Tibial Shaft Nailing Treated With Suprapatellar Nailing

NCT ID: NCT02510339

Last Updated: 2017-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-10

Study Completion Date

2017-03-01

Brief Summary

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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

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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.

Conditions

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Broken Leg

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational

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.

Observation

Intervention Type OTHER

Administration of two questionnairs during post operative visits.

Interventions

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Observation

Administration of two questionnairs during post operative visits.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Orlando Health, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Paula J. Harriott

Clinical Research Coordinator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tara Roberts, BS

Role: STUDY_CHAIR

Orlando Health IRB corporate manager

Other Identifiers

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15.047.04

Identifier Type: -

Identifier Source: org_study_id

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