Geriatrics Clinical Trial
Official title:
Double Plating (DP) Fixation vs Distal Femoral Replacement (DFR) in the Management of Distal Femoral Fractures in Geriatric Patients.
Verified date | July 2023 |
Source | Ain Shams University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Ain Shams University - Faculty of Medicine | Cairo |
Lead Sponsor | Collaborator |
---|---|
Amr Gamaleldin Mahmoud Khalil Gendya |
Egypt,
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 |
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