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

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.

Study Overview

• Status: Completed
• Conditions: Pseudoarthrosis of Bone; Implant Breakage
• Intervention / Treatment: Procedure: exchange nailing with larger, thicker nail crossing corticalization

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subtrochanteric fractures
• Nonunion with Pain

Exclusion Criteria:

• Infection
• Pathological Fracture (Tumor)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: hypertrophic non-union developing after femoral transverse diaphyseal fractures	Procedure: exchange nailing with larger, thicker nail crossing corticalization; exchange nailing with larger, thicker nail crossing corticalization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): July 31, 2020
• Study Completion (Actual): May 5, 2022

Study Registration Dates

• First Submitted: June 9, 2022
• First Submitted That Met QC Criteria: June 14, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 14, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: hypertrophic pseudarthrosis; dynamization; corticalisation
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Pathological Conditions, Anatomical; Fractures, Ununited; Hypertrophy; Pseudarthrosis
• Other Study ID Numbers: E-48670771-514.99; 67 (Desicion number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No