DP Vs DFR for Management of Geriatric Distal Femur Fractures.

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Distal Femur Fracture, Geriatrics

Intervention / Treatment
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* Procedure: double plating
* Procedure: Distal femoral replacement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Distal femoral fractures, Double plating, Distal femoral replacement, Geriatrics