Headless Screws x Bouquet in Boxer's Fracture
Primary Purpose
Boxer's Fracture
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
headless screw
Sponsored by
About this trial
This is an interventional treatment trial for Boxer's Fracture focused on measuring Boxer's Fracture
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- elderly, children, mental ness
Sites / Locations
- Marcio Aurelio AitaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
control group
test group
Arm Description
bouquet technique
headless screw
Outcomes
Primary Outcome Measures
patient outcome reported
QuickDASH
Secondary Outcome Measures
Full Information
NCT ID
NCT03607045
First Posted
April 30, 2018
Last Updated
July 29, 2019
Sponsor
Faculdade de Medicina do ABC
1. Study Identification
Unique Protocol Identification Number
NCT03607045
Brief Title
Headless Screws x Bouquet in Boxer's Fracture
Official Title
Headless Screws Versus Bouquet in Intramedullar Fixation of Boxer's Fracture: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
June 5, 2019 (Actual)
Study Completion Date
December 10, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Faculdade de Medicina do ABC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
A double center, parallel group, prospective, randomized clinical trial was conducted at the department of Hand Surgery, ABC University hospital, Santo Andre, Brazil and Hospital Mãe de Deus, Porto Alegre, Brazil. Two implants used for fixation in closed reduction of boxer's fractures were compared: the headless cannulated screws (Synthes®, Davos) and the Bouquet technique with k-wires (Synthes®, Davos). The protocol was approved by the local research ethics committee. All patients received, signed and are aware of what was recommended in the Informed Consent (IC). Inclusion criteria were; presence of an acute (0 to 7 days), closed and simple fracture of the metacarpal neck, absence of an ipsilateral injury or deformity, Start January 2017.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Boxer's Fracture
Keywords
Boxer's Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
two groups homogeneous
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
bouquet technique
Arm Title
test group
Arm Type
Active Comparator
Arm Description
headless screw
Intervention Type
Device
Intervention Name(s)
headless screw
Intervention Description
headless screw group
Primary Outcome Measure Information:
Title
patient outcome reported
Description
QuickDASH
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
elderly, children, mental ness
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marcio Aurelio A Aita
Phone
+5511999410400
Email
marcioaita@me.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marcio Aurelio A Aita
Email
marcioaita@me.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcio Aurelio a Aita
Organizational Affiliation
FMABC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marcio Aurelio Aita
City
São Bernardo Do Campo
State/Province
Sao Paulo
ZIP/Postal Code
09732480
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcio Aurelio Aita
Phone
+5511999410400
Email
marcioaita@me.com
First Name & Middle Initial & Last Name & Degree
Marcio Aurelio Aita
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Headless Screws x Bouquet in Boxer's Fracture
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