Tibial Shaft Nailing Treated With Suprapatellar Nailing

Completed

• Conditions: Broken Leg
• Interventions: Other: Observation

• Registration Number: NCT02510339
• Lead Sponsor: Orlando Health, Inc.

Brief Summary

The goal of this project is to determine the incidence of intra-articular knee pathology following tibial shaft fractures as evaluated by intraoperative knee aspiration and physical exam, and to evaluate for chondral injuries following treatment with a suprapatellar tibial nail via MRI.

Detailed Description

Suprapatellar tibial nailing is gaining popularity throughout the orthopedic community for tibial shaft fractures, however the secondary effects of this technique on the articular cartilage of the knee is unknown. Additionally, the incidence of intra-articular knee pathology in the face of tibial shaft fractures has not been described in the orthopedic literature. An undiagnosed cruciate/collateral ligament injury can result in post-traumatic arthritis, as well as a delay in justified ligamentous reconstruction of the knee, causing further injury. Long term sequelae of now commonplace suprapatellar nailing on the patellofemoral joint of the knee have been sparsely elucidated in the literature.

The primary objective is to determine the consequences of suprapatellar tibial nailing on cartilage of the patellofemoral joint.

As a secondary objective, this study will seek to determine the incidence of intra-articular knee pathology following tibial shaft fractures in patients presenting to Orlando Regional Medical Center.

Study Timeline

• Study First Submitted: 2015-07-08
• Study First Submitted QC: 2015-07-27
• Study First Posted: 2015-07-29
• Status Verified: 2015-10
• Study Start: 2016-01-10
• Primary Completion: 2017-03-01
• Study Completion: 2017-03-01
• Last Update Submitted: 2017-04-07
• Last Update Posted: 2017-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

1. skeletally mature
2. open or closed fractures of the tibial shaft

Exclusion Criteria

1. concomitant tibial plateau or tibial pilon injuries
2. a knee dislocation
3. skeletally immature
4. those who will undergo standard (infra-patellar) tibial nailing

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational	Observation	The Lysholm Knee score and the SF-36 questionnairs will be given to patients presenting to Orlando Regional Medical Center with open or closed fractures of the tibial shaft during their follow up visits post operativily.

Primary Outcome Measures

Name	Time	Method
Consequences of suprapatellar tibial nailing	One year	During follow up visits, subjects will be given the Olerud-Molander questionnaire to complete. The data from that form will be analyzed for each visit.

Secondary Outcome Measures

Name	Time	Method
Incidences of intra-articular knee pathology	One year.	Post-operative radiographs will be analyzed during each visit per standard of care.
Functional assessment	One year	The functional assessment/progress of the patient will be noted at each follow up visit.