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

Status
UNKNOWN
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01235169
Enrollment
Unknown
Registered
2010-11-05
Start date
Unknown
Completion date
Unknown
Last updated
2013-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Proximal Femur Fracture

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. Insertion an intramedullary nail (without augmentation) to the bone. 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. This new approach enables the nail a better grip as a result of the cement augmentation which consists of PMMA (Polymethyl methacrylate). The investigators main goal is to evaluate the use of this surgical technique

Interventions

DEVICEProximal Femoral Nail Antirotation(PFNA) with cement augmentation

Sponsors

Hadassah Medical Organization
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
60 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of patients reaching union at the 3-month and 6-month follow upProportion 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).

Countries

Israel

Contacts

Primary ContactYoram Weil
weily@hadassah.org.il972-2-6776342

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026