Headless Screws x Bouquet in Boxer's Fracture
Headless Screws Versus Bouquet in Intramedullar Fixation of Boxer's Fracture: A Randomized Clinical Trial
1 other identifier
interventional
24
1 country
1
Brief Summary
Despite the high prevalence (20% of the hand fractures) of unstable neck metacarpals fractures (boxer's fractures) there is still no consensus concerning the preferred method and ideal moment of treatment, especially in active patients where the time or type of management can have a strong psychological impact on the outcomes. The use of intramedullar technique (headless intramedular screws or bouquet technique fixation) as definitive treatment of unstable boxer's fractures in active patients at the first week, may be a good choice of treatment. This technique is fast, safe, minimally invasive and easily performed reproducible method, without address the extensor tendon to prevent tendon adhesion and joint stiffness, unable earlier functional recovery and shorten the working return time of these patients. Choose a reproducible and effective method, which presents a cost / benefit compatible with our reality. The goal of the present study is to compare working return time, VAS (visual analogue score), quick DASH (disability arm, shoulder and hand) and radiographic outcomes of two methods of definitive internal fixation in active patients in boxer's fractures, operated in the first week.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2019
Typical duration 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
First Submitted
Initial submission to the registry
April 30, 2018
CompletedFirst Posted
Study publicly available on registry
July 31, 2018
CompletedStudy Start
First participant enrolled
February 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 5, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 10, 2020
CompletedJuly 30, 2019
July 1, 2019
4 months
April 30, 2018
July 29, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
patient outcome reported
QuickDASH
6 months
Study Arms (2)
control group
PLACEBO COMPARATORbouquet technique
test group
ACTIVE COMPARATORheadless screw
Interventions
Eligibility Criteria
You may qualify if:
- presence of an acute (0 to 7 days), closed and simple fracture of the metacarpal neck, absence of an ipsilateral injury or deformity, presence of an angulation of over 40 degrees in oblique plane imaging, being 18 years of age or older, having acquired a master's degree or still being a student, and being an employee in a social-professional environment with mild physical activities.
You may not qualify if:
- elderly, children, mental ness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Marcio Aurelio Aita
São Bernardo do Campo, São Paulo, 09732480, Brazil
Study Officials
- PRINCIPAL INVESTIGATOR
Marcio Aurelio a Aita
Centro Universitário FMABC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Affiliated Professor
Study Record Dates
First Submitted
April 30, 2018
First Posted
July 31, 2018
Study Start
February 1, 2019
Primary Completion
June 5, 2019
Study Completion
December 10, 2020
Last Updated
July 30, 2019
Record last verified: 2019-07