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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Metacarpal Fracture
- Sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Disabilities of the Arm, Shoulder and Hand (DASH) score
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
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
- Grip strength(3 weeks, 9 weeks)
- Patient satisfaction (Modified Cooney Scale)(1 year)
- Disabilities of the Arm, Shoulder and Hand (DASH) score(3 weeks, 1 year)
- Range of mobility(3 weeks, 9 weeks)
- Visual Analogic Scale (VAS) for Pain score(3 weeks, 9 weeks, 1 year)
- Time to go back to job and sports(1 year)
- Angulation,(3 weeks, 9 weeks)
- Complication rate(1 year)