Fracture Non UnionNCT07207447
Validity of the Non-union Scoring System in Management of Long Bone Fracture Non-union
A study testing Improving the stability and re-fixation with different modalities, Re-fixation with biological stimulation and complex care with non-union resection and bone reconstruction in people with Fracture Non Union, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this study is to apply Calori Non union Scoring System on long bone non-union cases and evaluate the results of treatment o f the patients according to the score. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fracture Non Union
- What is being tested?
- Improving the stability and re-fixation with different modalities, Re-fixation with biological stimulation and complex care with non-union resection and bone reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Feb 2022to 10 Aug 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sex: both sexes.
- Age: Above 18 years old.
- Lesion: Tibial or femoral bone non-union.
Who cannot join
- Skeletal immaturity.
- Any immunosuppressive drug therapy.
- Autoimmune disease.
- Neoplasia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validity of the Non-union Scoring System in Management of Long Bone Fracture Non-union: A Prospective Study
The aim of this study is to apply Calori Non union Scoring System on long bone non-union cases and evaluate the results of treatment o f the patients according to the score.
Read the detailed description
The aim of this study is to apply Calori Non union Scoring System on long bone non-union cases and evaluate the results of treatment o f the patients according to the score. The study will be on patients with lower limb long bone diaphyseal fracture non-union. All patients will be assessed preoperatively by Clinical Evaluation: History, general examination, local examination, radiological evaluation: Plain X-ray films showing joint above and joint below the non-union site, laboratory Investigations: CBC, ESR, CRP and HbA1c. For patient allocation, patients will be divided into four groups according to the NUSS score, with group one (0-25 points) who underwent improving the stability and re-fixation with different modalities such as exchange plate with longer plate, intramedullary nailing, exchange nailing with larger diameter, plating over nail or dynamization of intramedullary nail. Group two (26-50 points) underwent re-fixation in addition to biological stimulation such as bone grafting, either with plate and bone graft, plate over nail and graft, or with external fixation with LRS or Ilizarov and grafting in one stage or two stages. Group three (51-75 points) required more complex care with resection of the non-union and dealing with the defect with bone transport, either direct transport or staged with cement spacer and later bone transport, Masquelet technique or acute compression and lengthening with another osteotomy. Group four (76-100 points) underwent amputation with consideration of prosthesis. The patients will be followed up at regular intervals as regard radiological and clinical evaluation until full union is achieved or non-union is established. The assessment includes; clinical and functional assessment based on pain at the fracture site and recovery of the usual activities or work, and radiological assessment based on plain radiograph x-rays, CT scan if needed to assess union. Radiological union is considered based on the presence of bridging callus (3/4 of cortices) in both anteroposterior and lateral views.
- Conditions
- Fracture Non Union
- Being tested
- Improving the stability and re-fixation with different modalities, Re-fixation with biological stimulation, complex care with non-union resection and bone reconstruction, Amputation
- Keywords
- NUSS, Non-union Scoring System, Fracture Non-Union, Bone defect
- Medical subject headings
- Fractures, Ununited
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Improving the stability and re-fixation with different modalitiesProcedure or surgery
Improving the stability and re-fixation with different modalities such as exchange plate with longer plate, intramedullary nailing, exchange nailing with larger diameter, plating over nail or dynamization of intramedullary nail.
Re-fixation with biological stimulationProcedure or surgery
Re-fixation with biological stimulation such as bone grafting, either with plate and bone graft, plate over nail and graft, or with external fixation with LRS or Ilizarov and grafting in one stage or two stages.
complex care with non-union resection and bone reconstructionProcedure or surgery
complex care with non-union resection and bone reconstruction, including resection of the non-union and dealing with the defect with bone transport, either direct transport or staged with cement spacer and later bone transport, Masquelet technique or acute compression and lengthening with another osteotomy.
AmputationProcedure or surgery
Amputation with consideration of prosthesis.
| Study group | Role | What they receive |
|---|---|---|
| NUSS group 1 | Active comparator | Not described Receives: Procedure: Improving the stability and re-fixation with different modalities |
| NUSS group 2 | Active comparator | Not described Receives: Procedure: Re-fixation with biological stimulation |
| NUSS group 3 | Active comparator | Not described Receives: Procedure: complex care with non-union resection and bone reconstruction |
| NUSS group 4 | Active comparator | Not described Receives: Procedure: Amputation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological Fracture Union
Radiological fracture union is considered based on the presence of bridging callus (3/4 of cortices) in both anteroposterior and lateral views in x rays.
Measured: According to each group ranging from 5 months in group 1, 7 in group 2 and up to 12 months in group 3
Clinical Fracture Union
Clinical fracture union assessment is based on presence or absence of pain at the fracture site.
Measured: According to each group ranging from 4 months in group 1, 6 in group 2 and up to 11 months in group 3.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start10 Feb 2022
- Primary completion10 Jul 2024
- Study completion10 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fracture Non UnionStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07207447
- Sponsor's protocol ID
- FMASU MD21/2022
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2025
- Last updated
- 6 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wafa TA, Al Kersh MA, Ghaly NAM, Ahmed AR, Rizk MH, Mahran MA. Validity of the non-union scoring system in management of long bone fracture non-union. A prospective study. Injury. 2026 Aug 19;57(10):113610. doi: 10.1016/j.injury.2026.113610. Online ahead of print.
