Suprapatellar Nailing of Tibial Shaft Fractures

Suprapatellar Nailing of Tibial Shaft Fractures: Long Term Follow Up

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02728362

Enrollment

Registered

2016-04-05

Start date

2016-04-30

Completion date

2019-01-31

Last updated

2023-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Broken Leg

Keywords

tibial shaft fractures

Brief summary

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

Detailed description

Suprapatellar nailing... Participants will be followed for 10 years prospectively. Follow up visits will occur at 2 weeks, 6weeks, 3 months, 6 months, 12 months, 3 years, 5 years, 7 years and 10 years. Interim analysis will be done at 1, 3, 5, and 7 years with final analysis occuring at 10 years. Primary and secondary endpoints in patients undergoing suprapatellar nailing of tibial shaft fractures are: 1. To evaluate the long term presence of knee pain 2. To evaluate the long term functional outcomes

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Long term presence of knee pain	10 years	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.

Secondary

Measure	Time frame	Description
Long term functional outcomes	10 years	During follow up visits participants will be administered the Lysholm knee score and the PROMIS Mobility measure. These forms will be analyzed together to determine the overall long term function of the participants.
Knee Range of Motion (ROM)	10 years	During follow up visits the participants knee ROM will be measured
Fracture Healing	10 years	During follow up visits fracture healing will be evaluated

Outcome results