NCT02534259

Brief Summary

The objective of this study is to develop methods for using forces measured on circular external fixators to predict the state of individual patient's healing of severe tibial fractures and defects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

August 21, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 27, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2018

Completed
Last Updated

February 18, 2019

Status Verified

February 1, 2019

Enrollment Period

2.6 years

First QC Date

August 21, 2015

Last Update Submit

February 14, 2019

Conditions

Tibial Fractures

Outcome Measures

Primary Outcomes (1)

  • Forces measured in the external fixator during ambulation during clinical visits

    Approximately 5 times across treatment, with treatment lasting months to a year or more

Secondary Outcomes (1)

  • Forces measured in instrumented insoles during ambulation during clinical visits

    Approximately 5 times across treatment, with treatment lasting months to a year or more

Other Outcomes (1)

  • Radiographic and other clinical assessment of bone healing during clinical visits

    Approximately 5 times across treatment, with treatment lasting months to a year or more

Interventions

Force monitoring of external fixator strutsOTHER

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing treatment for severe tibia fracture and/or defect using a circular external fixator.

You may qualify if:

  • to 80 years of age
  • Patients scheduled to undergo or currently undergoing treatment at Hershey Medical Center for tibia fracture and/or defect using a circular external fixator including Ilizarov and Taylor Spatial Frame types.
  • Ability to perform study procedures including ambulation (with assistance device if needed)

You may not qualify if:

  • External fixator design that cannot be suitably instrumented for force measurements due to space constraints or other issues
  • Axially stable fracture
  • Inability to understand English
  • Inability to provide informed consent
  • Difficulty maintaining follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Tibial Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Study Officials

  • Gregory Lewis, PhD

    Milton S. Hershey Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 21, 2015

First Posted

August 27, 2015

Study Start

August 1, 2015

Primary Completion

March 14, 2018

Study Completion

March 14, 2018

Last Updated

February 18, 2019

Record last verified: 2019-02

Locations

US(1)