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Corticalisation After Femoral Nail Dynamization in Hypertrophic Non-unions

Sclerotic Bone Formation (Corticalisation) on the Intramedullar Nail Tip in Hypertrophic Non-union Developing After Femoral Transverse Diaphyseal Fractures

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05423561
Enrollment
12
Registered
2022-06-21
Start date
2010-01-01
Completion date
2022-05-05
Last updated
2022-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Implant Breakage, Pseudoarthrosis of Bone

Keywords

hypertrophic pseudarthrosis, dynamization, corticalisation

Brief 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.

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.

Interventions

PROCEDUREexchange nailing with larger, thicker nail crossing corticalization

exchange nailing with larger, thicker nail crossing corticalization

Sponsors

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
28 Years to 49 Years
Healthy volunteers
Yes

Inclusion criteria

* Subtrochanteric fractures * Nonunion with Pain

Exclusion criteria

* Infection * Pathological Fracture (Tumor)

Design outcomes

Primary

MeasureTime frameDescription
Provide Bone Union6 monthsAchievement 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 area6 weeksDetection of reduction of pain scores in the nonunion area and enabling patients to load on the extremity in the early period postoperatively

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026