Skip to content

Cancellous Bone Autograft, Bone Substitute, Local Antibiotic, and Fresh Blood for Ununited Fixed Femoral and Tibial Fractures

Assessment of Using Mixture of Cancellous Bone Autograft, Bone Substitute, Local Antibiotic and Fresh Blood as Effective Onlay Graft for Ununited Fixed Femoral and Tibial Fractures

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07561788
Enrollment
25
Registered
2026-05-01
Start date
2023-07-01
Completion date
2024-10-01
Last updated
2026-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Substitute, Cancellous Bone Autograft, Fresh Blood, Local Antibiotic, Ununited Fixed Femoral and Tibial Fractures

Brief summary

This study aimed to assess the clinical and radiological outcomes of the usage of autogenous bone graft mixed with bone substitute, fresh blood of patient and local antibiotic used as an onlay graft in treatment of nonunion or delayed union of fixed femoral and tibia fractures.

Detailed description

Fractures of long bones as femur and tibia are the third most common ones in orthopedics daily practice, these fractures are usually treated with intramedullary nails. Union is defined as the appearance bridging callus more than two cortices at the fracture site in the expected time frame for each fracture type which is about 25 weeks for long bones. Nonunion is a problem that has an impact on both patients and society as it may lead to depression, longer time-off work, poor functional outcomes, and cost burdens of secondary interventions to manage. Different strategies can be used for treatment of such cases. All measures used should follow the diamond concept which summarizes the core factors that need to be present to achieve bone healing. In particular, these factors relate to the optimization of the mechanical stability and biological environment (sufficient osteogenic and angiogenic cells, osteoconductive scaffolds and growth factors).

Interventions

PROCEDURERevision using a composite graft

All patients underwent revision using a composite graft and either retained intramedullary nails or Ilizarov fixators.

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Age from 18 to 70 years old. * Both sexes. * Patients with complete radiographic and clinical follow-up records for at least 12 months post-revision.

Exclusion criteria

\- Patients with pathological fractures, infection, or comorbidities that interfere with healing.

Design outcomes

Primary

MeasureTime frameDescription
Radiographic union of the fractures6 months post-procedureRadiographic follow-up included evaluating Radiographic Union Score for Tibial Fractures (RUST) were used system to objectively evaluate tibial fractures. RUST assesses union based on four radiographic features: the presence of callus formation, cortical bridging, trabecular bridging, and the degree of alignment at the fracture site. Each feature was scored individually on a scale of 0 to 4, with higher scores indicating better healing.

Secondary

MeasureTime frameDescription
Time to unionTill full fracture healing (Up to 6 months)Time to union was defined as the duration from surgery to the radiographic evidence of full fracture healing.
Degree of pain12 months post-procedurePain was assessed via visual analog scale (VAS), a widely used tool where patients rate their pain intensity on a scale from 0 to 10, with 0 being no pain and 10 being the worst possible pain.
Incidence of postoperative complications12 months post-procedureIncidence of postoperative complications were recorded.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 2, 2026