Intramedullary Bone Grafting for Tibial Fractures

Overseen By Salwa M Rashid, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Louisville

Disqualifiers: Under 18, Pregnant, Quadriplegia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: Immediate post-injury

130 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for treating open tibia fractures, where the shinbone breaks through the skin. The study compares two groups: one receiving standard treatment with metal rods (intramedullary nailing) and the other receiving the same treatment plus a bone graft to aid healing. The goal is to determine if the bone graft accelerates fracture healing. Individuals with an open fracture in the middle of the shinbone, who can have the wound closed during their first surgery, might be suitable for this trial. As an unphased trial, this study provides a unique opportunity to contribute to medical knowledge and potentially benefit from innovative treatment.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that intramedullary bone grafting is safe for tibial fractures?

Research has shown that intramedullary bone grafting is generally well-tolerated. In a study with 132 patients who had fractures in the main part of their shinbone, 96% experienced good or fair results after receiving this treatment. Only one patient experienced a negative effect, indicating that problems are rare. This treatment involves a common procedure for fixing shinbone fractures and adds bone grafting from the material removed during the process. While specific side effects weren't detailed, the high percentage of positive results suggests it is safe for most patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about intramedullary bone grafting for tibial fractures because it adds a crucial element to standard fracture care. While the typical treatment involves cleaning the fracture and stabilizing it with a metal rod, this technique includes a bone graft to aid in healing. The bone graft may help the fracture heal faster and more robustly by providing additional biological support to the broken bone. This approach could potentially reduce recovery time and improve outcomes for patients with tibial fractures.

What evidence suggests that intramedullary bone grafting is effective for tibial fractures?

Research has shown that using bone grafts inside the bone for broken shinbones (tibial fractures) is promising. One study with 132 patients found that 96% had good or fair results after treatment with a method called intramedullary nailing. In this trial, participants in the intervention group will receive a bone graft in addition to standard treatment, which includes intramedullary nailing. This technique uses bone material collected during the procedure to aid healing. The bone graft fills gaps and supports recovery. Overall, evidence suggests this method can effectively improve healing in broken shinbones. ^{1 2 3 6 7}

Who Is on the Research Team?

Rodolfo Zamora, MD

Principal Investigator

University of Louisville

Are You a Good Fit for This Trial?

Adults with a specific type of broken tibia (shinbone) called an open fracture, who can have the wound closed during initial surgery and are willing to follow up for 6-9 months. Not for those under 18, pregnant women, patients with certain bone conditions or fractures, or individuals with quadriplegia or paraplegia.

Inclusion Criteria

Consent to participate in the study.

You have a broken shinbone that can be treated with a metal rod and the fracture is classified as Gustillo I, II, or IIIa.

Patient age 18 or older

Exclusion Criteria

You have skin problems on your shin that cannot be fully closed.

You are pregnant.

Patients under the age of 18.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo irrigation and debridement of the open fracture, reamed intramedullary nailing, and primary wound closure. The intervention group also receives a bone graft on the exposed cortex of the tibial fracture.

Immediate post-injury

1 visit (in-person)

Follow-up

Participants receive follow-up care with clinic visits and X-rays to monitor fracture union and functional outcomes.

24 weeks

4 visits (in-person) at 2, 8, 16, and 24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Intramedullary Bone Graft

Trial Overview The trial is testing if adding a bone graft made from reamed-out bone material to standard treatment helps bones heal faster in adults. Participants will be randomly divided into two groups; one receives the graft along with regular nail fixation treatment.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Patients in this group will receive a bone graft in addition to the undergoing standard treatment for their open tibia shaft fracture (irrigation and debridement of their open fracture and reamed intramedullary nailing)

Group II: Control Active Control 1 Intervention

Patients in this group will undergo standard treatment for their open tibia shaft fracture (irrigation and debridement of their open fracture and reamed intramedullary nailing)

Intramedullary Bone Graft is already approved in United States, European Union for the following indications:

Approved in United States as Intramedullary Bone Grafting for:

• Open tibial shaft fractures
• Nonunion of tibial fractures

Approved in European Union as Intramedullary Bone Grafting for:

• Open tibial shaft fractures
• Nonunion of tibial fractures

Who Is Running the Clinical Trial?

University of Louisville

Lead Sponsor

Trials

353

Recruited

76,400+

Published Research Related to This Trial

In a study of 18 patients with tibial fracture nonunion, treatment using pressurized intramedullary nailing combined with bone grafting from the nailing site resulted in successful healing without complications such as infection or re-fracture.

The average healing time was 6 months, and knee function improved significantly, with most patients achieving excellent or good outcomes according to the Tenny-Wiss scoring system, demonstrating the efficacy of this treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pressure interlocking intramedullary nailing fixation and bone grafting for treatment of tibial fracture nonunion]. Ding, LZ., Xia, NX.[2012]

In a study of 31 patients with tibial shaft aseptic nonunions, the use of reamed intramedullary nails without additional cancellous bone grafting resulted in a 100% success rate for achieving solid bone union, with a median union time of 4.5 months.

