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Syndactyly Versus Closed Reduction in 5th Metacarpal Neck Fracture

Primary Purpose

Metacarpal Fracture

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Syndactyly

Reduction and inmobilization

About this trial

This is an interventional treatment trial for Metacarpal Fracture focused on measuring fifth metacarpal neck, fracture, syndactyly, inmobilization, RCT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Fundacion Jimenez Diaz

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Syndactyly

Reduction and inmobilization

Arm Description

Syndactyly

Closed reduction and splint inmobilization

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Time to go back to job and sports

Comparison of the time to incorporation into the work and sports activity between both groups.

Angulation,

Comparison of angulation between both groups

Range of mobility

Comparison of range of mobility between both groups

Grip strength

Comparison of grip strength between both groups

Visual Analogic Scale (VAS) for Pain score

Comparison of VAS score

Complication rate

Frequency of complications

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

Full Information

NCT ID

NCT03434587

First Posted

January 26, 2018

Last Updated

February 26, 2019

Sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

1. Study Identification

Unique Protocol Identification Number

NCT03434587

Brief Title

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

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

August 2016 (Actual)

Primary Completion Date

January 31, 2019 (Actual)

Study Completion Date

January 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metacarpal Fracture

Keywords

fifth metacarpal neck, fracture, syndactyly, inmobilization, RCT

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Syndactyly

Arm Type

Experimental

Arm Description

Syndactyly

Arm Title

Reduction and inmobilization

Arm Type

Active Comparator

Arm Description

Closed reduction and splint inmobilization

Intervention Type

Procedure

Intervention Name(s)

Syndactyly

Intervention Description

Syndactyly

Intervention Type

Procedure

Intervention Name(s)

Reduction and inmobilization

Intervention Description

Closed reduction and inmobilization with splint

Primary Outcome Measure Information:

Title

Disabilities of the Arm, Shoulder and Hand (DASH) score

Description

Comparison of DASH score at 9 weeks of emergency care in both treatment groups. Score range is from 0 to 100

Time Frame

9 weeks

Secondary Outcome Measure Information:

Title

Disabilities of the Arm, Shoulder and Hand (DASH) score

Description

Comparison of DASH score at 3,6 weeks, 3 months and 1 year of emergency care in both treatment groups.

Time Frame

3 weeks, 1 year

Title

Time to go back to job and sports

Description

Comparison of the time to incorporation into the work and sports activity between both groups.

Time Frame

1 year

Title

Angulation,

Description

Comparison of angulation between both groups

Time Frame

3 weeks, 9 weeks

Title

Range of mobility

Description

Comparison of range of mobility between both groups

Time Frame

3 weeks, 9 weeks

Title

Grip strength

Description

Comparison of grip strength between both groups

Time Frame

3 weeks, 9 weeks

Title

Visual Analogic Scale (VAS) for Pain score

Description

Comparison of VAS score

Time Frame

3 weeks, 9 weeks, 1 year

Title

Complication rate

Description

Frequency of complications

Time Frame

1 year

Title

Patient satisfaction (Modified Cooney Scale)

Description

Satisfaction with the assigned treatment and its result between groups, measured by the modified cooney scale that ranges from 0 to 100

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Samuel Pajares, MD

Organizational Affiliation

IIS-FJD

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fundacion Jimenez Diaz

City

Madrid

ZIP/Postal Code

28040

Country

Spain

12. IPD Sharing Statement

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Syndactyly Versus Closed Reduction in 5th Metacarpal Neck Fracture

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