Fundacion Jimenez Diaz
Madrid, 28040, Spain
NCT Number: NCT03434587
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Madrid, 28040, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Syndactyly
Closed reduction and inmobilization with splint
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
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 frame: 1 year
Comparison of the time to incorporation into the work and sports activity between both groups.
Time frame: 3 weeks, 9 weeks
Comparison of angulation between both groups
Time frame: 3 weeks, 9 weeks
Comparison of range of mobility between both groups
Time frame: 3 weeks, 9 weeks
Comparison of grip strength between both groups
Time frame: 3 weeks, 9 weeks, 1 year
Comparison of VAS score
Time frame: 1 year
Frequency of complications
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
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Other
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
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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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