Reconstruction Plate Compared With Flexible Intramedullary Nailing for Midshaft Clavicular Fractures
1 other identifier
interventional
59
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2010
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 23, 2011
CompletedFirst Posted
Study publicly available on registry
August 4, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedApril 28, 2014
April 1, 2014
3.5 years
May 23, 2011
April 25, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
DASH score
Disabilities of the Arm, Shoulder and Hand score (0: best function; 100: worst function)
6 months
Secondary Outcomes (6)
DASH score
12 months
Constant-Murley Score
6 and 12 months PO
Time to Union
Monthly
Radiographic residual shortening
6 months
Patient satisfaction with the treatment
6 and 12 months
- +1 more secondary outcomes
Study Arms (2)
Plate fixation
ACTIVE COMPARATORReconstruction plate
ESIN
ACTIVE COMPARATORESIN (Elastic Stable Intramedullary Nailing)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Sao Paulo - Department of Orthopedics and Traumatology
São Paulo, São Paulo, 05403-010, Brazil
Related Publications (1)
Andrade-Silva FB, Kojima KE, Joeris A, Santos Silva J, Mattar R Jr. Single, superiorly placed reconstruction plate compared with flexible intramedullary nailing for midshaft clavicular fractures: a prospective, randomized controlled trial. J Bone Joint Surg Am. 2015 Apr 15;97(8):620-6. doi: 10.2106/JBJS.N.00497.
PMID: 25878305DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fernando B Andrade-Silva, MD
University of Sao Paulo - Department of Orthopedics and Traumatology
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
May 23, 2011
First Posted
August 4, 2011
Study Start
July 1, 2010
Primary Completion
January 1, 2014
Study Completion
April 1, 2014
Last Updated
April 28, 2014
Record last verified: 2014-04