Corticalisation After Femoral Nail Dynamization in Hypertrophic Non-unions

Pseudoarthrosis of Bone Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05423561
• Other study ID #: E-48670771-514.99
• Secondary ID: 67
• Status: Completed
• Phase: N/A
• Start date: January 1, 2010
• Est. completion date: May 5, 2022

Study information

• Verified date: June 2022
• Source: Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 5, 2022
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 28 Years to 49 Years

Eligibility

Inclusion Criteria:

• Subtrochanteric fractures

• Nonunion with Pain

Exclusion Criteria:

• Infection

• Pathological Fracture (Tumor)

Related Conditions & MeSH terms

• Hypertrophy
• Implant Breakage
• Pseudarthrosis
• Pseudoarthrosis of Bone

Intervention

Procedure:
• exchange nailing with larger, thicker nail crossing corticalization
exchange nailing with larger, thicker nail crossing corticalization

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months
Primary	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	6 weeks