DP Vs DFR for Management of Geriatric Distal Femur Fractures.

NCT ID: NCT05363943

Last Updated: 2023-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-20
• Study Completion Date: 2021-12-31

Brief Summary

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.

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.

Conditions

Distal Femur Fracture; Geriatrics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Fixation

open reduction and internal fixation by using lateral and medial plates.

Group Type: ACTIVE_COMPARATOR

double plating

Intervention Type: PROCEDURE

open reduction and internal fixation by using lateral and medial plates.

Replacement

excision of the distal part of femur and replacement with distal femoral prosthesis

Group Type: EXPERIMENTAL

Distal femoral replacement

Intervention Type: PROCEDURE

excision of the distal part of femur and replacement with distal femoral prosthesis

Interventions

double plating

open reduction and internal fixation by using lateral and medial plates.

Intervention Type: PROCEDURE

Distal femoral replacement

excision of the distal part of femur and replacement with distal femoral prosthesis

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amr Gamaleldin Mahmoud Khalil Gendya

OTHER

Sponsor Role: lead

Responsible Party

Amr Gamaleldin Mahmoud Khalil Gendya

Assistant Lecturer , Ain Shams University.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Amr GM Gendya, MSc Ortho.

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

Ain Shams University - Faculty of Medicine

Cairo, , Egypt

Countries

Egypt

Other Identifiers

FMASU MD 291/2019

Identifier Type: -

Identifier Source: org_study_id