Metacarpal FractureNCT03434587
Syndactyly Versus Closed Reduction in 5th Metacarpal Neck Fracture
A study testing Syndactyly and Reduction and inmobilization in people with Metacarpal Fracture, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
Trial summary
This study aims to compare the functional results of two different therapeutic approaches in patients that present with a 5th metacarpal neck fracture. Patients will be randomly assigned to be treated with either syndactyly or closed reduction plus inmovilization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metacarpal Fracture
- What is being tested?
- Syndactyly and Reduction and inmobilization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSpain
- Study dates
- Aug 2016to 31 Jan 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and Women ≥ 18 years old.
- Admitted to the Emergency Department with fracture of 5th metacarpal neck, in acute phase (maximum 72 h of evolution) with a possibility of clinical and radiological follow-up of at least 6 months.
- Willing to participate in the study and give their consent in writing.
Who cannot join
- Patients younger than 18 years.
- Patients presenting with more than 72 h of evolution
- Patients with comminuted neck fractures.
- Patients with angulation greater than 70 in the lateral-oblique plane
- Patients with clinical-radiological disruption
- Patients with previous fractures in the metacarpal.
Show all 15Show fewer
- Patients with open fracture grade II-III Gustilo.
- Patients with bifocal fractures or fractures in another metacarpal-phalanx or carpal bones requiring different treatment.
- Polytraumatized patients requiring further care that prevents them from adjusting to the therapeutic regimen specific to the protocol of isolated metacarpal fractures.
- Patients with congenital anomalies on hand affect
- Patients with a psychic disability (dementia-psychiatric illness or mental disorder) that prevents their collaboration in the follow-up
- Patients with medical or surgical pathologies that at the discretion of the investigator do not allow their participation in the study.
- Patients with inability to understand the nature and purpose of the study and / or to accept written participation in the study.
- Unable to attend the pre-established clinical follow-up.
- Do not wish to participate or give their consent in writing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label Trial to Compare the Functional and Radiological Results of Syndactyly Versus Closed Reduction and Immobilization in Patients With 5th Metacarpal Neck Fracture
This study aims to compare the functional results of two different therapeutic approaches in patients that present with a 5th metacarpal neck fracture. Patients will be randomly assigned to be treated with either syndactyly or closed reduction plus inmovilization.
Read the detailed description
Syndactyly, although limiting the activity of the patient, allows a quick mobilization and recovery, as well as a better management in daily activities compared with immobilization with splint. In addition, follow-up of these fractures is difficult due to poor compliance, since patient profile is young people who give little relevance to their pathology in the hand.
The purpose of our study is to carry out a randomized clinical trial of good methodological quality to assess whether immobilization with syndactyly for 3 weeks does not imply loss of functionality or residual symptoms, avoiding rigidity, postinflammation arthritis or loss of grip strength, demonstrating that early mobilization of fractures of the fifth metacarpal provides clinically satisfactory results compared to prolonged immobilization provided that the volar fracture angle does not exceed 70 ° nor does it produce digital movement disruption.
- Conditions
- Metacarpal Fracture
- Being tested
- Syndactyly, Reduction and inmobilization
- Keywords
- fifth metacarpal neck, fracture, syndactyly, inmobilization, RCT
- Medical subject headings
- Fractures, Bone, Syndactyly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SyndactylyProcedure or surgery
Syndactyly
Reduction and inmobilizationProcedure or surgery
Closed reduction and inmobilization with splint
| Study group | Role | What they receive |
|---|---|---|
| Syndactyly | Experimental | Syndactyly Receives: Procedure: Syndactyly |
| Reduction and inmobilization | Active comparator | Closed reduction and splint inmobilization Receives: Procedure: Reduction and inmobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disabilities of the Arm, Shoulder and Hand (DASH) score
Comparison of DASH score at 9 weeks of emergency care in both treatment groups. Score range is from 0 to 100
Measured: 9 weeks
Secondary outcomes (8)
Disabilities of the Arm, Shoulder and Hand (DASH) score
Comparison of DASH score at 3,6 weeks, 3 months and 1 year of emergency care in both treatment groups.
Measured: 3 weeks, 1 year
Time to go back to job and sports
Comparison of the time to incorporation into the work and sports activity between both groups.
