Acute Tibial Fracture Requiring Intramedullary NailingNCT01879215
T1Rho MRI Evaluation of Patellofemoral Changes After Tibial IM Nailing
A study testing Intramedullary nailing of the tibia in people with Acute Tibial Fracture Requiring Intramedullary Nailing, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Acute Tibial Fracture Requiring Intramedullary Nailing
- What is being tested?
- Intramedullary nailing of the tibia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Patella Femoral Changes Following Tibial Nailing: Does Approach Matter?
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.
- Being tested
- Intramedullary nailing of the tibia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intramedullary nailing of the tibiaProcedure or surgery
Standard care surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Intramedullary nailing of the tibia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 months post-discharge
Secondary outcomes (2)
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.
Measured: Pre-op, 2 week scan, 6 months post discharge
SMFA
MFA46A Injury and Arthritis Survey
Measured: Pre-op, 2 week scan, 6 months post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionMar 2020
- Study completionJul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Tibial Fracture Requiring Intramedullary NailingStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Synthes USA HQ, Inc.
- Responsible party
- Sponsor
- Investigators
- Samir Mehta, MD, Principal investigator, University of PennsylvaniaDerek Donegan, MD, Principal investigator, University of PennsylvaniaAnnamarie Horan, PhD, Study director, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01879215
- Sponsor's protocol ID
- 817841
- Status last verified
- Jul 2020
- First submitted
- 12 Jun 2013
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patella Femoral Changes Following Tibial Nailing: Does Approach Matter?
- ClinicalTrials.gov ID
- NCT01879215
- Acronym / sponsor ID
- 817841
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Synthes USA HQ, Inc.
- Study start
- Jun 2013
- Primary completion
- Mar 2020 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 17 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suprapatellar Approach | Active comparator | Procedure: Intramedullary nailing of the tibiaSuprapatellar 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 | Active comparator | Procedure: Intramedullary nailing of the tibiaInfrapatellar 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. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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,
Key exclusion criteria (13 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intramedullary nailing of the tibiaStandard care surgery | Procedure or surgery | Infrapatellar Approach, Suprapatellar Approach |
Primary outcome
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
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.
2 secondary outcomes
SF-36
Time frame: Pre-op, 2 week scan, 6 months post discharge
SMFA
Time frame: Pre-op, 2 week scan, 6 months post discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samir Mehta, MD principal investigator
University of Pennsylvania
Derek Donegan, MD principal investigator
University of Pennsylvania
Annamarie Horan, PhD study director
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intramedullary nailing of the tibia in people with Acute Tibial Fracture Requiring Intramedullary Nailing, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2020; AzTrials last refreshed its copy on 8 Nov 2026.