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CompletedNCT05423561Updated Jun 21, 2022

Corticalisation After Femoral Nail Dynamization in Hypertrophic Non-unions

An interventional study of exchange nailing with larger, thicker nail crossing corticalization in Pseudoarthrosis of Bone and Implant Breakage, sponsored by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization. Completed. Open to participants aged 28 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-21.

Sponsored by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 12 years 5 months after the study started (first participant enrolled Jan 2010, registered Jun 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
28 Years to 49 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Pseudoarthrosis of Bone
  • Implant Breakage

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Keywords

  • hypertrophic pseudarthrosis
  • dynamization
  • corticalisation
03

In context

Pseudarthrosis

41 studies on the registry are indexed under Pseudarthrosis; 7 are open to participants now.

This study's enrollment of 12 is below the median of 22 across 25 interventional studies indexed under Pseudarthrosis.

Browse Pseudarthrosis studies →

Lead sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization is the lead sponsor of 87 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
28 Years to 49 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subtrochanteric fractures
  • Nonunion with Pain

Exclusion criteria

Exclusion Criteria:

  • Infection
  • Pathological Fracture (Tumor)
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Other
    hypertrophic non-union developing after femoral transverse diaphyseal fractures

    Procedure: exchange nailing with larger, thicker nail crossing corticalization

Interventions

  • Procedureexchange nailing with larger, thicker nail crossing corticalization

    exchange nailing with larger, thicker nail crossing corticalization

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 6 months

  2. 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

    Time frame: 6 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2010 to primary completion in Jul 2020, 126 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 9, 2022
First posted
Jun 21, 2022
StartActual
Jan 1, 2010
Primary completionActual
Jul 31, 2020
CompletionActual
May 5, 2022
Last update
Jun 21, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05423561
Lead sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Responsible party
Ali Çağrı Tekin (Associated Professor, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization) — Principal investigator
First posted
Jun 21, 2022
Start date
Jan 1, 2010
Primary completion
Jul 31, 2020
Completion
May 5, 2022
Last update
Jun 21, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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