A Comparison of Steel and Bioabsorbable Screw Fixation of Lisfranc Foot Injuries (Lisfranc)
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|ClinicalTrials.gov Identifier: NCT00689962|
Recruitment Status : Completed
First Posted : June 4, 2008
Last Update Posted : January 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Joint Instability||Device: Linvatec 4.5 mm Smart Screw Device: Synthes 4.0 mm steel screw||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Prospective Comparison of Stainless Steel and Bioabsorbable Screw Fixation of Lisfranc Foot Injuries|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||July 2016|
Patients with unstable Lisfranc foot fracture-dislocations that receive bioabsorbable screw fixation through surgery.
Device: Linvatec 4.5 mm Smart Screw
Linvatec 4.5 mm Smart Screw to surgically fix the foot's Lisfranc ligaments
Active Comparator: 2
Patients with unstable Lisfranc fracture-dislocations of the foot that receive steel screw fixation through surgery.
Device: Synthes 4.0 mm steel screw
Standard steel screw use to surgically fix the foot's Lisfranc ligaments.
- Foot and Ankle Ability Measures [ Time Frame: 3 years ]
- Visual Analog Score for pain [ Time Frame: 3 years ]
- X-rays for maintained healing [ Time Frame: 3 years ]
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): NCT00689962
|United States, Pennsylvania|
|Riddle Memorial Hospital|
|Media, Pennsylvania, United States, 19063|
|Philadelphia, Pennsylvania, United States, 19152|
|Principal Investigator:||Jamal Ahmad, M.D.||Rothman Institute Orthopaedics|