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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

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.

Condition or disease Intervention/treatment Phase
Metacarpal Fracture Procedure: Syndactyly Procedure: Reduction and inmobilization Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 2016
Actual Primary Completion Date : January 31, 2019
Actual Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Experimental: Syndactyly
Syndactyly
Procedure: Syndactyly
Syndactyly

Active Comparator: Reduction and inmobilization
Closed reduction and splint inmobilization
Procedure: Reduction and inmobilization
Closed reduction and inmobilization with splint




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Angulation, [ Time Frame: 3 weeks, 9 weeks ]
    Comparison of angulation between both groups

  4. Range of mobility [ Time Frame: 3 weeks, 9 weeks ]
    Comparison of range of mobility between both groups

  5. Grip strength [ Time Frame: 3 weeks, 9 weeks ]
    Comparison of grip strength between both groups

  6. Visual Analogic Scale (VAS) for Pain score [ Time Frame: 3 weeks, 9 weeks, 1 year ]
    Comparison of VAS score

  7. Complication rate [ Time Frame: 1 year ]
    Frequency of complications

  8. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03434587


Locations
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Spain
Fundacion Jimenez Diaz
Madrid, Spain, 28040
Sponsors and Collaborators
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Investigators
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Principal Investigator: Samuel Pajares, MD IIS-FJD
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Responsible Party: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
ClinicalTrials.gov Identifier: NCT03434587    
Other Study ID Numbers: FJD-5MTC-16/01
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz:
fifth metacarpal neck, fracture, syndactyly, inmobilization, RCT
Additional relevant MeSH terms:
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Syndactyly
Fractures, Bone
Wounds and Injuries
Synostosis
Dysostoses
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Congenital Abnormalities