DP Vs DFR for Management of Geriatric Distal Femur Fractures.

Double Plating (DP) Fixation vs Distal Femoral Replacement (DFR) in the Management of Distal Femoral Fractures in Geriatric Patients.

The aim of this study was to compare the functional and radiological outcomes of fixation by using double plating technique versus replacement using distal femur tumor prothesis as a primary management for the distal femoral fractures in geriatric patients. The hypothesis was that the distal femoral replacement will yield better functional outcome and earlier rehabilitation and return to pre-injury level of activity.

Study Overview

• Status: Completed
• Conditions: Geriatrics; Distal Femur Fracture
• Intervention / Treatment: Procedure: double plating; Procedure: Distal femoral replacement

Detailed Description

Geriatric distal femoral fractures represent a major challenge for the orthopedic surgeons, to the present days still there is no definite algorithm or specific guidelines that can be used accurately in the management of these fractures. Unlike hip fractures however, there is no widely accepted treatment algorithm or standard of care.

The surgical treatment of distal femoral fractures depends on both patient and fracture characteristics. Options include conservative treatment, open reduction internal fixation, intramedullary nails, or recently distal femoral replacement.

There is currently a move towards distal femoral replacement (DFR) for these complex fractures which has the potential benefit of allowing early weight bearing, and therefore aiming to prevent complications associated with immobility and non-union.

Using distal femoral replacement had yield good results in small case series, as it allows immediate full weightbearing, eliminate the risk of nonunion and may provide greater satisfaction scores. However, DFR has its own risks, most notably deep infection, and loosening. While a DFR is more costly compared with fixation plates and nails, the initial increased cost may be outweighed by faster rehabilitation and return to the patient's usual place of residence.

In the study, the investigators are aiming to compare the functional and radiological outcomes of fixation by using double plating technique versus replacement as a primary management for the geriatric distal femoral fractures.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 1181
    • Ain Shams university - Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 58 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• AO 33 A3 and 33 C fractures
• Age group ≥ 60 years
• Closed fractures
• Neurovascular intact

Exclusion Criteria:

• Open fractures
• Non ambulant patients
• Patients with peripheral neurovascular diseases
• Peri-prosthetic fractures
• Associated other orthopedic injuries
• Poly-traumatized patients
• Pathological fractures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fixation; open reduction and internal fixation by using lateral and medial plates.	Procedure: double plating; open reduction and internal fixation by using lateral and medial plates.
Experimental: Replacement; excision of the distal part of femur and replacement with distal femoral prosthesis	Procedure: Distal femoral replacement; excision of the distal part of femur and replacement with distal femoral prosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in Knee Society Score	the score has two-part, knee and function parts. The score is graded from 0 to 100 in each domain with 100 is the best outcome and 0 is the worst. The knee part assesses the range of motion, pain, and alignment of the joint while the function part assesses walking, stairs and usage of walking aids.	1 month, 6 month and 12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in Knee range of motion	Assessment of range of motion of the knee which has normal range from 0 to 135	1 month and 12 month
Postoperative complications	Assessment of postoperative complications either early or late complications	form first day to 12 month
Reoperation rate	Recording the need for secondary operation for a cause related to the fracture union, postoperative complications, or prothesis problems.	form first day to 12 month
Operative time	Recording of the operative time from the time of incision to the time of skin closure	At the operation

Collaborators and Investigators

• Sponsor: Amr Gamaleldin Mahmoud Khalil Gendya
• Investigators: Principal Investigator: Amr GM Gendya, MSc Ortho., ain shams University

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2018
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: April 27, 2022
• First Submitted That Met QC Criteria: May 3, 2022
• First Posted (Actual): May 6, 2022

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Geriatrics; Distal femoral fractures; Double plating; Distal femoral replacement
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Fractures, Bone; Femoral Fractures, Distal
• Other Study ID Numbers: FMASU MD 291/2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No