T1Rho MRI Evaluation of Patellofemoral Changes After Tibial IM Nailing

NCT01879215 | Completed DMC

• 1 other identifier: 817841
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Tibial Fracture Requiring Intramedullary Nailing

Outcome Measures

Primary Outcomes (1)

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

  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.

  Up to 6 months post-discharge

Secondary Outcomes (2)

• SF-36

  Pre-op, 2 week scan, 6 months post discharge

• SMFA

  Pre-op, 2 week scan, 6 months post discharge

Study Arms (2)

Suprapatellar Approach

ACTIVE COMPARATOR

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

Infrapatellar Approach

ACTIVE COMPARATOR

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

Interventions

Intramedullary nailing of the tibia PROCEDURE

Standard care surgery

Infrapatellar Approach; Suprapatellar Approach

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• Synthes USA HQ, Inc.: collaborator

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Study Officials

• Samir Mehta, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Derek Donegan, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Annamarie Horan, PhD

  University of Pennsylvania

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2013
• First Posted: June 17, 2013
• Study Start: June 1, 2013
• Primary Completion: March 1, 2020
• Study Completion: July 1, 2020
• Last Updated: July 22, 2020

Record last verified: 2020-07

Locations

US (1)