Evaluation of the Proximal Femoral Nail Antirotation With Cement Augmentation in Osteoporotic Femoral Neck Fractures

NCT01235169 | Unknown Phase 1

• 1 other identifier: WEIL02-HMO-CTIL
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open multicenter study, evaluating a new operative technique in femur neck fractures. The treatment consist of augmentated nails in cases of subtrochanteric or inter fracture due to osteoporosis.There two routine surgical techniques in femoral neck fractures:

1. 1.Insertion an intramedullary nail (without augmentation) to the bone.
2. 2.insertion a nail and metal plateto the bone. The major disadvantage of these methods is the relative high rate (4-10 precentages) of failure because of the femur head bone which is very brittle and osteoporotic.

Conditions

Proximal Femur Fracture

Outcome Measures

Primary Outcomes (1)

• Proportion of patients reaching union at the 3-month and 6-month follow up

  Proportion of patients reaching union at the 3-month and 6-month follow up will be assessed. Union is defined by both clinical evaluation-pain and weight bearing status, and radiological evaluation- three out of four cortices must be bridged as viewed on plain X-ray (AP and lateral views).

Study Arms (1)

Proximal Femoral Nail Antirotation

EXPERIMENTAL

Proximal Femoral Nail Antirotation(PFNA) with cement augmentation

Device: Proximal Femoral Nail Antirotation(PFNA) with cement augmentation

Interventions

Proximal Femoral Nail Antirotation(PFNA) with cement augmentation DEVICE

Proximal Femoral Nail Antirotation

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PFNA augmentation is indicated for severe osteoporotic fractures (Subtrochanteric or intertrochanteric) in the proximal femur.
• Men and women above 80 years old that fuffer from fracture in the proximal femur.

You may not qualify if:

• Patient can not come to the follow up clinic visits.

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organizaton

Jerusalem, Israel

Location

MeSH Terms

Conditions

Proximal Femoral Fractures

Condition Hierarchy (Ancestors)

Femoral Neck Fractures; Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Central Study Contacts

Yoram Weil

CONTACT

972-2-6776342; weily@hadassah.org.il

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 4, 2010
• First Posted: November 5, 2010
• Primary Completion: March 1, 2015
• Last Updated: March 22, 2013

Record last verified: 2013-03

Locations

IL (1)