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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03186963
Other study ID # Distalradius
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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