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

This study is not yet open for participant recruitment.

Verified by Rothman Institute Orthopaedics, May 2008

First Received: May 31, 2008 Last Updated: June 3, 2008 History of Changes

Sponsored by:	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:	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

Resource links provided by NLM:

MedlinePlus related topics: Foot Health Foot Injuries and Disorders

U.S. FDA Resources

Further study details as provided by Rothman Institute Orthopaedics:

Primary Outcome Measures:

Functional AOFAS Midfoot Score [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Visual Analog Score for pain [ Time Frame: 3 years ] [ Designated as safety issue: No ]
X-rays for maintained healing [ Time Frame: 3 years ] [ Designated as safety issue: No ]

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
1: Experimental Bioabsorbable screw fixation for Lisfranc ligaments in the foot.	Device: Linvatec 4.5 mm Smart Screw Linvatec 4.5 mm Smart Screw to surgically fix the foot's Lisfranc ligaments
2: Active Comparator Steel screw fixation for Lisfranc ligaments in the foot.	Device: Synthes 4.0 mm steel screw Standard steel screw use to surgically fix the foot's Lisfranc ligaments.

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Subjects will be adults of any gender or race.
Subjects will be adults between 18 and 75 years of age.
The underlying diagnosis will be a Lisfranc foot injury.
The indication for fixing the Lisfranc ligaments is abnormal separation of the middle part of the foot from each other.
Subjects will have received either a steel or absorbable screw to fix the Lisfranc ligaments.

Exclusion Criteria:

Subjects may not have any cognitive impairment that would, in the investigator's opinion, preclude study participation or compliance with protocol mandated procedures.
Subjects may not have a history of known alcohol, analgesic, or narcotic substance abuse within 12 months prior to pretreatment.
Subjects may not have a history of severe psychiatric illness such as depression or psychosis that may influence the results of administered outcome questionnaires.
Subjects may not be pregnant.
Subjects may be excluded from this study for any reason that may pose unnecessary risk or confounding of data, in the judgment of the investigator.

This includes the 4 above points.
Subjects must not have intact or normal Lisfranc ligaments in the foot.
Subjects may not have a history of deep Lisfranc joint infection.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00689962

Contacts

Contact: Jamal Ahmad, M.D.

215-992-4996

jamal.ahmad@rothmaninstitute.com

Locations

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

Sponsors and Collaborators

Rothman Institute Orthopaedics

Investigators

Principal Investigator:

Jamal Ahmad, M.D.

Rothman Institute Orthopaedics

More Information

Publications:

Thordarson DB, Hurvitz G. PLA screw fixation of Lisfranc injuries. Foot Ankle Int. 2002 Nov;23(11):1003-7.

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 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Rothman Institute Orthopaedics:

Lisfranc
fracture
dislocation
bioabsorbable

Study placed in the following topic categories:

Musculoskeletal Diseases
Dislocations
Joint Diseases
Foot Injuries
Fractures, Bone

Wounds and Injuries
Disorders of Environmental Origin
Leg Injuries
Joint Instability

Additional relevant MeSH terms:

Musculoskeletal Diseases
Joint Diseases
Foot Injuries
Wounds and Injuries

Disorders of Environmental Origin
Leg Injuries
Joint Instability

ClinicalTrials.gov processed this record on July 06, 2009