NCT02728362

Brief Summary

To investigate the functional outcomes and prevalence and severity of knee pain for patients undergoing suprapatellar nailing of tibial shaft fractures.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2016

Typical duration for all trials

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

First Submitted

Initial submission to the registry

March 24, 2016

Completed
8 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 5, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

October 18, 2023

Status Verified

October 1, 2023

Enrollment Period

2.8 years

First QC Date

March 24, 2016

Last Update Submit

October 17, 2023

Conditions

Broken Leg

Keywords

tibial shaft fractures

Outcome Measures

Primary Outcomes (1)

  • Long term presence of knee pain

    During follow up visits participants will be administered the Visual Analog Scale (VAS) and the Patient Reported Outcomes Measurement Information System (PROMIS) Pain intensity short form 3a and Pain interference short form 8a. These forms will be analyzed together to determine an overall presence of knee pain.

    10 years

Secondary Outcomes (3)

  • Long term functional outcomes

    10 years

  • Knee Range of Motion (ROM)

    10 years

  • Fracture Healing

    10 years

Eligibility Criteria

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

Patients presenting with tibial shaft fractures.

You may qualify if:

  • Isolated, unilateral tibial shaft fractures
  • Orthopaedic Trauma Association (OTA) classification of 42 and may extend to 43A or 43B
  • age 18-65, including pregnant women
  • open or closed fractures
  • able to sign consent
  • english speaking

You may not qualify if:

  • compartment syndrome
  • other lower extremity injuries that will affect functional outcomes
  • problems maintaining follow up (homeless, not willing to return for follow up)
  • pathological fractures
  • prisoners
  • previous retained hardware in the injured leg
  • injuries requiring vascular repair

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Blake W Miller, DO

    Corewell Health West

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2016

First Posted

April 5, 2016

Study Start

April 1, 2016

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

October 18, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share