Cancellous Bone AutograftNCT07561788
Cancellous Bone Autograft, Bone Substitute, Local Antibiotic, and Fresh Blood for Ununited Fixed Femoral and Tibial Fractures
An observational study of Cancellous Bone Autograft and Bone Substitute, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cancellous Bone Autograft, Bone Substitute, Local Antibiotic
- What is being tested?
- Revision using a composite graft
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2023to 1 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- Patients with pathological fractures, infection, or comorbidities that interfere with healing.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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).
- Conditions
- Cancellous Bone Autograft, Bone Substitute, Local Antibiotic, Fresh Blood, Ununited Fixed Femoral and Tibial Fractures
- Being tested
- Revision using a composite graft
- Medical subject headings
- Tibial Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revision using a composite graftProcedure or surgery
All patients underwent revision using a composite graft and either retained intramedullary nails or Ilizarov fixators.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Revision using a composite graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months post-procedure
Secondary outcomes (3)
Time to union
Time to union was defined as the duration from surgery to the radiographic evidence of full fracture healing.
Measured: 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.
Measured: 12 months post-procedure
Incidence of postoperative complications
Incidence of postoperative complications were recorded.
Measured: 12 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start1 Jul 2023
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancellous Bone AutograftStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Gamal Ismaiel, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07561788
- Sponsor's protocol ID
- 3626PR706/5/24
- Status last verified
- Apr 2026
- First submitted
- 25 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07561788
- Acronym / sponsor ID
- 3626PR706/5/24
- Conditions
- Cancellous Bone Autograft, Bone Substitute, Local Antibiotic, Fresh Blood, Ununited Fixed Femoral and Tibial Fractures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Procedure: Revision using a composite graftAdult individuals underwent revision surgery for non-union of femoral or tibial shaft fractures following definitive fixation by intramedullary nails or Illizarov fixators |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with pathological fractures, infection, or comorbidities that interfere with healing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Revision using a composite graftAll patients underwent revision using a composite graft and either retained intramedullary nails or Ilizarov fixators. | Procedure or surgery | Study group |
Primary outcome
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.
3 secondary outcomes
Time to union
Time frame: Till full fracture healing (Up to 6 months)
Degree of pain
Time frame: 12 months post-procedure
Incidence of postoperative complications
Time frame: 12 months post-procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancellous Bone Autograft and Bone Substitute, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic union of the fractures (time frame: 6 months post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.