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
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tanta University
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Radiographic union of the fractures
Overview
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).
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Study group
Adult individuals underwent revision surgery for non-union of femoral or tibial shaft fractures following definitive fixation by intramedullary nails or Illizarov fixators
Intervention: Revision using a composite graft (Procedure)
Outcomes
Primary Outcomes
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
- Time to union(Till full fracture healing (Up to 6 months))
- Degree of pain(12 months post-procedure)
- Incidence of postoperative complications(12 months post-procedure)
Investigators
Ahmed Gamal Ismaiel
Lecturer of Orthopedic Surgery, Tanta University, Tanta, Egypt
Tanta University