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A Comparison of Stainless Steel and Bioabsorbable Screw Fixation of Lisfranc Foot Injuries

NCT00985023 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-01-18

No results posted yet for this 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

  • Unstable Lisfranc Fracture-dislocations of the Midfoot

Interventions

PROCEDURE

Steel screw fixation of Lisfranc fracture-dislocation.

Stainless steel screw fixation of unstable Lisfranc fracture-dislocations of the midfoot.

PROCEDURE

Absorbable screw fixation of Lisfranc fracture-dislocations.

Bioabsorbable (poly-levo-lactic acid) screw fixation of unstable Lisfranc fracture-dislocations of the midfoot.

Sponsors & Collaborators

  • Rothman Institute Orthopaedics

    lead OTHER

Principal Investigators

  • Jamal Ahmad, M.D. · Rothman Institute Orthopaedics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00985023 on ClinicalTrials.gov