CompletedNCT03434587Updated Feb 27, 2019

Syndactyly Versus Closed Reduction in 5th Metacarpal Neck Fracture

An interventional study of Syndactyly and Reduction and inmobilization in Metacarpal Fracture, sponsored by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-27.

Sponsored by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 72
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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.

Conditions studied

Metacarpal Fracture

Browse trials for

Fractures, Bone 2,262

Keywords

fifth metacarpal neck, fracture, syndactyly, inmobilization, RCT

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 72 participants (actual)

Study arms

Experimental
Syndactyly
Syndactyly
Procedure: Syndactyly
Active comparator
Reduction and inmobilization
Closed reduction and splint inmobilization
Procedure: Reduction and inmobilization

Interventions

ProcedureSyndactyly
Syndactyly
ProcedureReduction and inmobilization
Closed reduction and inmobilization with splint

What researchers measure

Primary outcomes

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
Time frame: 9 weeks

Secondary outcomes

Disabilities of the Arm, Shoulder and Hand (DASH) score
Comparison of DASH score at 3,6 weeks, 3 months and 1 year of emergency care in both treatment groups.
Time frame: 3 weeks, 1 year
Time to go back to job and sports
Comparison of the time to incorporation into the work and sports activity between both groups.
Time frame: 1 year
Angulation,
Comparison of angulation between both groups
Time frame: 3 weeks, 9 weeks
Range of mobility
Comparison of range of mobility between both groups
Time frame: 3 weeks, 9 weeks
Grip strength
Comparison of grip strength between both groups
Time frame: 3 weeks, 9 weeks
Visual Analogic Scale (VAS) for Pain score
Comparison of VAS score
Time frame: 3 weeks, 9 weeks, 1 year
Complication rate
Frequency of complications
Time frame: 1 year
Patient satisfaction (Modified Cooney Scale)
Satisfaction with the assigned treatment and its result between groups, measured by the modified cooney scale that ranges from 0 to 100
Time frame: 1 year

Study locations

1 site

Fundacion Jimenez Diaz
Madrid, 28040, Spain

Registry details

Key details

Study ID: NCT03434587
Lead sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Responsible party: Sponsor
First posted: Feb 15, 2018
Start date: Aug 2016
Primary completion: Jan 31, 2019
Completion: Jan 31, 2019
Last update: Feb 27, 2019

Study contacts

Samuel Pajares, MD

principal investigator · IIS-FJD

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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