NCT00689962

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2008

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 4, 2008

Completed
27 days until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

January 18, 2017

Status Verified

January 1, 2017

Enrollment Period

8 years

First QC Date

May 31, 2008

Last Update Submit

January 13, 2017

Conditions

Joint Instability

Keywords

Lisfrancfracturedislocationbioabsorbable

Outcome Measures

Primary Outcomes (1)

  • Foot and Ankle Ability Measures

    3 years

Secondary Outcomes (2)

  • Visual Analog Score for pain

    3 years

  • X-rays for maintained healing

    3 years

Study Arms (2)

1

EXPERIMENTAL

Patients with unstable Lisfranc foot fracture-dislocations that receive bioabsorbable screw fixation through surgery.

Device: Linvatec 4.5 mm Smart Screw

2

ACTIVE COMPARATOR

Patients with unstable Lisfranc fracture-dislocations of the foot that receive steel screw fixation through surgery.

Device: Synthes 4.0 mm steel screw

Interventions

Linvatec 4.5 mm Smart ScrewDEVICE

Linvatec 4.5 mm Smart Screw to surgically fix the foot's Lisfranc ligaments

1
Synthes 4.0 mm steel screwDEVICE

Standard steel screw use to surgically fix the foot's Lisfranc ligaments.

2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Riddle Memorial Hospital

Media, Pennsylvania, 19063, United States

Location

Nazareth Hospital

Philadelphia, Pennsylvania, 19152, United States

Location

Related Publications (1)

  • Thordarson DB, Hurvitz G. PLA screw fixation of Lisfranc injuries. Foot Ankle Int. 2002 Nov;23(11):1003-7. doi: 10.1177/107110070202301106.

    PMID: 12449404BACKGROUND

MeSH Terms

Conditions

Joint InstabilityFractures, BoneJoint Dislocations

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesWounds and Injuries

Study Officials

  • Jamal Ahmad, M.D.

    Rothman Institute Orthopaedics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Orthopaedic Surgery

Study Record Dates

First Submitted

May 31, 2008

First Posted

June 4, 2008

Study Start

July 1, 2008

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

January 18, 2017

Record last verified: 2017-01

Locations

US(2)