Suprapatellar Nailing of Tibial Shaft Fractures
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|ClinicalTrials.gov Identifier: NCT02728362|
Recruitment Status : Enrolling by invitation
First Posted : April 5, 2016
Last Update Posted : January 11, 2018
|Condition or disease|
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:
- To evaluate the long term presence of knee pain
- To evaluate the long term functional outcomes
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Suprapatellar Nailing of Tibial Shaft Fractures: Long Term Follow Up|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||April 2028|
|Estimated Study Completion Date :||April 2028|
- Long term presence of knee pain [ Time Frame: 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.
- Long term functional outcomes [ Time Frame: 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) [ Time Frame: 10 years ]During follow up visits the participants knee ROM will be measured
- Fracture Healing [ Time Frame: 10 years ]During follow up visits fracture healing will be evaluated
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02728362
|Principal Investigator:||Blake W Miller, DO||Spectrum Health Hospitals|