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Completed

NCT Number: NCT03434587

Syndactyly Versus Closed Reduction in 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

Syndactyly

Procedure

Syndactyly

Reduction and inmobilization

Procedure

Closed reduction and inmobilization with splint

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Feb 15, 2018
Registry last updated
Feb 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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