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

Radius Fracture Distal Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03186963
• Other study ID #: Distalradius
• Status: Completed
• Phase: N/A
• First received: January 19, 2017
• Last updated: March 14, 2018
• Start date: May 2013
• Est. completion date: November 2017

Study information

• Verified date: March 2018
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: November 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Radius Fracture Distal
• Radius Fractures

Intervention

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

Locations

Country	Name	City	State
Brazil	Institute of Orthopedics and Traumatology - University of Sao Paulo	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of pain	Visual analogue scale for pain	12 hours
Primary	Level of pain	Visual analogue scale for pain	18 hours
Primary	Level of pain	Visual analogue scale for pain	24 hours
Primary	Level of pain	Visual analogue scale for pain	Once a day in the first week
Primary	Level of pain	Visual analogue scale for pain	2 weeks
Secondary	Level of pain	Visual analogue scale for pain	6 weeks
Secondary	Level of pain	Visual analogue scale for pain	3 months
Secondary	Level of pain	Visual analogue scale for pain	6 months
Secondary	DASH score	Disabilities of the Arm, Shoulder and Hand (DASH)	6 weeks
Secondary	DASH score	Disabilities of the Arm, Shoulder and Hand (DASH)	3 months
Secondary	DASH score	Disabilities of the Arm, Shoulder and Hand (DASH)	6 months
Secondary	Wrist flexion-extension arc	Assessed by goniometry	2 weeks
Secondary	Wrist flexion-extension arc	Assessed by goniometry	6 weeks
Secondary	Wrist flexion-extension arc	Assessed by goniometry	3 months
Secondary	Wrist flexion-extension arc	Assessed by goniometry	6 months
Secondary	Forearm rotation arc	Assessed by goniometry	2 weeks
Secondary	Forearm rotation arc	Assessed by goniometry	6 weeks
Secondary	Forearm rotation arc	Assessed by goniometry	3 months
Secondary	Forearm rotation arc	Assessed by goniometry	6 months
Secondary	Tramadol use	Percentage of patients requesting additional analgesia with tramadol in the first week	Once a day in the first week post-op
Secondary	Complication	Percentage of patients presenting with any type of local orthopedic complication	up to 24 weeks