An observational study in Cancellous Bone Autograft, Bone Substitute and Local Antibiotic, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by Tanta University · Observational
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.
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).
159 studies on the registry are indexed under Tibial Fractures; 40 are open to participants now.
This study's enrollment of 25 is below the median of 83 across 46 observational studies indexed under Tibial Fractures.
Browse Tibial Fractures studies →Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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This retrospective trial was performed on 25 adult individuals underwent revision surgery for non-union of femoral or tibial shaft fractures following definitive fixation by intramedullary nails or Illizarov fixators according to the local potential infection presence.
Exclusion Criteria:
- Patients with pathological fractures, infection, or comorbidities that interfere with healing.
Adult individuals underwent revision surgery for non-union of femoral or tibial shaft fractures following definitive fixation by intramedullary nails or Illizarov fixators
Procedure: Revision using a composite graft
All patients underwent revision using a composite graft and either retained intramedullary nails or Ilizarov fixators.
Radiographic union of the fractures
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.
Time frame: 6 months post-procedure
Time to union
Time to union was defined as the duration from surgery to the radiographic evidence of full fracture healing.
Time frame: Till full fracture healing (Up to 6 months)
Degree of pain
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.
Time frame: 12 months post-procedure
Incidence of postoperative complications
Incidence of postoperative complications were recorded.
Time frame: 12 months post-procedure
Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Tanta University