Metacarpal FractureBoxerfxNCT06449755
Elastic Nail Versus Screw for Intramedullary Fixation of Displaced Fractures of the Fifth Metacarpal Neck
A study testing Radiologic examination, Grip Strength and Quick DASH Questionnaire in people with Metacarpal Fracture and Boxer's Fracture, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to compare two different intramedullary fixation technique in patient diagnosed with deplased fifth metacarpal neck fracture. The main questions it aims to answer are: Can percutaneous screw application be a more stable fixation method than intramedullary elastic nail application?… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Metacarpal Fracture, Boxer's Fracture
- What is being tested?
- Radiologic examination, Grip Strength and Quick DASH Questionnaire
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 1 Feb 2025
- 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
- Patients aged 18-60 years with displaced fifth metacarpal fractures with angulation greater than 30 degrees
Who cannot join
- Open fracture
- Patients with multiple injuries
- History of hand surgery
- Intraarticular metacarpal neck fractures
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Unıversity Medicine Faculty Orthopaedic Department
Istanbul, Fatih, 34080
Ahmet Muçteba AM Yıldırım, Fellow, +090 534 303 8472, mucceba@gmail.com
About this study
Official title: Elastic Nail Versus Screw for Closed Reduction and Intramedullary Fixation of Displaced Fractures of the Fifth Metacarpal Neck: a Randomised Controlled Trial
The goal of this clinical trial is to compare two different intramedullary fixation technique in patient diagnosed with deplased fifth metacarpal neck fracture. The main questions it aims to answer are:
- Can percutaneous screw application be a more stable fixation method than intramedullary elastic nail application?
- Can screw application create a significant difference in the recovery of grip strength in the early period compared to elastic nail application? Patients will be followed up at the 1st week, 1st month and 3rd month postoperatively. Functionality will be evaluated with Quick DASH score at the 3rd month. At the 1st and 3rd month controls, grip strength will be evaluated. At the same time, metacarpal shortening and angulations will be measured on x-ray. Researchers will compare percutaneous screw and elastic nail group to see grip strength, healing time and radiologic parameter difference.
Read the detailed description
In this study, patients admitted to the emergency department with displaced fifth metacarpal neck fracture will be included. Exclusion criteria will include patients with other concomitant trauma, open fractures, fractures with intraarticular joint extension, and previous hand surgery in which the hand anatomy was distorted. Patients between the ages of 18 and 60 who have more than 30 degrees of angulation from the 30 degree hand pronation radiograph at admission and who consent to surgery will be included in the study. One of the two groups in the study will undergo closed reduction followed by percutaneous intramedullary retrograde screw fixation, while the other group will undergo intramedullary antegrade elastic nail application. Patients will be followed up with ulnar gutter splint for the first week postoperatively. After the first week, the splint will be removed and range of motion, gripping and pinching exercises will be given to the patients.
Radiological examinations (dorsal angulation and metacarpal shortening will be measured) will be performed in the first week, first and third months postoperatively. Hand grip strength will be measured with Cambry dynamometer at the first and third month. At the 3rd month, upper extremity functionality will be evaluated with Quick DASH score and a comparison will be made between the two groups.
Randomisation will be performed with an internet-based application. Clinical ethics committee approval was obtained before the study started.
- Conditions
- Metacarpal Fracture, Boxer's Fracture
- Being tested
- Radiologic examination, Grip Strength, Quick DASH Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiologic examinationDiagnostic test
Posoperative first week, month and third month On the x-ray of Hand AP view: metacarpal shortening On the x-ray of Hand 30 degree pronation view: dorsal angulation
Grip StrengthProcedure or surgery
Postoperative first month and third month grip streng compare with Cambry hand dinamometer.
Quick DASH QuestionnaireOther
Quick DASH is an 11-question questionnaire that assesses upper extremity functionality.
| Study group | Role | What they receive |
|---|---|---|
| Elastic Nail | Other | Percutaneous antegrade elastic nail fixation Receives: Diagnostic Test: Radiologic examination; Procedure: Grip Strength; Other: Quick DASH Questionnaire |
| Screw | Other | Percutaneous retrograde screw fixation Receives: Diagnostic Test: Radiologic examination; Procedure: Grip Strength; Other: Quick DASH Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dorsal Angulation and Metacarpal Shortening
Measurement of dorsal angulation between two fracture fragments on a hand oblique 30-degree pronation X-Ray Measurement of shortness of the fifth metacarpal on hand AP X-ray
Measured: Preoperative, Postoperative first week, first and third month
Secondary outcomes (1)
Grip Strength
Hand grip strength will be measured with CAMBRY hand dynamometer at 1 and 3 months postoperatively.
