NCT02510339

Brief Summary

The goal of this project is to determine the incidence of intra-articular knee pathology following tibial shaft fractures as evaluated by intraoperative knee aspiration and physical exam, and to evaluate for chondral injuries following treatment with a suprapatellar tibial nail via MRI.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2016

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

July 8, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 29, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

January 10, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

April 10, 2017

Status Verified

October 1, 2015

Enrollment Period

1.1 years

First QC Date

July 8, 2015

Last Update Submit

April 7, 2017

Conditions

Broken Leg

Outcome Measures

Primary Outcomes (1)

  • Consequences of suprapatellar tibial nailing

    During follow up visits, subjects will be given the Olerud-Molander questionnaire to complete. The data from that form will be analyzed for each visit.

    One year

Secondary Outcomes (2)

  • Incidences of intra-articular knee pathology

    One year.

  • Functional assessment

    One year

Study Arms (1)

Observational

The Lysholm Knee score and the SF-36 questionnairs will be given to patients presenting to Orlando Regional Medical Center with open or closed fractures of the tibial shaft during their follow up visits post operativily.

Other: Observation

Interventions

ObservationOTHER

Administration of two questionnairs during post operative visits.

Observational

Eligibility Criteria

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

The study population will include skeletally mature patients of Level One Orthopaedics, presenting to Orlando Regional Medical Center with open or closed fractures of the tibial shaft.

You may qualify if:

  • skeletally mature
  • open or closed fractures of the tibial shaft

You may not qualify if:

  • concomitant tibial plateau or tibial pilon injuries
  • a knee dislocation
  • skeletally immature
  • those who will undergo standard (infra-patellar) tibial nailing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Tara Roberts, BS

    Orlando Health IRB corporate manager

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Research Coordinator

Study Record Dates

First Submitted

July 8, 2015

First Posted

July 29, 2015

Study Start

January 10, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

April 10, 2017

Record last verified: 2015-10