A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation in Distal Femur Fractures
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|ClinicalTrials.gov Identifier: NCT00429663|
Recruitment Status : Completed
First Posted : February 1, 2007
Results First Posted : February 9, 2017
Last Update Posted : May 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Femoral Fractures||Device: reamed, interlocking intramedullary nail Device: locking periarticular plate||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of Locked Plates Versus Intramedullary Nails in Distal Femur Fractures: A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation (S.O.L.V.E.D)|
|Study Start Date :||February 2007|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2016|
Reamed, Interlocking Intramedullary Nail - Randomized treatment
Device: reamed, interlocking intramedullary nail
Standard of care device for femur fracture repair
Locking Periarticular Plate - Randomized Treatment
Device: locking periarticular plate
Standard of care device for femur fractures
- EQ-5D [ Time Frame: 3 months, 6 months, 12 months ]EQ-5D (EuroQol) Health Index taken at 3 months, 6 months, 12 months follow up. The EQ-5D measures the subjects health status in 5 categories (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and totals them into 1 score. Scoring ranges from 0-100, 100 being best.
- Short Musculoskeletal Functional Assessment (SMFA) Score [ Time Frame: 3 months, 6 months, 12 months ]The Short Musculoskeletal Functional Assessment (SMFA) score. The questionnaire consists of four categories: Daily Activities, Emotional Status, Arm and Hand Function, Mobility. All categories are scored together, totaling between 0-100. The lower the score, the better the subjects function.
- EQ Index [ Time Frame: 3 months, 6 months, 12 months ]EQ Index is a visual analog scale that the subject uses to rank overall health and wellness on a scale of 0.00-1.00, 1.00 being best.
- SMFA - Bother Index [ Time Frame: 3 months, 6 months, 12 months ]The Bother Index is part of the SMFA. This section focuses on how much the injury is bothering the subject in terms of daily activities and use of injured area. The index totals are between 0-100. The lower the score, the less bothered the subject is by their injury.
- Valgus of Over 5 Degrees [ Time Frame: 12 months ]Valgus is a deformity involving oblique displacement of part of a limb away from the midline.
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): NCT00429663
Show 22 Study Locations
|Principal Investigator:||Paul Tornetta, M.D.||Boston University|