PubMed 42632350
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of the Non-union Scoring System in Management of Long Bone Fracture Non-union: A Prospective Study
- ClinicalTrials.gov ID
- NCT07207447
- Acronym / sponsor ID
- FMASU MD21/2022
- Conditions
- Fracture Non Union
- Keywords
- NUSS, Non-union Scoring System, Fracture Non-Union, Bone defect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 10 Jul 2024 (actual)
- Study completion
- 10 Aug 2024 (actual)
- First posted
- 6 Oct 2025 (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.
The aim of this study is to apply Calori Non union Scoring System on long bone non-union cases and evaluate the results of treatment o f the patients according to the score.
Detailed description
The aim of this study is to apply Calori Non union Scoring System on long bone non-union cases and evaluate the results of treatment o f the patients according to the score. The study will be on patients with lower limb long bone diaphyseal fracture non-union. All patients will be assessed preoperatively by Clinical Evaluation: History, general examination, local examination, radiological evaluation: Plain X-ray films showing joint above and joint below the non-union site, laboratory Investigations: CBC, ESR, CRP and HbA1c. For patient allocation, patients will be divided into four groups according to the NUSS score, with group one (0-25 points) who underwent improving the stability and re-fixation with different modalities such as exchange plate with longer plate, intramedullary nailing, exchange nailing with larger diameter, plating over nail or dynamization of intramedullary nail. Group two (26-50 points) underwent re-fixation in addition to biological stimulation such as bone grafting, either with plate and bone graft, plate over nail and graft, or with external fixation with LRS or Ilizarov and grafting in one stage or two stages. Group three (51-75 points) required more complex care with resection of the non-union and dealing with the defect with bone transport, either direct transport or staged with cement spacer and later bone transport, Masquelet technique or acute compression and lengthening with another osteotomy. Group four (76-100 points) underwent amputation with consideration of prosthesis. The patients will be followed up at regular intervals as regard radiological and clinical evaluation until full union is achieved or non-union is established. The assessment includes; clinical and functional assessment based on pain at the fracture site and recovery of the usual activities or work, and radiological assessment based on plain radiograph x-rays, CT scan if needed to assess union. Radiological union is considered based on the presence of bridging callus (3/4 of cortices) in both anteroposterior and lateral views.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NUSS group 1 | Active comparator | Procedure: Improving the stability and re-fixation with different modalities |
| NUSS group 2 | Active comparator | Procedure: Re-fixation with biological stimulation |
| NUSS group 3 | Active comparator | Procedure: complex care with non-union resection and bone reconstruction |
| NUSS group 4 | Active comparator | Procedure: Amputation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Sex: both sexes.
- Age: Above 18 years old.
- Lesion: Tibial or femoral bone non-union.
Key exclusion criteria (4 listed)
- Skeletal immaturity.
- Any immunosuppressive drug therapy.
- Autoimmune disease.
- Neoplasia.
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 |
|---|---|---|
| Improving the stability and re-fixation with different modalitiesImproving the stability and re-fixation with different modalities such as exchange plate with longer plate, intramedullary nailing, exchange nailing with larger diameter, plating over nail or dynamization of intramedullary nail. | Procedure or surgery | NUSS group 1 |
| Re-fixation with biological stimulationRe-fixation with biological stimulation such as bone grafting, either with plate and bone graft, plate over nail and graft, or with external fixation with LRS or Ilizarov and grafting in one stage or two stages. | Procedure or surgery | NUSS group 2 |
| complex care with non-union resection and bone reconstructioncomplex care with non-union resection and bone reconstruction, including resection of the non-union and dealing with the defect with bone transport, either direct transport or staged with cement spacer and later bone transport, Masquelet technique or acute compression and lengthening with another osteotomy. | Procedure or surgery | NUSS group 3 |
| AmputationAmputation with consideration of prosthesis. | Procedure or surgery | NUSS group 4 |
Primary outcome
Radiological Fracture Union
Time frame: According to each group ranging from 5 months in group 1, 7 in group 2 and up to 12 months in group 3
Radiological fracture union is considered based on the presence of bridging callus (3/4 of cortices) in both anteroposterior and lateral views in x rays.
Clinical Fracture Union
Time frame: According to each group ranging from 4 months in group 1, 6 in group 2 and up to 11 months in group 3.
Clinical fracture union assessment is based on presence or absence of pain at the fracture site.
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 6 Oct 2025.
- Derived from this study: PubMed 42632350Wafa TA, Al Kersh MA, Ghaly NAM, Ahmed AR, Rizk MH, Mahran MA. Validity of the non-union scoring system in management of long bone fracture non-union. A prospective study. Injury. 2026 Aug 19;57(10):113610. doi: 10.1016/j.injury.2026.113610. Online ahead of print.
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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?
A study testing Improving the stability and re-fixation with different modalities, Re-fixation with biological stimulation and complex care with non-union resection and bone reconstruction in people with Fracture Non Union, run by Ain Shams 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 4 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 6 Oct 2025. 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?
Radiological Fracture Union (time frame: According to each group ranging from 5 months in group 1, 7 in group 2 and up to 12 months in group 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07207447, which also lists 1 linked publication.
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 6 Oct 2025.