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DP Vs DFR for Management of Geriatric Distal Femur Fractures.

A

Amr Gamaleldin Mahmoud Khalil Gendya

Status

Completed

Conditions

Geriatrics
Distal Femur Fracture

Treatments

Procedure: double plating
Procedure: Distal femoral replacement

Study type

Interventional

Funder types

Other

Identifiers

NCT05363943
FMASU MD 291/2019

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

30 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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