Skip to main content
OpenTrials
Completed

NCT Number: NCT07561788

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Revision using a composite graft

Procedure

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

Primary outcomes

  1. Radiographic union of the fractures

    Time frame: 6 months post-procedure

    Radiographic 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 outcomes

  1. Time to union

    Time frame: Till 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.

  2. Degree of pain

    Time frame: 12 months post-procedure

    Pain 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.

  3. Incidence of postoperative complications

    Time frame: 12 months post-procedure

    Incidence of postoperative complications were recorded.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 1, 2026
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.