Suprapatellar Nailing of Tibial Shaft Fractures

Completed

• Conditions: Broken Leg

• Registration Number: NCT02728362
• Lead Sponsor: Spectrum Health Hospitals

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

Study Timeline

• Study First Submitted: 2016-03-24
• Study First Submitted QC: 2016-03-30
• Study Start: 2016-04
• Study First Posted: 2016-04-05
• Primary Completion: 2019-01
• Study Completion: 2019-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-17
• Last Update Posted: 2023-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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.