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Headless Screws x Bouquet in Boxer's Fracture

Headless Screws Versus Bouquet in Intramedullar Fixation of Boxer's Fracture: A Randomized Clinical Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03607045
Enrollment
24
Registered
2018-07-31
Start date
2019-02-01
Completion date
2020-12-10
Last updated
2019-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Boxer's Fracture

Keywords

Boxer's Fracture

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.

Interventions

DEVICEheadless screw

headless screw group

Sponsors

Faculdade de Medicina do ABC
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Intervention model description

two groups homogeneous

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
patient outcome reported6 monthsQuickDASH

Countries

Brazil

Contacts

Primary ContactMarcio Aurelio A Aita
marcioaita@me.com+5511999410400
Backup ContactMarcio Aurelio A Aita
marcioaita@me.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026