DP Vs DFR for Management of Geriatric Distal Femur Fractures.

Geriatrics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05363943
• Other study ID #: FMASU MD 291/2019
• Status: Completed
• Phase: N/A
• Start date: August 20, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Distal Femur Fracture
• Femoral Fractures
• Fractures, Bone
• Geriatrics

Intervention

Procedure:
• double plating
open reduction and internal fixation by using lateral and medial plates.
• Distal femoral replacement
excision of the distal part of femur and replacement with distal femoral prosthesis

Locations

Country	Name	City	State
Egypt	Ain Shams University - Faculty of Medicine	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Amr Gamaleldin Mahmoud Khalil Gendya

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Postoperative complications	Assessment of postoperative complications either early or late complications	form first day to 12 month
Secondary	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
Secondary	Operative time	Recording of the operative time from the time of incision to the time of skin closure	At the operation