Syndactyly Versus Closed Reduction in 5th Metacarpal Neck Fracture

Metacarpal Fracture Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03434587
• Other study ID #: FJD-5MTC-16/01
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: January 31, 2019

Study information

• Verified date: August 2017
• Source: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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.

Related Conditions & MeSH terms

• Fractures, Bone
• Metacarpal Fracture
• Syndactyly

Intervention

Procedure:
• Syndactyly
Syndactyly
• Reduction and inmobilization
Closed reduction and inmobilization with splint

Locations

Country	Name	City	State
Spain	Fundacion Jimenez Diaz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	9 weeks
Secondary	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.	3 weeks, 1 year
Secondary	Time to go back to job and sports	Comparison of the time to incorporation into the work and sports activity between both groups.	1 year
Secondary	Angulation,	Comparison of angulation between both groups	3 weeks, 9 weeks
Secondary	Range of mobility	Comparison of range of mobility between both groups	3 weeks, 9 weeks
Secondary	Grip strength	Comparison of grip strength between both groups	3 weeks, 9 weeks
Secondary	Visual Analogic Scale (VAS) for Pain score	Comparison of VAS score	3 weeks, 9 weeks, 1 year
Secondary	Complication rate	Frequency of complications	1 year
Secondary	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	1 year