Clinical trial NCT05363943: DP Vs DFR for Management of Geriatric Distal Femur Fractures.
Official title: Double Plating (DP) Fixation vs Distal Femoral Replacement (DFR) in the Management of Distal Femoral Fractures in Geriatric Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distal Femur Fracture
Geriatrics
Keywords: Distal femoral fractures
Double plating
Distal femoral replacement
Geriatrics
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-05-06
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: change in Knee Society Score
timeFrame: 1 month, 6 month and 12 month
Secondary outcomes:
measure: change in Knee range of motion
timeFrame: 1 month and 12 month
measure: Postoperative complications
timeFrame: form first day to 12 month
measure: Reoperation rate
timeFrame: form first day to 12 month
measure: Operative time
timeFrame: At the operation
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University - Faculty of Medicine
Study officials:
affiliation: Ain Shams University
name: Amr GM Gendya, MSc Ortho.
role: PRINCIPAL_INVESTIGATOR
References: