6 weeks
    • Visual analogue scale for pain
  • Level of pain
    • Time Frame: 3 months
    • Visual analogue scale for pain
  • Level of pain
    • Time Frame: 6 months
    • Visual analogue scale for pain
  • DASH score
    • Time Frame: 6 weeks
    • Disabilities of the Arm, Shoulder and Hand (DASH)
  • DASH score
    • Time Frame: 3 months
    • Disabilities of the Arm, Shoulder and Hand (DASH)
  • DASH score
    • Time Frame: 6 months
    • Disabilities of the Arm, Shoulder and Hand (DASH)
  • Wrist flexion-extension arc
    • Time Frame: 2 weeks
    • Assessed by goniometry
  • Wrist flexion-extension arc
    • Time Frame: 6 weeks
    • Assessed by goniometry
  • Wrist flexion-extension arc
    • Time Frame: 3 months
    • Assessed by goniometry
  • Wrist flexion-extension arc
    • Time Frame: 6 months
    • Assessed by goniometry
  • Forearm rotation arc
    • Time Frame: 2 weeks
    • Assessed by goniometry
  • Forearm rotation arc
    • Time Frame: 6 weeks
    • Assessed by goniometry
  • Forearm rotation arc
    • Time Frame: 3 months
    • Assessed by goniometry
  • Forearm rotation arc
    • Time Frame: 6 months
    • Assessed by goniometry
  • 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
  • Complication
    • Time Frame: up to 24 weeks
    • Percentage of patients presenting with any type of local orthopedic complication

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Sao Paulo
  • Provider of Information About this Clinical Study
    • Principal Investigator: Fernando B Andrade-Silva, MD, Principal Investigator – University of Sao Paulo
  • Overall Official(s)
    • Kodi E Kojima, MD, Study Chair, Institute of Orthopedics – University of Sao Paulo

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.