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Completed

NCT Number: NCT01879215

T1Rho MRI Evaluation of Patellofemoral Changes After Tibial IM Nailing

This study will utilize T1-Rho MRI to evaluate the effect of intramedullary nailing on patellofemoral articular cartilage when the surgery is performed using the infrapatellar vs. the suprapatellar approach. Subjects will be randomized to one or the other standard care surgical approaches.

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Key information

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Isolated tibial shaft fractures indicated for intramedullary nailing,
  • Acute tibia fractures,
  • Closed or open tibia fractures,
  • Skeletally mature patient between the ages of 21 and 50,
  • No prior history of knee surgery,
  • No prior history of knee pain,
  • No history of degenerative joint disease or inflammatory arthropathy
  • Not pregnant or known to be under the jurisdiction of the Department of Corrections
  • Able to provide informed consent.
  • Qualifies for standard care tibial IM nailing using either a suprapatellar or infrapatellar approach with no physician preference or definitive clinical indication for one or the other approach
  • Ability to communicate, read, and write in English
  • Intent of subject to receive follow up fracture care at the PI's institution.

Exclusion criteria

  • Tibial fractures requiring articular reconstruction (tibial plateau fractures and pilon fractures),
  • Periprosthetic fractures,
  • Nonunions or malunions,
  • History of previous knee surgery,
  • History of preexisting knee pain,
  • History of degenerative arthritis or inflammatory arthropathy, any evidence of degenerative changes of pre-operative knee radiographs, and any concomitant injury to that limb.
  • Any contraindication to MRI imaging
  • Retained stainless steel hardware proximal to the knee joint including, but not limited to prior knee replacement.
  • Under age 18 at the time of presentation, pregnant or planning to become pregnant within the study period, or under the jurisdiction of the Department of Corrections.
  • Inability to provide informed consent
  • Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
  • Insurance or other circumstantial restriction that would prohibit or interfere with the subject's ability to receive follow up care at the PI's institution.
  • Any condition, acute or chronic, that in the opinion of the attending physician or the Principal Investigator, would contraindicate participation in this study.

Treatment and study plan

Intramedullary nailing of the tibia

Procedure

Standard care surgery

Primary outcomes

  1. T1Rho MRI to quantify patellofemoral cartilage changes after IM nailing of the tibia as a primary treatment for acute tibial fractures.

    Time frame: Up to 6 months post-discharge

    The difference in proteoglycan content of patellofemoral articular cartilage as quantified using spin lattice relaxation in a rotating frame (T1ρ MRI weighted image) at 6 months post-hospital discharge between two groups randomized to undergo either a suprapatellar or infrapatellar approach to tibial IM nailing.

Secondary outcomes

  1. SF-36

    Time frame: Pre-op, 2 week scan, 6 months post discharge

    The difference in quality of life outcomes (Medical Outcomes Study: 36-Item Short Form Survey) at 6 months post-hospital discharge between two groups randomized to undergo either a suprapatellar or infrapatellar approach to tibial IM nailing.

  2. SMFA

    Time frame: Pre-op, 2 week scan, 6 months post discharge

    MFA46A Injury and Arthritis Survey

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Synthes USA HQ, Inc.

Registry information

Official study title

Patella Femoral Changes Following Tibial Nailing: Does Approach Matter?

Important dates

Study start
2013
Primary completion
2020
Study completion
2020
First posted
Jun 17, 2013
Registry last updated
Jul 22, 2020

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.