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

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

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.

Study Overview

• Status: Completed
• Conditions: Radius Fracture Distal
• Intervention / Treatment: Procedure: No immobilization; Procedure: Volar splint

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.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 05403010
      • Institute of Orthopedics and Traumatology - University of Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Procedure: No immobilization; Conventional wrist dressing
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.	Procedure: Volar splint; Volar plaster splint

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of pain	Visual analogue scale for pain	6 weeks
Level of pain	Visual analogue scale for pain	3 months
Level of pain	Visual analogue scale for pain	6 months
DASH score	Disabilities of the Arm, Shoulder and Hand (DASH)	6 weeks
DASH score	Disabilities of the Arm, Shoulder and Hand (DASH)	3 months
DASH score	Disabilities of the Arm, Shoulder and Hand (DASH)	6 months
Wrist flexion-extension arc	Assessed by goniometry	2 weeks
Wrist flexion-extension arc	Assessed by goniometry	6 weeks
Wrist flexion-extension arc	Assessed by goniometry	3 months
Wrist flexion-extension arc	Assessed by goniometry	6 months
Forearm rotation arc	Assessed by goniometry	2 weeks
Forearm rotation arc	Assessed by goniometry	6 weeks
Forearm rotation arc	Assessed by goniometry	3 months
Forearm rotation arc	Assessed by goniometry	6 months
Tramadol use	Percentage of patients requesting additional analgesia with tramadol in the first week	Once a day in the first week post-op
Complication	Percentage of patients presenting with any type of local orthopedic complication	up to 24 weeks

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Study Chair: Kodi E Kojima, MD, Institute of Orthopedics - University of Sao Paulo

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: January 19, 2017
• First Submitted That Met QC Criteria: June 12, 2017
• First Posted (Actual): June 14, 2017

Study Record Updates

• Last Update Posted (Actual): March 16, 2018
• Last Update Submitted That Met QC Criteria: March 14, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: distal radius fracture; immobilization; volar plate
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Radius Fractures
• Other Study ID Numbers: Distalradius

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No