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Completed

NCT Number: NCT02510339

Tibial Shaft Nailing Treated With Suprapatellar Nailing

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.

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Key information

Conditions

Broken Leg

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • skeletally mature
  • open or closed fractures of the tibial shaft

Exclusion criteria

  • concomitant tibial plateau or tibial pilon injuries
  • a knee dislocation
  • skeletally immature
  • those who will undergo standard (infra-patellar) tibial nailing

Treatment and study plan

observation

Other

Administration of two questionnairs during post operative visits.

Primary outcomes

  1. Consequences of suprapatellar tibial nailing

    Time frame: 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 outcomes

  1. Incidences of intra-articular knee pathology

    Time frame: One year.

    Post-operative radiographs will be analyzed during each visit per standard of care.

  2. Functional assessment

    Time frame: One year

    The functional assessment/progress of the patient will be noted at each follow up visit.

Sponsors and collaborators

Lead sponsor

Orlando Health, Inc.

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 29, 2015
Registry last updated
Apr 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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