Clinical Trial: A Comparison of Steel and Bioabsorbable Screw Fixation of Lisfranc Foot Injuries
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized, Prospective Comparison of Stainless Steel and Bioabsorbable Screw Fixation of Lisfranc Foot Injuries
Brief Summary: 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.
Detailed 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.
When the Lisfranc ligaments are disrupted, the 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 Lisfranc ligament injuries is surgery. 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. A second surgical procedure is often recommended to remove the screw 6 months after surgery. This allows for a complete return of normal foot range of motion, but at the cost of a second procedure.
The use of materials that can be absorbed by the human body to fix the Lisfranc ligaments has only been studied in 1 paper. One such material is the Smart Screw (Bionx, Blue Bell, Pennsylvania) which is approved by the Food and Drug Administration (F.D.A.) and made of polylevolactic acid (PLA). Absorbable screws could be ideal for the treatment of Lisfranc ligament injuries.
Comparing the long-term results of fixing the Lisfranc ligaments with either a steel or absorbable screw is important as there are no studies on the subject to date. There is only 1 published study regarding absorbable screws to fix the Lisfranc ligaments. The purpose of this study is to compare the outcome of steel and
Sponsor: Rothman Institute Orthopaedics
Current Primary Outcome: Foot and Ankle Ability Measures [ Time Frame: 3 years ]
Original Primary Outcome: Functional AOFAS Midfoot Score [ Time Frame: 3 years ]
Current Secondary Outcome:
- Visual Analog Score for pain [ Time Frame: 3 years ]
- X-rays for maintained healing [ Time Frame: 3 years ]
Original Secondary Outcome: Same as current
Information By: Rothman Institute Orthopaedics
Dates:
Date Received: May 31, 2008
Date Started: July 2008
Date Completion:
Last Updated: January 13, 2017
Last Verified: January 2017
