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

NCT06135298 | Completed Phase 4 DMC

• 1 other identifier: 2023/1702
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Trochanteric Fracture of Femur; Osteoporotic Fracture of Femur; Hip Fractures; Bone Density, Low

Keywords

Proximal femoral nail (PFN); Biphasic apatite sulphate ceramic; Zoledronic acid; Augmentation; Bone regeneration

Outcome Measures

Primary Outcomes (2)

• Change of bone density around the helical blade of proximal femoral nail

  Change of bone density measured by Dual-energy X-ray absorptiometry (DEXA) scan of bilateral proximal femurs will be evaluated. A 10 % increase in bone density / bone volume in the femoral head adjacent to the helical blade is expected to be significant and clinically relevant.

  1-week and 6 months after the surgery

• Bone remodeling around the helical blade of proximal femoral nail

  Bone remodeling around the helical blade will be evaluated by computerized tomography (CT) scan of the pelvis using a program for alleviating metal artefacts. A 10 % increase in bone density / bone volume in the femoral head adjacent to the helical blade is expected to be significant and clinically relevant.

  1-week and 6 months after the surgery

Secondary Outcomes (4)

• Harris Hip Score

  1-week and 6 months after the surgery

• Screw position and migration by X-ray

  1-week and 6 months after the surgery

• Evaluation of fracture union

  6 months after the surgery

• Any mechanical complications

  6 months after the surgery

Study Arms (2)

OSTEOSYNTHESIS + SYSTEMIC ZOLEDRONIC ACID

ACTIVE COMPARATOR

After osteosynthesis, systemic Zoledronic acid 5mg will be given intravenously at day 5 after surgery, during hospitalization.

Procedure: OSTEOSYNTHESIS; Drug: Zoledronic acid

OSTEOSYNTHESIS + LOCAL CERAMENT BONE VOID FILLER (BVF) + SYSTEMIC ZOLEDRONIC ACID

EXPERIMENTAL

During osteosynthesis, cerament BVF will be used for the augmentation of the helical blade. Then, systemic Zoledronic acid 5mg will be given intravenously at day 5 after surgery, during hospitalization.

Procedure: OSTEOSYNTHESIS; Drug: Zoledronic acid; Device: CERAMENT BONE VOID FILLER (BVF)

Interventions

Zoledronic acid DRUG

Zoledronic acid (ZA), is a bisphosphonate, and has been shown to reduce the risk of hip fracture by 41% in post-menopausal women. For systemic injection, 5 mg (as per clinical protocol) will be injected intravenously 5 days after surgery, during hospitalization.

Also known as: Ronidro 5mg/Bag 100 mL Inj

OSTEOSYNTHESIS + LOCAL CERAMENT BONE VOID FILLER (BVF) + SYSTEMIC ZOLEDRONIC ACID; OSTEOSYNTHESIS + SYSTEMIC ZOLEDRONIC ACID

CERAMENT BONE VOID FILLER (BVF) DEVICE

In addition to the standard surgical procedure, in the study group, after creating the canal with 10 mm drill bit and partly insertion of the helical blade, the synthetic bone void filler CaS/HA will be injected. The helical blade will be inserted partially with gentle blows with a hammer, 2.5 cm from its final intended position. The injectable CaS/HA biomaterial will be mixed as per the manufacturer guidelines and the paste will be transferred into an injection syringe. At t = 2.5 min from the start of mixing, 2-3 mL of BVF paste will be injected by a CE marked Introducer Needle connected to the injection syringe, through the hollow helical blade. Finally, the helical blade will be inserted to its end position with gentle blows with a hammer. Remaining material approximately 2 mL still being moldable will be manually deposited in the trochanteric fracture void.

Also known as: CaS/HA

OSTEOSYNTHESIS + LOCAL CERAMENT BONE VOID FILLER (BVF) + SYSTEMIC ZOLEDRONIC ACID

OSTEOSYNTHESIS PROCEDURE

Routine procedure for anesthesia and infection prophylaxis according to written instructions will be followed in every patient. The patient will be operated supine with the fractured leg positioned in traction table. The hip region is scrubbed and dressed in sterile drapes. Using standard technique, a nail is inserted into the intramedullary canal after fracture reduction. To insert the helical blade in the femoral neck, 2.0 mm diameter guide wire is first placed in the femoral neck, checking the fluoroscopic AP and lateral views. The canal is opened using a 10 mm drill bit and the length of helical blade is measured. After the pilot hole is created for the helical blade placement, the hollow helical blade will be inserted to its end position with gentle blows with a hammer.

Also known as: Proximal femoral nail with helical blade

OSTEOSYNTHESIS + LOCAL CERAMENT BONE VOID FILLER (BVF) + SYSTEMIC ZOLEDRONIC ACID; OSTEOSYNTHESIS + SYSTEMIC ZOLEDRONIC ACID

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aksaray University: lead
• Lund University Hospital: collaborator

Study Sites (1)

Aksaray University Training and Research Hospital

Aksaray, Aksaray, 68200, Turkey (Türkiye)

Location

Related Publications (3)

• Black DM, Delmas PD, Eastell R, Reid IR, Boonen S, Cauley JA, Cosman F, Lakatos P, Leung PC, Man Z, Mautalen C, Mesenbrink P, Hu H, Caminis J, Tong K, Rosario-Jansen T, Krasnow J, Hue TF, Sellmeyer D, Eriksen EF, Cummings SR; HORIZON Pivotal Fracture Trial. Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. N Engl J Med. 2007 May 3;356(18):1809-22. doi: 10.1056/NEJMoa067312.

  PMID: 17476007 BACKGROUND

• Raina DB, Markeviciute V, Stravinskas M, Kok J, Jacobson I, Liu Y, Sezgin EA, Isaksson H, Zwingenberger S, Tagil M, Tarasevicius S, Lidgren L. A New Augmentation Method for Improved Screw Fixation in Fragile Bone. Front Bioeng Biotechnol. 2022 Mar 2;10:816250. doi: 10.3389/fbioe.2022.816250. eCollection 2022.

  PMID: 35309986 RESULT

• Sezgin EA, Tor AT, Markeviciute V, Sirka A, Tarasevicius S, Raina DB, Liu Y, Isaksson H, Tagil M, Lidgren L. A combined fracture and mortality risk index useful for treatment stratification in hip fragility fractures. Jt Dis Relat Surg. 2021;32(3):583-589. doi: 10.52312/jdrs.2021.382. Epub 2021 Nov 19.

  PMID: 34842088 RESULT

MeSH Terms

Conditions

Hip Fractures; Bone Diseases, Metabolic

Interventions

Fracture Fixation, Internal; Zoledronic Acid

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative; Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Erdem Aras Sezgin, MD

  Aksaray University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Patients in the study group and the control group will be blind to the group they are assigned to until the end of the trial. As intervention is performed during the surgery, blinding will not be possible for the surgical team. Investigators will be blinded during all evaluations, however due to radio-opaque nature of CERAMENT™ BVF, detection of intervention group is possible in CT, DEXA and X-ray evaluations.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A total of 20 eligible patients with osteoporotic per trochanteric fractures, that are scheduled to be treated with proximal femoral nail (PFN), will be included in the study after informed and approved consent and will be randomized into two groups. Randomization will be performed by the principal investigator, by sealed envelopes, after determining if the patient fulfills the inclusion criteria.

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 18, 2023
• Study Start: December 1, 2023
• Primary Completion: July 1, 2025
• Study Completion: January 15, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)