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T1Rho MRI Evaluation of Patellofemoral Changes After Tibial IM Nailing

Primary Purpose

Acute Tibial Fracture Requiring Intramedullary Nailing

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intramedullary nailing of the tibia
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Tibial Fracture Requiring Intramedullary Nailing

Eligibility Criteria

21 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital of the University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Suprapatellar Approach

Infrapatellar Approach

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

SF-36
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
MFA46A Injury and Arthritis Survey

Full Information

First Posted
June 12, 2013
Last Updated
July 21, 2020
Sponsor
University of Pennsylvania
Collaborators
Synthes USA HQ, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01879215
Brief Title
T1Rho MRI Evaluation of Patellofemoral Changes After Tibial IM Nailing
Official Title
Patella Femoral Changes Following Tibial Nailing: Does Approach Matter?
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
March 2020 (Actual)
Study Completion Date
July 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Synthes USA HQ, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Tibial Fracture Requiring Intramedullary Nailing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Suprapatellar Approach
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Infrapatellar Approach
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Intramedullary nailing of the tibia
Intervention Description
Standard care surgery
Primary Outcome Measure Information:
Title
T1Rho MRI to quantify patellofemoral cartilage changes after IM nailing of the tibia as a primary treatment for acute tibial fractures.
Description
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.
Time Frame
Up to 6 months post-discharge
Secondary Outcome Measure Information:
Title
SF-36
Description
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.
Time Frame
Pre-op, 2 week scan, 6 months post discharge
Title
SMFA
Description
MFA46A Injury and Arthritis Survey
Time Frame
Pre-op, 2 week scan, 6 months post discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samir Mehta, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Derek Donegan, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Annamarie Horan, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Study Director
Facility Information:
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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T1Rho MRI Evaluation of Patellofemoral Changes After Tibial IM Nailing

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