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.
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedFirst Submitted
Initial submission to the registry
April 27, 2022
CompletedFirst Posted
Study publicly available on registry
May 6, 2022
CompletedJuly 20, 2023
July 1, 2023
3.4 years
April 27, 2022
July 18, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
change in Knee range of motion
1 month and 12 month
Postoperative complications
form first day to 12 month
Reoperation rate
form first day to 12 month
Operative time
At the operation
Study Arms (2)
Fixation
ACTIVE COMPARATORopen reduction and internal fixation by using lateral and medial plates.
Replacement
EXPERIMENTALexcision of the distal part of femur and replacement with distal femoral prosthesis
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
Eligibility Criteria
You may qualify if:
- AO 33 A3 and 33 C fractures
- Age group ≥ 60 years
- Closed fractures
- Neurovascular intact
You may not qualify if:
- Open fractures
- Non ambulant patients
- Patients with peripheral neurovascular diseases
- Peri-prosthetic fractures
- Associated other orthopedic injuries
- Poly-traumatized patients
- Pathological fractures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain Shams University - Faculty of Medicine
Cairo, 1181, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amr GM Gendya, MSc Ortho.
Ain Shams University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Lecturer , Ain Shams University.
Study Record Dates
First Submitted
April 27, 2022
First Posted
May 6, 2022
Study Start
August 20, 2018
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
July 20, 2023
Record last verified: 2023-07