Ignite Creation Date:
2025-12-24 @ 12:39 PM
Ignite Modification Date:
2026-02-22 @ 4:53 PM
Study NCT ID:
NCT05423561
Status:
COMPLETED
Last Update Posted:
2022-06-21
First Post:
2022-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Corticalisation After Femoral Nail Dynamization in Hypertrophic Non-unions
Sponsor:
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Organization:
Study Overview
Official Title:
Sclerotic Bone Formation (Corticalisation) on the Intramedullar Nail Tip in Hypertrophic Non-union Developing After Femoral Transverse Diaphyseal Fractures
Status:
COMPLETED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 67 | REGISTRY | Desicion number | View |