Clinical Trials Directory

Trials / Completed

CompletedNCT05363943

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.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
30 (actual)
Sponsor
Amr Gamaleldin Mahmoud Khalil Gendya · Academic / Other
Sex
All
Age
60 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDUREdouble platingopen reduction and internal fixation by using lateral and medial plates.
PROCEDUREDistal femoral replacementexcision of the distal part of femur and replacement with distal femoral prosthesis

Timeline

Start date
2018-08-20
Primary completion
2021-12-31
Completion
2021-12-31
First posted
2022-05-06
Last updated
2023-07-20

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT05363943. Inclusion in this directory is not an endorsement.