This technique not only simplifies the surgical process by eliminating the need for bone grafting but also shows no significant complications, suggesting it is a safe and effective treatment option for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reaming bone grafting to treat tibial shaft aseptic nonunion after plating. Wu, CC.[2017]

Intramedullary nailing is a proven and effective treatment for various types of tibial fractures, demonstrating its reliability in surgical practice.

Recent advancements in surgical techniques have improved the application of intramedullary nailing, making it a viable option for more complex cases, such as metaphyseal and open fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extending the Indication of Intramedullary Nailing of Tibial Fractures. Kuhn, S., Hansen, M., Rommens, PM.[2016]

In a study of 1226 patients with tibial shaft fractures, factors such as high-energy injury mechanisms, the use of stainless steel nails, and the presence of a fracture gap were associated with an increased risk of negative postoperative outcomes.

Patients with open fractures treated with reamed nailing had a significantly higher risk of adverse events, but those who received effective wound management had a lower risk compared to those needing complex reconstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognostic factors for predicting outcomes after intramedullary nailing of the tibia. Schemitsch, EH., Bhandari, M., Guyatt, G., et al.[2022]

In a study of 233 patients with 247 tibial fractures, reamed intramedullary nailing resulted in a 96% union rate after an average of 4.9 years, demonstrating its efficacy for treating tibial fractures.

Bone grafting during intramedullary nailing did not improve healing rates in tibial nonunions, indicating that it may not be necessary in most cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reamed interlocking intramedullary nailing for the treatment of tibial diaphyseal fractures and aseptic nonunions. Can we expect an optimum result? Chalidis, BE., Petsatodis, GE., Sachinis, NC., et al.[2022]

Intramedullary nailing is a common and accepted method for fixing femoral and tibial shaft fractures, but it carries a risk of intraoperative complications.

This study presents two new cases of medullary tube fractures during the procedure, highlighting a potential complication that has been rarely reported in the literature.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiple fracture of medullary tube during intramedullary nailing of long bone fractures. Vakharia, MR., Lehto, SA., Mohler, DG.[2019]

Electro-acupuncture significantly reduces pain in patients after tibial fracture surgery, showing a notable analgesic effect within 24-48 hours post-operation, with a statistically significant difference in pain scores compared to the control group.

While electro-acupuncture improved pain management, it did not have a significant impact on bone healing compared to standard care, indicating it is a safe and effective adjunct treatment with minimal side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of acupuncture in pain and swelling control for postoperative tibial fracture treatment. Quoc, LT., Thanh, HNT., Le Khanh, T., et al.[2022]

In a study of 132 patients with 139 tibial shaft fractures treated with intramedullary nailing, 96% of the patients achieved good or fair results at follow-up, indicating high efficacy of this treatment method.

Only one patient experienced a lasting poor outcome, suggesting that intramedullary nailing is a safe and effective option for managing tibial shaft fractures, with most patients healing well.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tibial shaft fractures treated with intramedullary nailing. Solheim, K., Bøo, O., Langård, O.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT03891888?draw=2&rank=1

Intramedullary Bone Grafting for Open Tibial Shaft Fractures This study will examine if there is a difference between the time to full union between the control group and the study group. Each group will be composed ...

2. withpower.com withpower.com/trial/phase-fractures-bone-2-2020-4e740

Intramedullary Bone Grafting for Tibial Fractures In a study of 132 patients with tibial shaft fractures treated with intramedullary nailing, 96% of the patients had good or fair results, with only one patient ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT03891888/intramedullary-bone-grafting-for-open-tibial-shaft-fractures

Intramedullary Bone Grafting for Open Tibial Shaft Fractures This study will examine if there is a difference between the time to full union between the control group and the study group.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10362687/

Comparison of mini-open reduction and autologous bone ... In conclusion, GM is safe and effective for the treatment of tibial shaft fracture. While closed reduction and intramedullary nailing continue to be the ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2773157X25002401

Treatment of diaphyseal tibial fracture nonunion with an ... Randomized trial of reamed and unreamed intramedullary nailing of tibial shaft fractures. J Bone Joint Surg Am, 90 (12) (2008), pp. 2567-2578.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2446397/

Study to prospectively evaluate reamed intramedually nails in ... The objective of this trial was to assess the impact of reamed versus non-reamed intramedullary nailing on rates of re-operation in patients with open and ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6734623/

Treatment of high‐energy tibial shaft fractures with internal ... Objective: To evaluate the safety and efficacy of early NovaBone grafting in accelerating healing of high‐energy tibial shaft fractures.