Status:
ACTIVE_NOT_RECRUITING
FARE Augmentation of Proximal Femoral Fractures with CaS/HA and Systemic ZA
Lead Sponsor:
Aksaray University
Collaborating Sponsors:
Lund University Hospital
Conditions:
Trochanteric Fracture of Femur
Osteoporotic Fracture of Femur
Eligibility:
All Genders
65-90 years
Phase:
PHASE4
Brief Summary
The goal of this clinical trial is to investigate the new bone formation around a metal device in the femoral head in patients with osteoporotic hip fractures undergoing surgical treatment with nails....
Detailed Description
A total of 20 eligible patients with osteoporotic per trochanteric fractures, that are treated with proximal femoral nail (PFN), will be included in the study after informed and approved consent and w...
Eligibility Criteria
Inclusion
- Being between 65-90 years of age at the time of fracture
- Acute, unilateral proximal hip fracture (AO Foundation/Orthopaedic Trauma Association \[AO/OTA\]: A1 and A2) caused by low energy trauma
- Physical condition eligible for surgery with proximal femoral nail
- Having low mortality and high fracture risk according to Fracture and Mortality Risk Evaluation Index (FAME) classification
- Patient with communicative ability to understand the procedure and participate in the study and the follow-up program, consented to be included in the study and signed the consent form
Exclusion
- Previous hip or pelvis fracture on the same side
- Concurrent corticosteroid treatment
- Concurrent medical osteoporosis treatment
- Irreversible coagulopathy or bleeding disorder.
- o Note regarding reversible coagulopathies: Patients on coumadin or other anticoagulants may participate. Investigators will follow routine practices for perioperative discontinuation and re-initiation of anti-coagulants.
- Concurrent dialysis or elevated creatinine
- Presence of hypo- or hyper calcaemia
- History or active treatment due to malignancy involving the pelvis/hip area, including ongoing or completed radiotherapy
- Fractures involving acetabulum
- Active systemic infection or local skin infection at the incision site
- Known hyperthyroidism or thyroid adenoma,
- History of serious reaction to iodine-based radio contrast agents
- Patient without communicative ability to understand the procedure and participate in the study and the follow-up program, did not consent to be included in the study and/or did not sign the consent form
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06135298
Start Date
December 1 2023
End Date
December 1 2025
Last Update
February 5 2025
Active Locations (1)
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1
Aksaray University Training and Research Hospital
Aksaray, Aksaray, Turkey (Türkiye), 68200