T1Rho MRI Evaluation of Patellofemoral Changes After Tibial IM Nailing

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of Pennsylvania
Sponsor:
Collaborator:
Synthes USA HQ, Inc.
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01879215
First received: June 12, 2013
Last updated: April 15, 2014
Last verified: June 2013
  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: 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 ] [ Designated as safety issue: No ]
    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: 6 months post discharge ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20
Study Start Date: June 2013
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Suprapatellar Approach Procedure: Intramedullary nailing of the tibia
Standard care surgery
Active Comparator: Infrapatellar Approach Procedure: Intramedullary nailing of the tibia
Standard care surgery

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01879215

Contacts
Contact: Patrick Hesketh, BS 781-985-9556 patrick.hesketh@uphs.upenn.edu

Locations
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Patrick Hesketh, BS    781-985-9556    patrick.hesketh@uphs.upenn.edu   
Principal Investigator: Samir Mehta, MD         
Sponsors and Collaborators
University of Pennsylvania
Synthes USA HQ, Inc.
  More Information

No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01879215     History of Changes
Other Study ID Numbers: 817841
Study First Received: June 12, 2013
Last Updated: April 15, 2014
Health Authority: United States: Office of Human Research Protections

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

ClinicalTrials.gov processed this record on September 18, 2014