Measured: Postoperative first and third month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start1 Sep 2023
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metacarpal FractureStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AHMET MUCTEBA YILDIRIM, Istanbul University
- Investigators
- Serkan MD Bayram, MD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449755
- Sponsor's protocol ID
- 159108493
- Acronym
- Boxerfx
- Status last verified
- Jun 2024
- First submitted
- 4 Jun 2024
- Last updated
- 10 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elastic Nail Versus Screw for Closed Reduction and Intramedullary Fixation of Displaced Fractures of the Fifth Metacarpal Neck: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06449755
- Acronym / sponsor ID
- Boxerfx / 159108493
- Conditions
- Metacarpal Fracture, Boxer's Fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 10 Jun 2024 (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.
The goal of this clinical trial is to compare two different intramedullary fixation technique in patient diagnosed with deplased fifth metacarpal neck fracture. The main questions it aims to answer are:
- Can percutaneous screw application be a more stable fixation method than intramedullary elastic nail application?
- Can screw application create a significant difference in the recovery of grip strength in the early period compared to elastic nail application? Patients will be followed up at the 1st week, 1st month and 3rd month postoperatively. Functionality will be evaluated with Quick DASH score at the 3rd month. At the 1st and 3rd month controls, grip strength will be evaluated. At the same time, metacarpal shortening and angulations will be measured on x-ray. Researchers will compare percutaneous screw and elastic nail group to see grip strength, healing time and radiologic parameter difference.
Detailed description
In this study, patients admitted to the emergency department with displaced fifth metacarpal neck fracture will be included. Exclusion criteria will include patients with other concomitant trauma, open fractures, fractures with intraarticular joint extension, and previous hand surgery in which the hand anatomy was distorted. Patients between the ages of 18 and 60 who have more than 30 degrees of angulation from the 30 degree hand pronation radiograph at admission and who consent to surgery will be included in the study. One of the two groups in the study will undergo closed reduction followed by percutaneous intramedullary retrograde screw fixation, while the other group will undergo intramedullary antegrade elastic nail application. Patients will be followed up with ulnar gutter splint for the first week postoperatively. After the first week, the splint will be removed and range of motion, gripping and pinching exercises will be given to the patients.
Radiological examinations (dorsal angulation and metacarpal shortening will be measured) will be performed in the first week, first and third months postoperatively. Hand grip strength will be measured with Cambry dynamometer at the first and third month. At the 3rd month, upper extremity functionality will be evaluated with Quick DASH score and a comparison will be made between the two groups.
Randomisation will be performed with an internet-based application. Clinical ethics committee approval was obtained before the study started.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elastic Nail | Other | Diagnostic Test: Radiologic examination, Procedure: Grip Strength, Other: Quick DASH QuestionnairePercutaneous antegrade elastic nail fixation |
| Screw | Other | Diagnostic Test: Radiologic examination, Procedure: Grip Strength, Other: Quick DASH QuestionnairePercutaneous retrograde screw fixation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients aged 18-60 years with displaced fifth metacarpal fractures with angulation greater than 30 degrees
Key exclusion criteria (4 listed)
- Open fracture
- Patients with multiple injuries
- History of hand surgery
- Intraarticular metacarpal neck fractures
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 |
|---|---|---|
| Radiologic examinationPosoperative first week, month and third month On the x-ray of Hand AP view: metacarpal shortening On the x-ray of Hand 30 degree pronation view: dorsal angulation | Diagnostic test | Elastic Nail, Screw |
| Grip StrengthPostoperative first month and third month grip streng compare with Cambry hand dinamometer. | Procedure or surgery | Elastic Nail, Screw |
| Quick DASH QuestionnaireQuick DASH is an 11-question questionnaire that assesses upper extremity functionality. | Other | Elastic Nail, Screw |
Primary outcome
Dorsal Angulation and Metacarpal Shortening
Time frame: Preoperative, Postoperative first week, first and third month
Measurement of dorsal angulation between two fracture fragments on a hand oblique 30-degree pronation X-Ray Measurement of shortness of the fifth metacarpal on hand AP X-ray
1 secondary outcome
Grip Strength
Time frame: Postoperative first and third month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Serkan MD Bayram, MD principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiologic examination, Grip Strength and Quick DASH Questionnaire in people with Metacarpal Fracture and Boxer's Fracture, run by Istanbul University at 1 site in Turkey (Türkiye).
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 4 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 10 Jun 2024. 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 Turkey (Türkiye). 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. 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 Ahmet Muçteba AM Yıldırım, Fellow (+090 534 3038472, mucceba@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dorsal Angulation and Metacarpal Shortening (time frame: Preoperative, Postoperative first week, first and third month). 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 10 Jun 2024.