Periprosthetic Plate Over Humeral Nail

NCT ID: NCT06812195

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2026-03-01

Brief Summary

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

Detailed Description

small IM interlocking nail, such as humeral nail, could be used in femoral fixation in normal adolescent patients due to the advantages of the entry point lateral to tip of greater trochanter resulting in avoiding iatrogenic vascular injury and being the IM locking device with smaller diameter and shorter length than conventional femoral nail which was appropriate for small-sized adolescent femoral anatom

Conditions

Osteopenia, Osteoporosis

Study Design

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

Study Groups

plate over humeral nail

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

Group Type: EXPERIMENTAL

Plate and nail

Intervention Type: 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

Interventions

Plate and nail

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Hesham Mohamed Elbaseet

Lecturer of orthopedics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hesham M Elbaseet, MD

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

Hesham m Elbaseet, MD

Role: CONTACT

drhesham20@aun.edu.eg

201007780689 ext. 20

References

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.

Reference Type: BACKGROUND

PMID: 15289686 (View on PubMed)

Other Identifiers

PPOND

Identifier Type: OTHER

Identifier Source: secondary_id

PPON

Identifier Type: -

Identifier Source: org_study_id