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

Sponsor

University of Sao Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT03186963

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Radius Fracture Distal	Procedure: No immobilization Procedure: Volar splint	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

39 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

May 1, 2013

Actual Primary Completion Date :

Jun 1, 2017

Actual Study Completion Date :

Nov 1, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Level of pain [12 hours]
Visual analogue scale for pain
Level of pain [18 hours]
Visual analogue scale for pain
Level of pain [24 hours]
Visual analogue scale for pain
Level of pain [Once a day in the first week]
Visual analogue scale for pain
Level of pain [2 weeks]
Visual analogue scale for pain

Secondary Outcome Measures

Level of pain [6 weeks]
Visual analogue scale for pain
Level of pain [3 months]
Visual analogue scale for pain
Level of pain [6 months]
Visual analogue scale for pain
DASH score [6 weeks]
Disabilities of the Arm, Shoulder and Hand (DASH)
DASH score [3 months]
Disabilities of the Arm, Shoulder and Hand (DASH)
DASH score [6 months]
Disabilities of the Arm, Shoulder and Hand (DASH)
Wrist flexion-extension arc [2 weeks]
Assessed by goniometry
Wrist flexion-extension arc [6 weeks]
Assessed by goniometry
Wrist flexion-extension arc [3 months]
Assessed by goniometry
Wrist flexion-extension arc [6 months]
Assessed by goniometry
Forearm rotation arc [2 weeks]
Assessed by goniometry
Forearm rotation arc [6 weeks]
Assessed by goniometry
Forearm rotation arc [3 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Orthopedics and Traumatology - University of Sao Paulo	Sao Paulo	SP	Brazil	05403010

Sponsors and Collaborators

University of Sao Paulo

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fernando B Andrade-Silva, MD, Principal Investigator, University of Sao Paulo

ClinicalTrials.gov Identifier:

NCT03186963

Other Study ID Numbers:

Distalradius

First Posted:

Jun 14, 2017

Last Update Posted:

Mar 16, 2018

Last Verified:

Mar 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Fernando B Andrade-Silva, MD, Principal Investigator, University of Sao Paulo

distal radius fracture

volar plate

immobilization

Additional relevant MeSH terms:

Fractures, Bone

Radius Fractures

Study Results

No Results Posted as of Mar 16, 2018