Status:
COMPLETED
Reconstruction Plate Compared With Flexible Intramedullary Nailing for Midshaft Clavicular Fractures
Lead Sponsor:
University of Sao Paulo
Conditions:
Clavicle Fracture
Eligibility:
All Genders
16-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to compare the clinical and radiographic results of patients with midshaft clavicular fractures treated with plates or intramedullary flexible nails fixation.
Detailed Description
Midshaft clavicular fractures are classically treated with non-surgical methods, supported by many authors as an effective treatment. However, different researches have shown high rates of nonunion an...
Eligibility Criteria
Inclusion
- Displaced Fractures of the middle third of the clavicle (no contact between the main fragments)
- Age between 16 and 65 year old;
- Terms of consent signed by the patient or guardian.
Exclusion
- Fracture of medial or lateral third of the clavicle;
- Cortical contact between the main fracture fragments;
- Age below 16 years old or more than 65 years old;
- Pathological fracture;
- Ipsilateral previous injuries of the shoulder or upper limb;
- Ipsilateral associated fractures of the shoulder or upper limb;
- Neuro-vascular injury associated;
- Open fracture not eligible for primary internal fixation;
- Clinical contraindication for surgery;
- Fracture older than 30 days;
- Patient not cooperative or ineligible for the follow-up;
- Lack of consent to participate.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT01410032
Start Date
July 1 2010
End Date
April 1 2014
Last Update
April 28 2014
Active Locations (1)
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1
University of Sao Paulo - Department of Orthopedics and Traumatology
São Paulo, São Paulo, Brazil, 05403-010