T1Rho MRI Evaluation of Patellofemoral Changes After Tibial IM Nailing

NCT ID: NCT01879215

Last Updated: 2020-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2020-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Intramedullary nailing of the tibia

Intervention Type: PROCEDURE

Standard care surgery

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.

Group Type: ACTIVE_COMPARATOR

Intramedullary nailing of the tibia

Intervention Type: PROCEDURE

Standard care surgery

Interventions

Intramedullary nailing of the tibia

Standard care surgery

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Synthes USA HQ, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samir Mehta, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Derek Donegan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Annamarie Horan, PhD

Role: STUDY_DIRECTOR

University of Pennsylvania

Locations

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

817841

Identifier Type: -

Identifier Source: org_study_id