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OpenTrials
Completed

NCT Number: NCT05423561

Corticalisation After Femoral Nail Dynamization in Hypertrophic Non-unions

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.

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Key information

Conditions

Pseudoarthrosis of Bone Implant Breakage

Age range

28 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subtrochanteric fractures
  • Nonunion with Pain

Exclusion criteria

  • Infection
  • Pathological Fracture (Tumor)

Treatment and study plan

exchange nailing with larger, thicker nail crossing corticalization

Procedure

exchange nailing with larger, thicker nail crossing corticalization

Primary outcomes

  1. Provide Bone Union

    Time frame: 6 months

    Achievement of bone union with detecting callus formation on radiography after passing the region of corticalisation with a longer and thicker nail

  2. Relieving pain in the nonunion area

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2020
Study completion
2022
First posted
Jun 21, 2022
Registry last updated
Jun 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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