Boxer's FractureNCT03607045
Headless Screws x Bouquet in Boxer's Fracture
A study testing headless screw in people with Boxer's Fracture, run by Faculdade de Medicina do ABC at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Boxer's Fracture
- What is being tested?
- headless screw
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2019to 10 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- elderly, children, mental ness
Trial locations and contacts
1 site in 1 country.
Marcio Aurelio A Aita contact
Brazil1 site, 1 recruiting
- Recruiting
Marcio Aurelio Aita
São Bernardo do Campo, São Paulo, 09732480
Marcio Aurelio Aita, +5511999410400, marcioaita@me.com
Marcio Aurelio Aita
About this study
Official title: Headless Screws Versus Bouquet in Intramedullar Fixation of Boxer's Fracture: A Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Boxer's Fracture
- Being tested
- headless screw
- Keywords
- Boxer's Fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
headless screwDevice
headless screw group
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | bouquet technique Receives: Device: headless screw |
| test group | Active comparator | headless screw Receives: Device: headless screw |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient outcome reported
QuickDASH
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start1 Feb 2019
- Primary completion5 Jun 2019
- Study completion10 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Boxer's FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two groups homogeneous
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Faculdade de Medicina do ABC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcio Aurelio Aita, Faculdade de Medicina do ABC
- Investigators
- Marcio Aurelio a Aita, Principal investigator, Centro Universitário FMABC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03607045
- Sponsor's protocol ID
- 311718
- Status last verified
- Jul 2019
- First submitted
- 30 Apr 2018
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Headless Screws Versus Bouquet in Intramedullar Fixation of Boxer's Fracture: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03607045
- Acronym / sponsor ID
- 311718
- Conditions
- Boxer's Fracture
- Keywords
- Boxer's Fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Faculdade de Medicina do ABCUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 5 Jun 2019 (actual)
- Study completion
- 10 Dec 2020 (estimated)
- First posted
- 31 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- two groups homogeneous
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Device: headless screwbouquet technique |
| test group | Active comparator | Device: headless screwheadless screw |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- elderly, children, mental ness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| headless screwheadless screw group | Device | control group, test group |
Primary outcome
patient outcome reported
Time frame: 6 months
QuickDASH
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Boxer's Fracture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcio Aurelio A Aita contact
Marcio Aurelio a Aita principal investigator
Centro Universitário FMABC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing headless screw in people with Boxer's Fracture, run by Faculdade de Medicina do ABC at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcio Aurelio A Aita (+5511999410400, marcioaita@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient outcome reported (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2019.