MedTrace Logo

FEA, Biomechanical and Clinical Study of R.O. Peritrochanteric Fractures With PFLP vs Cephalomedullary Nail.

NCT05286905 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-03-18

No results posted yet for this study

Summary

Hip fractures are the second most common fracture regardless of age, while at the same time its incidence is on the rise and it is expected to keep increasing in the future. In addition, hip fractures oppose a serious problem for both patients and clinicians, as they are associated with high rates of morbidity, reduced quality of life, impeded independent functionality and higher institutionalization rates. Several osteosynthesis techniques have been proposed for surgical correction of hip fractures which can be grouped into 3 main categories: a) Dynamic Hip Screw (DHS) extramedullary systems, b) Proximal femoral nail N \[PN\] PFNA\], γ-nail \[GN\] or other implants) and (c) Dynamic Condylar Screw, Angled blade plates, Proximal Femur Locking Plate (PFLP).

This study will compare the use of anatomical proximal femur locking plates ( PeriLock, Smith\& Nephew) with an intramedullary nailing system, one of the most common and literature supported implants for the reduction of reverse oblique intertrochanteric fractures, classified as A31- 1,3 according to AO. The study will include Biomechanical testing and finite element analysis of the implants in an experimental setup using artificial bones performed at the Laboratory of Technology and Strength of Materials of the Department of Mechanical Engineering and Aeronautics of the University of Patras. and a pilot, prospective, randomized clinical study in a sample of 30 patients divided into 2 groups, where comparison of perioperative and intraoperative data will be accessed.

The purpose of this study is to evaluate the efficacy and mechanical stability as wells as the clinical and radiological parameters as well as quality-of-life indicators in patients with reverse oblique hip fractures The primary goal of to investigate whether there are statistically significant differences in the main radiological parameters (cut-out, misalignment of the femoral head, loss of alignment, defective posture, non-union), while The second primary goal is to assess the functional and general health status of patients up to 24 weeks postoperatively, using special clinical evaluation scales (Harris Hip score-HHS and Oxford hip score-OHS), as well as pain levels perioperatively

Conditions

  • Pertrochanteric Fracture of Femur, Closed

Interventions

DEVICE

Osteosynthesis cephalomedullary nail

Osteosynthesis of reverse oblique peritrochanteric fractures with cephalomedullary nail

DEVICE

Osteosynthesis proximal femur locking plate

Osteosynthesis of reverse oblique peritrochanteric fractures with proximal femur locking plate

Sponsors & Collaborators

  • University General Hospital of Patras

    lead OTHER

Principal Investigators

  • Andreas Panagopoulos, As. Prof. · University of Patras

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-22
Primary Completion
2025-10-22
Completion
2026-02-22

Countries

  • Greece

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05286905 on ClinicalTrials.gov