Suprapatellar Nailing of Tibial Shaft Fractures

Broken Leg Clinical Trial

Official title:

Suprapatellar Nailing of Tibial Shaft Fractures: Long Term Follow Up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02728362
• Other study ID #: 2016-027
• Status: Completed
• Start date: April 2016
• Est. completion date: January 2019

Study information

• Verified date: October 2023
• Source: Spectrum Health Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Broken Leg
• Fractures, Bone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Spectrum Health Hospitals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Long term functional outcomes	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.	10 years
Secondary	Knee Range of Motion (ROM)	During follow up visits the participants knee ROM will be measured	10 years
Secondary	Fracture Healing	During follow up visits fracture healing will be evaluated	10 years