Pseudoarthrosis of BoneNCT05423561
Corticalisation After Femoral Nail Dynamization in Hypertrophic Non-unions
A study testing exchange nailing with larger, thicker nail crossing corticalization in people with Pseudoarthrosis of Bone and Implant Breakage, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization.
Trial summary
In 12 patients with corticalization and hypertrophic pseudarthrosis were present after dynamization, the old nail was removed and nail exchange was performed with a longer and larger diameter nail to pass the region formed in the cortex approximately 2-3cm inferior from the old nail. Read more about this study
- Who is it for?
- Ages 28 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Pseudoarthrosis of Bone, Implant Breakage
- What is being tested?
- exchange nailing with larger, thicker nail crossing corticalization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 5 May 2022
- 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 28 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subtrochanteric fractures
- Nonunion with Pain
Who cannot join
- Infection
- Pathological Fracture (Tumor)
About this study
Official title: Sclerotic Bone Formation (Corticalisation) on the Intramedullar Nail Tip in Hypertrophic Non-union Developing After Femoral Transverse Diaphyseal Fractures
In 12 patients with corticalization and hypertrophic pseudarthrosis were present after dynamization, the old nail was removed and nail exchange was performed with a longer and larger diameter nail to pass the region formed in the cortex approximately 2-3cm inferior from the old nail.
Read the detailed description
Corticalization is cortex-like sclerosis in the distal of the nail and it may indicate the early sign of dynamization treatment failure in hypertrophic nonunion after femoral transverse diaphyseal fractures. When corticalization is seen during follow-up after dynamization is performed because of non-union of a femoral transverse fracture, nail exchange should be performed without further delay. More rigid fixation should be applied with a longer and thicker nail crossing the area of corticalization.
- Conditions
- Pseudoarthrosis of Bone, Implant Breakage
- Being tested
- exchange nailing with larger, thicker nail crossing corticalization
- Keywords
- hypertrophic pseudarthrosis, dynamization, corticalisation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exchange nailing with larger, thicker nail crossing corticalizationProcedure or surgery
exchange nailing with larger, thicker nail crossing corticalization
| Study group | Role | What they receive |
|---|---|---|
| hypertrophic non-union developing after femoral transverse diaphyseal fractures | Other | Not described Receives: Procedure: exchange nailing with larger, thicker nail crossing corticalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Provide Bone Union
Achievement of bone union with detecting callus formation on radiography after passing the region of corticalisation with a longer and thicker nail
Measured: 6 months
Relieving pain in the nonunion area
Detection of reduction of pain scores in the nonunion area and enabling patients to load on the extremity in the early period postoperatively
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start1 Jan 2010
- Primary completion31 Jul 2020
- Study completion5 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pseudoarthrosis of BoneStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Çağrı Tekin, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05423561
- Sponsor's protocol ID
- E-48670771-514.99
- Other IDs
- 67
- Status last verified
- Jun 2022
- First submitted
- 9 Jun 2022
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sclerotic Bone Formation (Corticalisation) on the Intramedullar Nail Tip in Hypertrophic Non-union Developing After Femoral Transverse Diaphyseal Fractures
- ClinicalTrials.gov ID
- NCT05423561
- Acronym / sponsor ID
- E-48670771-514.99
- Conditions
- Pseudoarthrosis of Bone, Implant Breakage
- Keywords
- hypertrophic pseudarthrosis, dynamization, corticalisation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 5 May 2022 (actual)
- First posted
- 21 Jun 2022 (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.
In 12 patients with corticalization and hypertrophic pseudarthrosis were present after dynamization, the old nail was removed and nail exchange was performed with a longer and larger diameter nail to pass the region formed in the cortex approximately 2-3cm inferior from the old nail.
Detailed description
Corticalization is cortex-like sclerosis in the distal of the nail and it may indicate the early sign of dynamization treatment failure in hypertrophic nonunion after femoral transverse diaphyseal fractures. When corticalization is seen during follow-up after dynamization is performed because of non-union of a femoral transverse fracture, nail exchange should be performed without further delay. More rigid fixation should be applied with a longer and thicker nail crossing the area of corticalization.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hypertrophic non-union developing after femoral transverse diaphyseal fractures | Other | Procedure: exchange nailing with larger, thicker nail crossing corticalization |
Who may qualify
- Ages
- 28 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subtrochanteric fractures
- Nonunion with Pain
Key exclusion criteria (2 listed)
- Infection
- Pathological Fracture (Tumor)
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 |
|---|---|---|
| exchange nailing with larger, thicker nail crossing corticalizationexchange nailing with larger, thicker nail crossing corticalization | Procedure or surgery | hypertrophic non-union developing after femoral transverse diaphyseal fractures |
Primary outcome
Provide Bone Union
Time frame: 6 months
Achievement of bone union with detecting callus formation on radiography after passing the region of corticalisation with a longer and thicker nail
Relieving pain in the nonunion area
Time frame: 6 weeks
Detection of reduction of pain scores in the nonunion area and enabling patients to load on the extremity in the early period postoperatively
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 21 Jun 2022.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing exchange nailing with larger, thicker nail crossing corticalization in people with Pseudoarthrosis of Bone and Implant Breakage, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization.
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 2 inclusion and 2 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 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Provide Bone Union (time frame: 6 months). 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?
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 21 Jun 2022.