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T1Rho MRI Evaluation of Patellofemoral Changes After Tibial IM Nailing

This study is currently recruiting participants.
Verified November 2017 by University of Pennsylvania
Sponsor:
ClinicalTrials.gov Identifier:
NCT01879215
First Posted: June 17, 2013
Last Update Posted: November 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Synthes USA HQ, Inc.
Information provided by (Responsible Party):
University of Pennsylvania
  Purpose
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.

Condition Intervention
Acute Tibial Fracture Requiring Intramedullary Nailing Procedure: Intramedullary nailing of the tibia

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Patella Femoral Changes Following Tibial Nailing: Does Approach Matter?

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • SMFA [ Time Frame: Pre-op, 2 week scan, 6 months post discharge ]
    MFA46A Injury and Arthritis Survey


Estimated Enrollment: 60
Study Start Date: June 2013
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Suprapatellar Approach
Suprapatellar Approach to Intramedullary Nailing. Surgeons will be allowed to use any size intramedullary tibial nail through an suprapatellar incision and splitting the quadriceps tendon.
Procedure: Intramedullary nailing of the tibia
Standard care surgery
Active Comparator: Infrapatellar Approach
Infrapatellar Approach Intramedullary Nailing. Surgeons will be allowed to use any size intramedullary tibial nail through an infrapatellar incision using either a medial parapatellar approach or a transpatellar approach. The knee will then be scanned using T1Rho MRI at 2 weeks postoperatively and 6 months postoperatively.
Procedure: Intramedullary nailing of the tibia
Standard care surgery

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Isolated tibial shaft fractures indicated for intramedullary nailing,
  2. Acute tibia fractures,
  3. Closed or open tibia fractures,
  4. Skeletally mature patient between the ages of 21 and 50,
  5. No prior history of knee surgery,
  6. No prior history of knee pain,
  7. No history of degenerative joint disease or inflammatory arthropathy
  8. Not pregnant or known to be under the jurisdiction of the Department of Corrections
  9. Able to provide informed consent.
  10. 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
  11. Ability to communicate, read, and write in English
  12. Intent of subject to receive follow up fracture care at the PI's institution.

Exclusion Criteria:

  1. Tibial fractures requiring articular reconstruction (tibial plateau fractures and pilon fractures),
  2. Periprosthetic fractures,
  3. Nonunions or malunions,
  4. History of previous knee surgery,
  5. History of preexisting knee pain,
  6. History of degenerative arthritis or inflammatory arthropathy, any evidence of degenerative changes of pre-operative knee radiographs, and any concomitant injury to that limb.
  7. Any contraindication to MRI imaging
  8. Retained stainless steel hardware proximal to the knee joint including, but not limited to prior knee replacement.
  9. 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.
  10. Inability to provide informed consent
  11. Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
  12. 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.
  13. Any condition, acute or chronic, that in the opinion of the attending physician or the Principal Investigator, would contraindicate participation in this study.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01879215


Contacts
Contact: Brandon Eilberg, BS 2152949167 brandon.eilberg@uphs.upenn.edu
Contact: Thomas Rose, BS 2152949113 thomas.rose@uphs.upenn.edu

Locations
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Brandon Eilberg, BS    215-294-9167    brandon.eilberg@uphs.upenn.edu   
Contact: Thomas Rose, BS    2152949113    Thomas.rose@upenn.uphs.edu   
Principal Investigator: Samir Mehta, MD         
Sub-Investigator: Derek Donegan, MD         
Sub-Investigator: Annamarie Horan, PhD         
Sub-Investigator: Jaimo Ahn, MD         
Sponsors and Collaborators
University of Pennsylvania
Synthes USA HQ, Inc.
Investigators
Principal Investigator: Samir Mehta, MD University of Pennsylvania
Principal Investigator: Derek Donegan, MD University of Pennsylvania
Study Director: Annamarie Horan, PhD University of Pennsylvania
  More Information

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01879215     History of Changes
Other Study ID Numbers: 817841
First Submitted: June 12, 2013
First Posted: June 17, 2013
Last Update Posted: November 9, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Tibial Fractures
Fractures, Bone
Wounds and Injuries
Leg Injuries