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Syndactyly Versus Closed Reduction in 5th Metacarpal Neck Fracture

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03434587
Recruitment Status : Completed
First Posted : February 15, 2018
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Tracking Information
First Submitted Date  ICMJE January 26, 2018
First Posted Date  ICMJE February 15, 2018
Last Update Posted Date February 27, 2019
Actual Study Start Date  ICMJE August 2016
Actual Primary Completion Date January 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2018)
Disabilities of the Arm, Shoulder and Hand (DASH) score [ Time Frame: 9 weeks ]
Comparison of DASH score at 9 weeks of emergency care in both treatment groups. Score range is from 0 to 100
Original Primary Outcome Measures  ICMJE
 (submitted: February 8, 2018)
Disabilities of the Arm, Shoulder and Hand (DASH) score [ Time Frame: 6 months ]
Comparison of DASH score at 6 months of emergency care in both treatment groups. Score range is from 0 to 100
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2018)
  • Disabilities of the Arm, Shoulder and Hand (DASH) score [ Time Frame: 3 weeks, 1 year ]
    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 [ Time Frame: 1 year ]
    Comparison of the time to incorporation into the work and sports activity between both groups.
  • Angulation, [ Time Frame: 3 weeks, 9 weeks ]
    Comparison of angulation between both groups
  • Range of mobility [ Time Frame: 3 weeks, 9 weeks ]
    Comparison of range of mobility between both groups
  • Grip strength [ Time Frame: 3 weeks, 9 weeks ]
    Comparison of grip strength between both groups
  • Visual Analogic Scale (VAS) for Pain score [ Time Frame: 3 weeks, 9 weeks, 1 year ]
    Comparison of VAS score
  • Complication rate [ Time Frame: 1 year ]
    Frequency of complications
  • Patient satisfaction (Modified Cooney Scale) [ Time Frame: 1 year ]
    Satisfaction with the assigned treatment and its result between groups, measured by the modified cooney scale that ranges from 0 to 100
Original Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2018)
  • Disabilities of the Arm, Shoulder and Hand (DASH) score [ Time Frame: 3 weeks, 6 weeks , 3 months, 1 year ]
    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 [ Time Frame: 1 year ]
    Comparison of the time to incorporation into the work and sports activity between both groups.
  • Angulation, [ Time Frame: 3 weeks, 6 weeks , 3 months, 6 months ]
    Comparison of angulation between both groups
  • Range of mobility [ Time Frame: 3 weeks, 6 weeks , 3 months, 6 months ]
    Comparison of range of mobility between both groups
  • Grip strength [ Time Frame: 3 weeks, 6 weeks , 3 months, 6 months ]
    Comparison of grip strength between both groups
  • Visual Analogic Scale (VAS) for Pain score [ Time Frame: 3 weeks, 6 weeks , 3 months, 6 months, 1 year ]
    Comparison of VAS score
  • Complication rate [ Time Frame: 1 year ]
    Frequency of complications
  • Patient satisfaction (Modified Cooney Scale) [ Time Frame: 1 year ]
    Satisfaction with the assigned treatment and its result between groups, measured by the modified cooney scale that ranges from 0 to 100
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Syndactyly Versus Closed Reduction in 5th Metacarpal Neck Fracture
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metacarpal Fracture
Intervention  ICMJE
  • Procedure: Syndactyly
    Syndactyly
  • Procedure: Reduction and inmobilization
    Closed reduction and inmobilization with splint
Study Arms  ICMJE
  • Experimental: Syndactyly
    Syndactyly
    Intervention: Procedure: Syndactyly
  • Active Comparator: Reduction and inmobilization
    Closed reduction and splint inmobilization
    Intervention: Procedure: Reduction and inmobilization
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 8, 2018)
72
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 31, 2019
Actual Primary Completion Date January 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03434587
Other Study ID Numbers  ICMJE FJD-5MTC-16/01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Study Sponsor  ICMJE Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Samuel Pajares, MD IIS-FJD
PRS Account Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP