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Syndactyly Versus Closed Reduction in 5th Metacarpal Neck Fracture

I

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Status

Completed

Conditions

Metacarpal Fracture

Treatments

Procedure: Reduction and inmobilization
Procedure: Syndactyly

Study type

Interventional

Funder types

Other

Identifiers

NCT03434587
FJD-5MTC-16/01

Details and patient eligibility

About

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.

Full 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.

Enrollment

72 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

72 participants in 2 patient groups

Syndactyly
Experimental group
Description:
Syndactyly
Treatment:
Procedure: Syndactyly
Reduction and inmobilization
Active Comparator group
Description:
Closed reduction and splint inmobilization
Treatment:
Procedure: Reduction and inmobilization

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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