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

NCT05286905 | Recruiting

• 1 other identifier: 13474
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Peritrochanteric fractures; reverse oblique; proximal femur locking plate; Cephalomedullary nail

Outcome Measures

Primary Outcomes (2)

• Radiological differences of cephalodullary nail vs PFLP

  tatistically significant differences in the main radiological parameters (cut-out, misalignment of the femoral head, loss of alignment, defective posture, non-union), in patients over 65 years of age with reverse oblique hip fractures treated with the classic intramedullary nail system versus PFLP over a .

  24-week follow-up period

• Functional status (Oxford hip score-OHS)

  Assess the functional status of patients up to 24 weeks postoperatively

  24 weeks

Secondary Outcomes (1)

• Functional status (Harris Hip score-HHS)

  24 weeks

Study Arms (2)

Patients who receive cephalomedullary nail

ACTIVE COMPARATOR

Patients who receive cephalomedullary nail

Device: Osteosynthesis cephalomedullary nail

Patients who receive proximal femur locking plate

ACTIVE COMPARATOR

Patients who receive proximal femur locking plate

Device: Osteosynthesis proximal femur locking plate

Interventions

Osteosynthesis cephalomedullary nail DEVICE

Osteosynthesis of reverse oblique peritrochanteric fractures with cephalomedullary nail

Patients who receive cephalomedullary nail

Osteosynthesis proximal femur locking plate DEVICE

Osteosynthesis of reverse oblique peritrochanteric fractures with proximal femur locking plate

Patients who receive proximal femur locking plate

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• A31-1,3 intertrochanteric fracture ( AO classification) due to trauma, closed injury.
• Patients over 65 years of age
• Presentation in the hospital within 7 days from the fracture
• There are no concomitant injuries or previous operations on the unaffected hip

You may not qualify if:

• Patients with concomitant injuries that affect the treatment and rehabilitation of the affected limb
• Patients with associated neurovascular injuries requiring immediate surgery
• Patients with limited Greek language proficiency, including family members
• Patients who refuse to sign admission consent to the study
• Patients with severe dementia, bedridden and severe comorbidities that are a contraindication to surgery

Sponsors & Collaborators

• University General Hospital of Patras: lead

Study Sites (1)

General University Hospital of Patras

Pátrai, Achaia, 26504, Greece

RECRUITING

Related Publications (34)

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Study Officials

• Andreas Panagopoulos, As. Prof.

  University of Patras

  STUDY DIRECTOR

Central Study Contacts

Nikolaos G Parchas, Md.

CONTACT

6937239368; nio8693@yahoo.gr

Andreas Panagopoulos, As. Prof.

CONTACT

2613603555; andpan21@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Md. Resident, Department of Orthopedics and Traumatiology, University General Hospital of Patras

Study Record Dates

• First Submitted: February 27, 2022
• First Posted: March 18, 2022
• Study Start: February 22, 2022
• Primary Completion: October 22, 2025
• Study Completion: February 22, 2026
• Last Updated: March 18, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After the completion of the study
• Access Criteria: Free

Locations

GR (1)