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

NCT ID: NCT03186963

Last Updated: 2018-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2017-11-30

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.

Conditions

Radius Fracture Distal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

No immobilization

Intervention Type: PROCEDURE

Conventional wrist dressing

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.

Group Type: ACTIVE_COMPARATOR

Volar splint

Intervention Type: PROCEDURE

Volar plaster splint

Interventions

No immobilization

Conventional wrist dressing

Intervention Type: PROCEDURE

Volar splint

Volar plaster splint

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Fernando B Andrade-Silva, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kodi E Kojima, MD

Role: STUDY_CHAIR

Institute of Orthopedics - University of Sao Paulo

Locations

Institute of Orthopedics and Traumatology - University of Sao Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

Distalradius

Identifier Type: -

Identifier Source: org_study_id