Measured: 1 year
Angulation,
Comparison of angulation between both groups
Measured: 3 weeks, 9 weeks
Range of mobility
Comparison of range of mobility between both groups
Measured: 3 weeks, 9 weeks
Grip strength
Comparison of grip strength between both groups
Measured: 3 weeks, 9 weeks
Visual Analogic Scale (VAS) for Pain score
Comparison of VAS score
Measured: 3 weeks, 9 weeks, 1 year
Complication rate
Frequency of complications
Measured: 1 year
Patient satisfaction (Modified Cooney Scale)
Satisfaction with the assigned treatment and its result between groups, measured by the modified cooney scale that ranges from 0 to 100
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study startAug 2016
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
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.
- 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
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samuel Pajares, MD, Principal investigator, IIS-FJD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03434587
- Sponsor's protocol ID
- FJD-5MTC-16/01
- Status last verified
- Aug 2017
- First submitted
- 26 Jan 2018
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label Trial to Compare the Functional and Radiological Results of Syndactyly Versus Closed Reduction and Immobilization in Patients With 5th Metacarpal Neck Fracture
- ClinicalTrials.gov ID
- NCT03434587
- Acronym / sponsor ID
- FJD-5MTC-16/01
- Conditions
- Metacarpal Fracture
- Keywords
- fifth metacarpal neck, fracture, syndactyly, inmobilization, RCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 15 Feb 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.
This study aims to compare the functional results of two different therapeutic approaches in patients that present with a 5th metacarpal neck fracture. Patients will be randomly assigned to be treated with either syndactyly or closed reduction plus inmovilization.
Detailed description
Syndactyly, although limiting the activity of the patient, allows a quick mobilization and recovery, as well as a better management in daily activities compared with immobilization with splint. In addition, follow-up of these fractures is difficult due to poor compliance, since patient profile is young people who give little relevance to their pathology in the hand.
The purpose of our study is to carry out a randomized clinical trial of good methodological quality to assess whether immobilization with syndactyly for 3 weeks does not imply loss of functionality or residual symptoms, avoiding rigidity, postinflammation arthritis or loss of grip strength, demonstrating that early mobilization of fractures of the fifth metacarpal provides clinically satisfactory results compared to prolonged immobilization provided that the volar fracture angle does not exceed 70 ° nor does it produce digital movement disruption.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Syndactyly | Experimental | Procedure: SyndactylySyndactyly |
| Reduction and inmobilization | Active comparator | Procedure: Reduction and inmobilizationClosed reduction and splint inmobilization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and Women ≥ 18 years old.
- Admitted to the Emergency Department with fracture of 5th metacarpal neck, in acute phase (maximum 72 h of evolution) with a possibility of clinical and radiological follow-up of at least 6 months.
- Willing to participate in the study and give their consent in writing.
Key exclusion criteria (15 listed)
- Patients younger than 18 years.
- Patients presenting with more than 72 h of evolution
- Patients with comminuted neck fractures.
- Patients with angulation greater than 70 in the lateral-oblique plane
- Patients with clinical-radiological disruption
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 |
|---|---|---|
| SyndactylySyndactyly | Procedure or surgery | Syndactyly |
| Reduction and inmobilizationClosed reduction and inmobilization with splint | Procedure or surgery | Reduction and inmobilization |
Primary outcome
Disabilities of the Arm, Shoulder and Hand (DASH) score
Time frame: 9 weeks
Comparison of DASH score at 9 weeks of emergency care in both treatment groups. Score range is from 0 to 100
8 secondary outcomes
Disabilities of the Arm, Shoulder and Hand (DASH) score
Time frame: 3 weeks, 1 year
Time to go back to job and sports
Time frame: 1 year
Angulation,
Time frame: 3 weeks, 9 weeks
Range of mobility
Time frame: 3 weeks, 9 weeks
Grip strength
Time frame: 3 weeks, 9 weeks
Visual Analogic Scale (VAS) for Pain score
Time frame: 3 weeks, 9 weeks, 1 year
Complication rate
Time frame: 1 year
Patient satisfaction (Modified Cooney Scale)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
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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.
Samuel Pajares, MD principal investigator
IIS-FJD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Syndactyly and Reduction and inmobilization in people with Metacarpal Fracture, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
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 3 inclusion and 15 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: finished, as of the sponsor's last update on 27 Feb 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disabilities of the Arm, Shoulder and Hand (DASH) score (time frame: 9 weeks). 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 27 Feb 2019.