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Sponsored by: |
Rothman Institute Orthopaedics |
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Information provided by: | Rothman Institute Orthopaedics |
ClinicalTrials.gov Identifier: | NCT00689962 |
I hypothesize that absorbable screw fixation of the foot's Lisfranc ligaments does not yield significant differences in postoperative foot stability, ligament function, and symptoms when compared to steel screw fixation. In addition, absorbable screw fixation of the Lisfranc ligaments offers the advantage that a second surgical procedure to remove the screw is not necessary.
Condition | Intervention | Phase |
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Joint Instability |
Device: Linvatec 4.5 mm Smart Screw Device: Synthes 4.0 mm steel screw |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment |
Official Title: | A Randomized, Prospective Comparison of Stainless Steel and Bioabsorbable Screw Fixation of Lisfranc Foot Injuries |
Estimated Enrollment: | 60 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | July 2011 |
Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Bioabsorbable screw fixation for Lisfranc ligaments in the foot.
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Device: Linvatec 4.5 mm Smart Screw
Linvatec 4.5 mm Smart Screw to surgically fix the foot's Lisfranc ligaments
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2: Active Comparator
Steel screw fixation for Lisfranc ligaments in the foot.
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Device: Synthes 4.0 mm steel screw
Standard steel screw use to surgically fix the foot's Lisfranc ligaments.
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jamal Ahmad, M.D. | 215-992-4996 | jamal.ahmad@rothmaninstitute.com |
United States, Pennsylvania | |
Nazareth Hospital | |
Philadelphia, Pennsylvania, United States, 19152 | |
Thomas Jefferson University Hospital | |
Philadelphia, Pennsylvania, United States, 19107 | |
Riddle Memorial Hospital | |
Media, Pennsylvania, United States, 19063 |
Principal Investigator: | Jamal Ahmad, M.D. | Rothman Institute Orthopaedics |
Responsible Party: | Rothman Institute Orthopaedics ( Jamal Ahmad/Principal Investigator/Assistant Professor of Orthopaedic Surgery ) |
Study ID Numbers: | Lisfranc 1 |
Study First Received: | May 31, 2008 |
Last Updated: | June 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00689962 |
Health Authority: | United States: Institutional Review Board |
Lisfranc fracture dislocation bioabsorbable |
Musculoskeletal Diseases Dislocations Joint Diseases Foot Injuries Fractures, Bone |
Wounds and Injuries Disorders of Environmental Origin Leg Injuries Joint Instability |