Trochanteric Femur Fracture Operated With Dynamic Hip Screw System (DHS) Augmented With a Biphasi… (NCT04498715) | Clinical Trial Compass
UnknownNot Applicable
Trochanteric Femur Fracture Operated With Dynamic Hip Screw System (DHS) Augmented With a Biphasic Apatite Sulphate Combined With Systemic or Local Bisphosphonate
Lithuania20 participantsStarted 2021-06-01
Plain-language 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 bisphosphonate (Zometa) locally or systemically that affects bone metabolism. Furthermore, fracture healing and implant migration will be investigated.
Who can participate
Age range65 Years – 90 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
What they're measuring
1
Change of bone density and remodeling around the head of dynamic screw