Corticalisation After Femoral Nail Dynamization in Hypertrophic Non-unions

Not Applicable

Completed

• Conditions: Implant Breakage; Pseudoarthrosis of Bone
• Interventions: Procedure: exchange nailing with larger, thicker nail crossing corticalization

• Registration Number: NCT05423561
• Lead Sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

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 Timeline

• Study Start: 2010-01-01
• Primary Completion: 2020-07-31
• Study Completion: 2022-05-05
• Status Verified: 2022-06
• Study First Submitted: 2022-06-09
• Study First Submitted QC: 2022-06-14
• Last Update Submitted: 2022-06-14
• Study First Posted: 2022-06-21
• Last Update Posted: 2022-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Subtrochanteric fractures
• Nonunion with Pain

Exclusion Criteria

• Infection
• Pathological Fracture (Tumor)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
hypertrophic non-union developing after femoral transverse diaphyseal fractures	exchange nailing with larger, thicker nail crossing corticalization	-

Primary Outcome Measures

Name	Time	Method
Provide Bone Union	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	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