Periprosthetic Plate Over Humeral Nail

NCT06812195 | Not Yet Recruiting

• 2 other identifiers: PPONPPOND
• Study Type: interventional
• Target: 3
• Locations: 0 countries
• Sites: N/A

Brief Summary

use of plate over humeral nail in deformity correction of femur in adult osteoporotic bone

Conditions

Osteopenia, Osteoporosis

Keywords

deformity; osteoporosis

Outcome Measures

Primary Outcomes (1)

• Metal failure

  Number of cases with bending or protrusion

  2 years

Study Arms (1)

plate over humeral nail

EXPERIMENTAL

spinal anesthesia in supine position, lateral approach to the femur is used to do corrective osteotomies and introduction of nail according to preoperative plan. After that, plate is applied to lateral border to the feoral shaft

Device: Plate and nail

Interventions

Plate and nail DEVICE

spinal anesthesia in supine position, lateral approach to the femur is used to do corrective osteotomies and introduction of nail according to preoperative plan. After that, plate is applied to lateral border to the femoral shaft

plate over humeral nail

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Osteoporotic bone with femoral deformity.
• Osteogenesis imperfecta. --Vitamin D deficiency ricket

You may not qualify if:

• Uncooperative patient.
• \-- Skeletally immature
• Not receiving medical treatment.
• Patient with history of allergy to drugs used in the study.
• Neuromuscular pathology, previous trauma, or surgery to the leg

Sponsors & Collaborators

• Assiut University: lead

Related Publications (1)

• Gordon JE, Khanna N, Luhmann SJ, Dobbs MB, Ortman MR, Schoenecker PL. Intramedullary nailing of femoral fractures in children through the lateral aspect of the greater trochanter using a modified rigid humeral intramedullary nail: preliminary results of a new technique in 15 children. J Orthop Trauma. 2004 Aug;18(7):416-22; discussion 423-4. doi: 10.1097/00005131-200408000-00004.

  PMID: 15289686 BACKGROUND

MeSH Terms

Conditions

Bone Diseases, Metabolic; Congenital Abnormalities; Osteoporosis

Interventions

Bone Plates

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Internal Fixators; Prostheses and Implants; Equipment and Supplies; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Surgical Fixation Devices

Study Officials

• Hesham M Elbaseet, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hesham m Elbaseet, MD

CONTACT

201007780689; drhesham20@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of orthopedics

Model Details: Under spinal anesthesia in supine position, lateral approach to the femur is used to do corrective osteotomies and introduction of humeral nail according to preoperative plan. After that, plate is applied to lateral border to the feoral shaft. Weight bearing is allowed after confirmation of union after 6 weeks. Regular visits every 3 months.

Study Record Dates

• First Submitted: February 1, 2025
• First Posted: February 6, 2025
• Study Start: March 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share