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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05363943
Enrollment
30
Registered
2022-05-06
Start date
2018-08-20
Completion date
2021-12-31
Last updated
2023-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Distal Femur Fracture, Geriatrics

Keywords

Distal femoral fractures, Double plating, Distal femoral replacement, Geriatrics

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.

Interventions

open reduction and internal fixation by using lateral and medial plates.

excision of the distal part of femur and replacement with distal femoral prosthesis

Sponsors

Amr Gamaleldin Mahmoud Khalil Gendya
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
change in Knee Society Score1 month, 6 month and 12 monththe 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

MeasureTime frameDescription
change in Knee range of motion1 month and 12 monthAssessment of range of motion of the knee which has normal range from 0 to 135
Postoperative complicationsform first day to 12 monthAssessment of postoperative complications either early or late complications
Reoperation rateform first day to 12 monthRecording the need for secondary operation for a cause related to the fracture union, postoperative complications, or prothesis problems.
Operative timeAt the operationRecording of the operative time from the time of incision to the time of skin closure

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026