Effectiveness of Immobilization in the Postoperative Analgesia of Surgically Treated Distal Radius Fractures
1 other identifier
interventional
39
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedFirst Posted
Study publicly available on registry
June 14, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2017
CompletedMarch 16, 2018
March 1, 2018
4.1 years
January 19, 2017
March 14, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Level of pain
Visual analogue scale for pain
12 hours
Level of pain
Visual analogue scale for pain
18 hours
Level of pain
Visual analogue scale for pain
24 hours
Level of pain
Visual analogue scale for pain
Once a day in the first week
Level of pain
Visual analogue scale for pain
2 weeks
Secondary Outcomes (16)
Level of pain
6 weeks
Level of pain
3 months
Level of pain
6 months
DASH score
6 weeks
DASH score
3 months
- +11 more secondary outcomes
Study Arms (2)
No immobilization
EXPERIMENTALPatients 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.
Volar splint
ACTIVE COMPARATORPatients 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.
Interventions
Eligibility Criteria
You may qualify if:
- Intra-articular distal radius fracture treated with volar locking plate fixation;
- Fracture occurred within the prior 30 days;
- Consent to participate in the study
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Orthopedics and Traumatology - University of Sao Paulo
São Paulo, São Paulo, 05403010, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Kodi E Kojima, MD
Institute of Orthopedics - University of Sao Paulo
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 19, 2017
First Posted
June 14, 2017
Study Start
May 1, 2013
Primary Completion
June 1, 2017
Study Completion
November 1, 2017
Last Updated
March 16, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share