Corticalisation After Femoral Nail Dynamization in Hypertrophic Non-unions

NCT ID: NCT05423561

Last Updated: 2022-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-01
• Study Completion Date: 2022-05-05

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.

Conditions

Pseudoarthrosis of Bone; Implant Breakage

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

hypertrophic non-union developing after femoral transverse diaphyseal fractures

Group Type: OTHER

exchange nailing with larger, thicker nail crossing corticalization

Intervention Type: PROCEDURE

exchange nailing with larger, thicker nail crossing corticalization

Interventions

exchange nailing with larger, thicker nail crossing corticalization

exchange nailing with larger, thicker nail crossing corticalization

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Subtrochanteric fractures
• Nonunion with Pain

Exclusion Criteria

• Infection
• Pathological Fracture (Tumor)

• Minimum Eligible Age: 28 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

OTHER

Sponsor Role: lead

Responsible Party

Ali Çağrı Tekin

Associated Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

67

Identifier Type: REGISTRY

Identifier Source: secondary_id

E-48670771-514.99

Identifier Type: -

Identifier Source: org_study_id