Trochanteric Femur Fracture Operated With Dynamic Hip Screw System (DHS) Augmented With a Biphasic Apatite Sulphate Combined With Systemic or Local Bisphosphonate

• Status: Recruiting
• Trial end date: 2021-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lithuanian University of Health Sciences
• Collaborator: Lund University Hospital
• Treatments: Zoledronic Acid

Criteria

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