NCT03434587

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 15, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
Last Updated

February 27, 2019

Status Verified

August 1, 2017

Enrollment Period

2.5 years

First QC Date

January 26, 2018

Last Update Submit

February 26, 2019

Conditions

Metacarpal Fracture

Keywords

fifth metacarpal neck, fracture, syndactyly, inmobilization, RCT

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

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

    3 weeks, 1 year

  • Time to go back to job and sports

    1 year

  • Angulation,

    3 weeks, 9 weeks

  • Range of mobility

    3 weeks, 9 weeks

  • Grip strength

    3 weeks, 9 weeks

  • +3 more secondary outcomes

Study Arms (2)

Syndactyly

EXPERIMENTAL

Syndactyly

Procedure: Syndactyly

Reduction and inmobilization

ACTIVE COMPARATOR

Closed reduction and splint inmobilization

Procedure: Reduction and inmobilization

Interventions

SyndactylyPROCEDURE

Syndactyly

Syndactyly
Reduction and inmobilizationPROCEDURE

Closed reduction and inmobilization with splint

Reduction and inmobilization

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundacion Jimenez Diaz

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Fractures, BoneSyndactyly

Condition Hierarchy (Ancestors)

Wounds and InjuriesSynostosisDysostosesBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Samuel Pajares, MD

    IIS-FJD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2018

First Posted

February 15, 2018

Study Start

August 1, 2016

Primary Completion

January 31, 2019

Study Completion

January 31, 2019

Last Updated

February 27, 2019

Record last verified: 2017-08

Locations

ES(1)