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

U

University of Sao Paulo

Status

Completed

Conditions

Radius Fracture Distal

Treatments

Procedure: Volar splint
Procedure: No immobilization

Study type

Interventional

Funder types

Other

Identifiers

NCT03186963
Distalradius

Details and patient eligibility

About

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.

Full 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.

Enrollment

39 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

39 participants in 2 patient groups

No immobilization
Experimental group
Description:
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.
Treatment:
Procedure: No immobilization
Volar splint
Active Comparator group
Description:
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.
Treatment:
Procedure: Volar splint

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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