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Syndactyly Versus Closed Reduction in 5th Metacarpal Neck Fracture

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03434587
Enrollment
72
Registered
2018-02-15
Start date
2016-08-31
Completion date
2019-01-31
Last updated
2019-02-27

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

Conditions

Metacarpal Fracture

Keywords

fifth metacarpal neck, fracture, syndactyly, inmobilization, RCT

Brief 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.

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.

Interventions

PROCEDURESyndactyly

Syndactyly

PROCEDUREReduction and inmobilization

Closed reduction and inmobilization with splint

Sponsors

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

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

Inclusion criteria

* Inclusion Criteria: * 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. *

Exclusion criteria

* 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. * 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.

Design outcomes

Primary

MeasureTime frameDescription
Disabilities of the Arm, Shoulder and Hand (DASH) score9 weeksComparison of DASH score at 9 weeks of emergency care in both treatment groups. Score range is from 0 to 100

Secondary

MeasureTime frameDescription
Time to go back to job and sports1 yearComparison of the time to incorporation into the work and sports activity between both groups.
Angulation,3 weeks, 9 weeksComparison of angulation between both groups
Range of mobility3 weeks, 9 weeksComparison of range of mobility between both groups
Disabilities of the Arm, Shoulder and Hand (DASH) score3 weeks, 1 yearComparison of DASH score at 3,6 weeks, 3 months and 1 year of emergency care in both treatment groups.
Visual Analogic Scale (VAS) for Pain score3 weeks, 9 weeks, 1 yearComparison of VAS score
Complication rate1 yearFrequency of complications
Patient satisfaction (Modified Cooney Scale)1 yearSatisfaction with the assigned treatment and its result between groups, measured by the modified cooney scale that ranges from 0 to 100
Grip strength3 weeks, 9 weeksComparison of grip strength between both groups

Countries

Spain

Outcome results

None listed

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