DP Vs DFR for Management of Geriatric Distal Femur Fractures.

Not Applicable

Completed

• Conditions: Geriatrics; Distal Femur Fracture
• Interventions: Procedure: double plating; Procedure: Distal femoral replacement

• Registration Number: NCT05363943
• Lead Sponsor: Amr Gamaleldin Mahmoud Khalil Gendya

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.

Study Timeline

• Study Start: 2018-08-20
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Study First Submitted: 2022-04-27
• Study First Submitted QC: 2022-05-03
• Study First Posted: 2022-05-06
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-18
• Last Update Posted: 2023-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fixation	double plating	open reduction and internal fixation by using lateral and medial plates.
Replacement	Distal femoral replacement	excision of the distal part of femur and replacement with distal femoral prosthesis

Primary Outcome Measures

Name	Time	Method
change in Knee Society Score	1 month, 6 month and 12 month	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.

Secondary Outcome Measures

Name	Time	Method
Postoperative complications	form first day to 12 month	Assessment of postoperative complications either early or late complications
Operative time	At the operation	Recording of the operative time from the time of incision to the time of skin closure
Reoperation rate	form first day to 12 month	Recording the need for secondary operation for a cause related to the fracture union, postoperative complications, or prothesis problems.
change in Knee range of motion	1 month and 12 month	Assessment of range of motion of the knee which has normal range from 0 to 135

Trial Locations

Locations (1)

Ain Shams University - Faculty of Medicine; 🇪🇬 Cairo, Egypt