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

Not Applicable

Completed

• Conditions: Radius Fracture Distal
• Interventions: Procedure: No immobilization; Procedure: Volar splint

• Registration Number: NCT03186963
• Lead Sponsor: University of Sao Paulo

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2017-01-19
• Primary Completion: 2017-06
• Study First Submitted QC: 2017-06-12
• Study First Posted: 2017-06-14
• Study Completion: 2017-11
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-14
• Last Update Posted: 2018-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No immobilization	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.
Volar splint	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.

Primary Outcome Measures

Name	Time	Method
Level of pain	2 weeks	Visual analogue scale for pain

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Institute of Orthopedics and Traumatology - University of Sao Paulo; 🇧🇷 Sao Paulo, SP, Brazil