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

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.

Study Overview

• Status: Completed
• Conditions: Metacarpal Fracture
• Intervention / Treatment: Procedure: Syndactyly; Procedure: Reduction and inmobilization

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 Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Fundacion Jimenez Diaz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Syndactyly	Procedure: Syndactyly; Syndactyly
ACTIVE_COMPARATOR: Reduction and inmobilization; Closed reduction and splint inmobilization	Procedure: Reduction and inmobilization; Closed reduction and inmobilization with splint

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Angulation,	Comparison of angulation between both groups	3 weeks, 9 weeks
Range of mobility	Comparison of range of mobility between both groups	3 weeks, 9 weeks
Grip strength	Comparison of grip strength between both groups	3 weeks, 9 weeks
Visual Analogic Scale (VAS) for Pain score	Comparison of VAS score	3 weeks, 9 weeks, 1 year
Complication rate	Frequency of complications	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	1 year

Collaborators and Investigators

• Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
• Investigators: Principal Investigator: Samuel Pajares, MD, IIS-FJD

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2016
• Primary Completion (ACTUAL): January 31, 2019
• Study Completion (ACTUAL): January 31, 2019

Study Registration Dates

• First Submitted: January 26, 2018
• First Submitted That Met QC Criteria: February 8, 2018
• First Posted (ACTUAL): February 15, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 27, 2019
• Last Update Submitted That Met QC Criteria: February 26, 2019
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: fifth metacarpal neck, fracture, syndactyly, inmobilization, RCT
• Additional Relevant MeSH Terms: Wounds and Injuries; Congenital Abnormalities; Musculoskeletal Diseases; Bone Diseases; Musculoskeletal Abnormalities; Bone Diseases, Developmental; Limb Deformities, Congenital; Dysostoses; Synostosis; Fractures, Bone; Syndactyly
• Other Study ID Numbers: FJD-5MTC-16/01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No