Syndactyly Versus Closed Reduction in 5th Metacarpal Neck Fracture

NCT ID: NCT03434587

Last Updated: 2019-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2019-01-31

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.

Conditions

Metacarpal Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Syndactyly

Syndactyly

Group Type: EXPERIMENTAL

Syndactyly

Intervention Type: PROCEDURE

Syndactyly

Reduction and inmobilization

Closed reduction and splint inmobilization

Group Type: ACTIVE_COMPARATOR

Reduction and inmobilization

Intervention Type: PROCEDURE

Closed reduction and inmobilization with splint

Interventions

Syndactyly

Syndactyly

Intervention Type: PROCEDURE

Reduction and inmobilization

Closed reduction and inmobilization with splint

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samuel Pajares, MD

Role: PRINCIPAL_INVESTIGATOR

IIS-FJD

Locations

Fundacion Jimenez Diaz

Madrid, , Spain

Countries

Spain

Other Identifiers

FJD-5MTC-16/01

Identifier Type: -

Identifier Source: org_study_id