FARE Augmentation of Proximal Femoral Fractures With CaS/HA and Systemic ZA

• Status: Recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

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. These surgeries have a high risk of fixation failure in patients with osteoporosis due to low bone quality. The main question we aim to answer are whether promoting new bone formation around the implant is possible with a bone graft substitute (CERAMENT™ Bone Void Filler) and systemic osteoporosis drug (zoledronic acid) combination, which can strengthen the surgical fixation of the fracture. Participants will consist of patients suffering hip fracture and already scheduled for surgical treatment with a nail. One group will undergo conventional surgery. While the other group will also undergo the same surgery, they will receive CERAMENT™ Bone Void Filler around the implant as a short, extra step during surgery. This will allow the researchers to see whether new bone is formed during a 6-month follow-up.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aksaray University
• Collaborator: Lund University Hospital
• Treatments: Zoledronic Acid

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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