Syndactyly Versus Closed Reduction in 5th Metacarpal Neck Fracture
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|ClinicalTrials.gov Identifier: NCT03434587|
Recruitment Status : Completed
First Posted : February 15, 2018
Last Update Posted : February 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Metacarpal Fracture||Procedure: Syndactyly Procedure: Reduction and inmobilization||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Active Comparator: Reduction and inmobilization
Closed reduction and splint inmobilization
Procedure: Reduction and inmobilization
Closed reduction and inmobilization with splint
- 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
- 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.
- 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.
- Angulation, [ Time Frame: 3 weeks, 9 weeks ]Comparison of angulation between both groups
- Range of mobility [ Time Frame: 3 weeks, 9 weeks ]Comparison of range of mobility between both groups
- Grip strength [ Time Frame: 3 weeks, 9 weeks ]Comparison of grip strength between both groups
- Visual Analogic Scale (VAS) for Pain score [ Time Frame: 3 weeks, 9 weeks, 1 year ]Comparison of VAS score
- Complication rate [ Time Frame: 1 year ]Frequency of complications
- 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
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
|Fundacion Jimenez Diaz|
|Madrid, Spain, 28040|
|Principal Investigator:||Samuel Pajares, MD||IIS-FJD|