Clinical trial NCT03434587: Syndactyly Versus Closed Reduction in 5th Metacarpal Neck Fracture
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metacarpal Fracture
Keywords: fifth metacarpal neck, fracture, syndactyly, inmobilization, RCT
Lead sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Sponsor class: OTHER
First posted: 2018-02-15
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Disabilities of the Arm, Shoulder and Hand (DASH) score
timeFrame: 9 weeks
Secondary outcomes:
measure: Disabilities of the Arm, Shoulder and Hand (DASH) score
timeFrame: 3 weeks, 1 year
measure: Time to go back to job and sports
timeFrame: 1 year
measure: Angulation,
timeFrame: 3 weeks, 9 weeks
measure: Range of mobility
timeFrame: 3 weeks, 9 weeks
measure: Grip strength
timeFrame: 3 weeks, 9 weeks
measure: Visual Analogic Scale (VAS) for Pain score
timeFrame: 3 weeks, 9 weeks, 1 year
measure: Complication rate
timeFrame: 1 year
measure: Patient satisfaction (Modified Cooney Scale)
timeFrame: 1 year
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz
Study officials:
affiliation: IIS-FJD
name: Samuel Pajares, MD
role: PRINCIPAL_INVESTIGATOR
References: