Status:
ACTIVE_NOT_RECRUITING
Trochanteric Femur Fracture Operated With Dynamic Hip Screw System (DHS) Augmented With a Biphasic Apatite Sulphate Combined With Systemic or Local Bisphosphonate
Lead Sponsor:
Lithuanian University of Health Sciences
Collaborating Sponsors:
Lund University Hospital
Conditions:
Trochanteric Fracture of Femur
Eligibility:
All Genders
65-90 years
Phase:
NA
Brief Summary
The purpose of this study is to study the process of bone regeneration around a metal device in the femoral neck canal using a synthetic bone substitute Cerament bone void filler (BVF) and bisphosphon...
Detailed Description
Osteoporosis associated fragility fractures in the elderly are a societal and financial burden in the western world and this burden has also started to affect developing nations. With the aging of the...
Eligibility Criteria
Inclusion
- Patients 65-90 years of age;
- Fame classification with low mortality and high fracture risk.
- 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 dynamic hip screw);
- Patient with a communicative ability to understand the procedure and participate in the study and the follow-up program.
Exclusion
- Previous hip or pelvic fractures on the same side,
- Concurrent oral treatment with corticosteroids, and/or osteoporosis medication
- Irreversible coagulopathy or bleeding disorder. Note regarding reversible coagulopathies: Patients on coumadin or other anticoagulants may participate. Investigators should follow routine practices for perioperative discontinuation and re-initiation of anticoagulants;
- Concurrent dialysis or elevated creatinine
- Hypo or hyper calcaemia
- Active treatment due to malignancy including ongoing or completed radiotherapy involving the pelvis/hip area,
- 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
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04498715
Start Date
June 1 2021
End Date
December 1 2024
Last Update
February 1 2024
Active Locations (1)
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1
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas, Lithuania