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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03186963
Enrollment
39
Registered
2017-06-14
Start date
2013-05-31
Completion date
2017-11-30
Last updated
2018-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radius Fracture Distal

Keywords

distal radius fracture, volar plate, immobilization

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.

Interventions

Conventional wrist dressing

PROCEDUREVolar splint

Volar plaster splint

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Level of pain12 hoursVisual analogue scale for pain

Secondary

MeasureTime frameDescription
Level of pain6 weeksVisual analogue scale for pain
Wrist flexion-extension arc2 weeksAssessed by goniometry
DASH score6 weeksDisabilities of the Arm, Shoulder and Hand (DASH)
Tramadol useOnce a day in the first week post-opPercentage of patients requesting additional analgesia with tramadol in the first week
Complicationup to 24 weeksPercentage of patients presenting with any type of local orthopedic complication
Forearm rotation arc2 weeksAssessed by goniometry

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026