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| Sponsor: | Rothman Institute Orthopaedics |
|---|---|
| Information provided by: | Rothman Institute Orthopaedics |
| ClinicalTrials.gov Identifier: | NCT00689962 |
Purpose
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 |
|---|---|---|
|
Joint Instability |
Device: Linvatec 4.5 mm Smart Screw Device: Synthes 4.0 mm steel screw |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
|---|---|
|
Experimental: 1
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
Other Name: Linvatec 4.5 mm Smart Screw
|
|
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.
Other Name: Synthes 4.0 mm steel screw
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Jamal Ahmad, M.D. | 215-992-4996 | jamal.ahmad@rothmaninstitute.com |
| United States, Pennsylvania | |
| Riddle Memorial Hospital | Not yet recruiting |
| Media, Pennsylvania, United States, 19063 | |
| Contact: Jamal Ahmad, M.D. 215-992-4996 jamal.ahmad@rothmaninstitute.com | |
| Principal Investigator: Jamal Ahmad, M.D. | |
| Nazareth Hospital | Not yet recruiting |
| Philadelphia, Pennsylvania, United States, 19152 | |
| Contact: Jamal Ahmad, M.D. 215-992-4996 jamal.ahmad@rothmaninstitute.com | |
| Principal Investigator: Jamal Ahmad, M.D. | |
| Thomas Jefferson University Hospital | Recruiting |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Contact: Steven M Raikin, M.D. 267-339-3500 steven.raikin@rothmaninstitute.com | |
| Contact: Jamal Ahmad, M.D. 215-992-4996 jamal.ahmad@rothmaninstitute.com | |
| Principal Investigator: Steven M Raikin, M.D. | |
| Principal Investigator: | Jamal Ahmad, M.D. | Rothman Institute Orthopaedics |
More Information
| Responsible Party: | Jamal Ahmad/Principal Investigator/Assistant Professor of Orthopaedic Surgery, Rothman Institute Orthopaedics |
| ClinicalTrials.gov Identifier: | NCT00689962 History of Changes |
| Other Study ID Numbers: | Lisfranc 1 |
| Study First Received: | May 31, 2008 |
| Last Updated: | July 24, 2011 |
| Health Authority: | United States: Institutional Review Board |
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Lisfranc fracture dislocation bioabsorbable |
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Joint Instability Foot Injuries Joint Diseases |
Musculoskeletal Diseases Leg Injuries Wounds and Injuries |