Tibial Shaft Nailing Treated With Suprapatellar Nailing

Broken Leg Clinical Trial

Official title:

The Incidence of Associated Intra-articular Knee Pathology With Concomitant Tibial Shaft Fractures Treated With Suprapatellar Nailing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02510339
• Other study ID #: 15.047.04
• Status: Completed
• Phase: N/A
• First received: July 8, 2015
• Last updated: April 7, 2017
• Start date: January 10, 2016
• Est. completion date: March 1, 2017

Study information

• Verified date: October 2015
• Source: Orlando Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 1, 2017
• Est. primary completion date: March 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Broken Leg

Intervention

Other:
• Observation
Administration of two questionnairs during post operative visits.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Orlando Health, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Consequences of suprapatellar tibial nailing	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.	One year
Secondary	Incidences of intra-articular knee pathology	Post-operative radiographs will be analyzed during each visit per standard of care.	One year.
Secondary	Functional assessment	The functional assessment/progress of the patient will be noted at each follow up visit.	One year