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NCT00985023 · ClinicalTrials.gov registry record · Phase 4
A Comparison of Stainless Steel and Bioabsorbable Screw Fixation of Lisfranc Foot Injuries
A Phase 4 study of Unstable Lisfranc Fracture-dislocations of the Midfoot, sponsored by Rothman Institute Orthopaedics.
- Completed
- Registry status
- Phase 4
- Development phase
- 50
- Enrollment target
- 2
- Study locations
NCT00985023 is a Phase 4 study of Unstable Lisfranc Fracture-dislocations of the Midfoot that has completed, run by Rothman Institute Orthopaedics. The registered enrollment target is 50 participants. The trial reports 2 study locations across 1 state.
The verdict
NCT00985023, a Phase 4 study of Unstable Lisfranc Fracture-dislocations of the Midfoot, has completed, sponsored by Rothman Institute Orthopaedics.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 50 participants
- Enrollment target
- 2
- Study locations
Study Summary
The Lisfranc ligaments are a group of ligaments that connect the bones of the middle portion of the foot to each other. The Lisfranc ligaments allow for a normal and stable range of motion and shape to the foot. In certain foot fractures where the Lisfranc ligaments are damaged, the constraint and stability it had given to the middle of the foot is lost. Attempted activity at the foot will result in pain and abnormal motion. If injury to the Lisfranc ligaments is left untreated, the eventual end result is foot arthritis and deformity. The current standard orthopaedic treatment of foot fractures with Lisfranc ligament injuries is surgery. The foot fractures are fixed with metal screws. The Lisfranc ligaments are fixed by compressing the space between the middle bones of the foot with steel screws. These screws allow for ligament healing. As the ligaments heal, the patient should not resume activity with the fixed foot too soon as the screw may break. Upon breakage, the ligament repair may fail and the screw is now difficult to surgically remove. Regardless of breakage, a second surgical procedure is often recommended to remove the steel screw 6 months after foot surgery. This allows for a complete return of normal foot range of motion, but at the cost of a second surgical procedure. The investigators hypothesize that absorbable screw fixation of the 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.
Conditions Studied
Interventions
- PROCEDURE Steel screw fixation of Lisfranc fracture-dislocation.
- PROCEDURE Absorbable screw fixation of Lisfranc fracture-dislocations.
Study Locations (2)
Pennsylvania
- Riddle Memorial Hospital - Media
- Nazareth Hospital - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2008-08 |
| Est. Completion | 2016-08 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00985023
The ClinicalTrials.gov registry entry for NCT00985023 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rothman Institute Orthopaedics, which has 23 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Unstable Lisfranc Fracture-dislocations of the Midfoot appearing as the primary indexed condition, and to 2 interventions - of which Steel screw fixation of Lisfranc fracture-dislocation. is the first listed.
NCT00985023 reports 2 study locations spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00985023 about?
NCT00985023 is a clinical study titled "A Comparison of Stainless Steel and Bioabsorbable Screw Fixation of Lisfranc Foot Injuries". The Lisfranc ligaments are a group of ligaments that connect the bones of the middle portion of the foot to each other. The Lisfranc ligaments allow for a normal and stable range of motion and shape to the foot. In certain foot fractures where the Lisfranc ligaments are damaged, the constraint and s...
What is the current status of trial NCT00985023?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2008-08. Estimated completion is 2016-08.
What conditions does trial NCT00985023 study?
This clinical trial studies the following conditions: Unstable Lisfranc Fracture-dislocations of the Midfoot.
What interventions are being tested in trial NCT00985023?
The interventions under investigation include: Steel screw fixation of Lisfranc fracture-dislocation. (PROCEDURE), Absorbable screw fixation of Lisfranc fracture-dislocations. (PROCEDURE).
Who is sponsoring clinical trial NCT00985023?
This trial is sponsored by Rothman Institute Orthopaedics, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00985023 being conducted?
This trial has 2 study locations across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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