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

Trial Summary

What is the purpose of this trial?

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 of patients who have an open fracture in the mid tibia. Both groups will undergo primary fixation via reamed intramedulary nailing (IMN), a common treatment for tibia shaft fractures in adults. The study group will have a bone graft applied to the open cortex of the fracture. The bone graft will be composed of the intramedullary reamings, which are a byproduct produced when the intramedullary canal is reamed in preparation for insertion of the IMN.

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 data supports the idea that Intramedullary Bone Grafting for Tibial Fractures is an effective treatment?

The available research shows that Intramedullary Bone Grafting for Tibial Fractures is effective. 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 experiencing a lasting poor result. This suggests that the treatment is successful for most patients. Additionally, another study highlights that combining intramedullary nailing with bone grafting can effectively treat tibial fracture nonunion, which is when a fracture doesn't heal properly. These findings support the effectiveness of this treatment for tibial fractures. ^{1 2 3 4 5}

What safety data is available for intramedullary bone grafting in tibial fractures?

The safety data for intramedullary bone grafting in tibial fractures includes findings from several studies. Reamed intramedullary nailing is effective for most tibial fractures, with a high union rate and minimal need for additional bone grafting in aseptic nonunions. Complications such as dropped hallux and postoperative compartment syndrome occurred in 0.8% and 1.6% of cases, respectively. Anterior knee pain was reported in 42% of patients, but nail removal did not alleviate symptoms in nearly half of these cases. There is a low incidence of intraoperative complications, such as medullary tube fractures. The SPRINT trial identified factors associated with adverse events within one year of surgery, providing further insights into safety considerations. ^{1 2 4 6 7}

Is Intramedullary Bone Graft a promising treatment for tibial fractures?

Yes, Intramedullary Bone Graft is a promising treatment for tibial fractures. It is part of a well-established method called intramedullary nailing, which has shown very good results in healing tibial fractures. Most patients experience good recovery, and the treatment is effective for a wide range of fracture types. ^{1 2 3 4 8}

Research Team

Rodolfo Zamora, MD

Principal Investigator

University of Louisville

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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 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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

Multiple fracture of medullary tube during intramedullary nailing of long bone fractures. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Tibial shaft fractures treated with intramedullary nailing. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

The role of acupuncture in pain and swelling control for postoperative tibial fracture treatment. [2022]

5. China pubmed.ncbi.nlm.nih.gov

[Pressure interlocking intramedullary nailing fixation and bone grafting for treatment of tibial fracture nonunion]. [2012]

6. India 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? [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Prognostic factors for predicting outcomes after intramedullary nailing of the tibia. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Extending the Indication of Intramedullary Nailing of Tibial Fractures. [2016]