Acute Tibial Fracture Requiring Intramedullary Nailing Clinical Trial
Official title:
Patella Femoral Changes Following Tibial Nailing: Does Approach Matter?
| NCT number | NCT01879215 |
| Other study ID # | 817841 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | June 2013 |
| Est. completion date | July 2020 |
| Verified date | July 2020 |
| Source | University of Pennsylvania |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | July 2020 |
| Est. primary completion date | March 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 21 Years to 50 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| University of Pennsylvania | Synthes USA HQ, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 (T1? 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 | 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. | Pre-op, 2 week scan, 6 months post discharge | |
| Secondary | SMFA | MFA46A Injury and Arthritis Survey | Pre-op, 2 week scan, 6 months post discharge |