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

Primary Purpose

Radius Fracture Distal

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
No immobilization
Volar splint
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radius Fracture Distal focused on measuring distal radius fracture, volar plate, immobilization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Orthopedics and Traumatology - University of Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

No immobilization

Volar splint

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Level of pain
Visual analogue scale for pain
Level of pain
Visual analogue scale for pain
Level of pain
Visual analogue scale for pain
Level of pain
Visual analogue scale for pain
Level of pain
Visual analogue scale for pain

Secondary Outcome Measures

Level of pain
Visual analogue scale for pain
Level of pain
Visual analogue scale for pain
Level of pain
Visual analogue scale for pain
DASH score
Disabilities of the Arm, Shoulder and Hand (DASH)
DASH score
Disabilities of the Arm, Shoulder and Hand (DASH)
DASH score
Disabilities of the Arm, Shoulder and Hand (DASH)
Wrist flexion-extension arc
Assessed by goniometry
Wrist flexion-extension arc
Assessed by goniometry
Wrist flexion-extension arc
Assessed by goniometry
Wrist flexion-extension arc
Assessed by goniometry
Forearm rotation arc
Assessed by goniometry
Forearm rotation arc
Assessed by goniometry
Forearm rotation arc
Assessed by goniometry
Forearm rotation arc
Assessed by goniometry
Tramadol use
Percentage of patients requesting additional analgesia with tramadol in the first week
Complication
Percentage of patients presenting with any type of local orthopedic complication

Full Information

First Posted
January 19, 2017
Last Updated
March 14, 2018
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT03186963
Brief Title
Effectiveness of Immobilization in the Postoperative Analgesia of Surgically Treated Distal Radius Fractures
Official Title
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
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radius Fracture Distal
Keywords
distal radius fracture, volar plate, immobilization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No immobilization
Arm Type
Experimental
Arm Description
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.
Arm Title
Volar splint
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
No immobilization
Intervention Description
Conventional wrist dressing
Intervention Type
Procedure
Intervention Name(s)
Volar splint
Intervention Description
Volar plaster splint
Primary Outcome Measure Information:
Title
Level of pain
Description
Visual analogue scale for pain
Time Frame
12 hours
Title
Level of pain
Description
Visual analogue scale for pain
Time Frame
18 hours
Title
Level of pain
Description
Visual analogue scale for pain
Time Frame
24 hours
Title
Level of pain
Description
Visual analogue scale for pain
Time Frame
Once a day in the first week
Title
Level of pain
Description
Visual analogue scale for pain
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Level of pain
Description
Visual analogue scale for pain
Time Frame
6 weeks
Title
Level of pain
Description
Visual analogue scale for pain
Time Frame
3 months
Title
Level of pain
Description
Visual analogue scale for pain
Time Frame
6 months
Title
DASH score
Description
Disabilities of the Arm, Shoulder and Hand (DASH)
Time Frame
6 weeks
Title
DASH score
Description
Disabilities of the Arm, Shoulder and Hand (DASH)
Time Frame
3 months
Title
DASH score
Description
Disabilities of the Arm, Shoulder and Hand (DASH)
Time Frame
6 months
Title
Wrist flexion-extension arc
Description
Assessed by goniometry
Time Frame
2 weeks
Title
Wrist flexion-extension arc
Description
Assessed by goniometry
Time Frame
6 weeks
Title
Wrist flexion-extension arc
Description
Assessed by goniometry
Time Frame
3 months
Title
Wrist flexion-extension arc
Description
Assessed by goniometry
Time Frame
6 months
Title
Forearm rotation arc
Description
Assessed by goniometry
Time Frame
2 weeks
Title
Forearm rotation arc
Description
Assessed by goniometry
Time Frame
6 weeks
Title
Forearm rotation arc
Description
Assessed by goniometry
Time Frame
3 months
Title
Forearm rotation arc
Description
Assessed by goniometry
Time Frame
6 months
Title
Tramadol use
Description
Percentage of patients requesting additional analgesia with tramadol in the first week
Time Frame
Once a day in the first week post-op
Title
Complication
Description
Percentage of patients presenting with any type of local orthopedic complication
Time Frame
up to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kodi E Kojima, MD
Organizational Affiliation
Institute of Orthopedics - University of Sao Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Institute of Orthopedics and Traumatology - University of Sao Paulo
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403010
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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

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