CERAMENT BONE VOID FILLER

Transcription

1 CERAMENT BONE VOID FILLER Rapid and complete bone remodeling TM

2 CERAMENT BONE VOID FILLER CERAMENT is an injectable, moldable, drillable and radiopaque bone substitute which provides rapid and complete bone remodeling within 6-12 months 1,2,3. Unique features: R Injectable, Moldable, Drillable 1,2,3 R Rapid and complete bone remodeling 1,2,3 R Highly visible under fluoroscopy 2 R Not temperature sensitive R Non-exothermic R Robust clinical data R 30 second, enclosed mix Consistent mixing and handling that is true to the time chart MIX WAIT INJECT WAIT MOLD WAIT DRILLING & SCREW INSERTION 0 30s 3 min 5 min 7 min 9 min ~15 min REFERENCES 1. Svacina. Case Reports in Orthopedics Volume 2016, Article ID Kaczmarczyk et al. BMC Musculosketelal disorders (2015) 16: Abramo et al J Biomed Mater Res Part B: Appl Biomater 92B: , Nilsson M, Zheng M H, Tägil M: Expert Rev. Med. Devices 10(5), , Nilsson M, Wang JS, et al. J. Bone Joint Surg. Brit. 86B(1), , 6. Voor MJ, Borden J, Burden RL Jr, Waddell SW. Cancellous bone defect healing with a novel calcium sulfate - hydroxyapatite composite injectable bone substitute.presented at: 56th Annual Meeting of the Orthopaedic Research Society, New Orleans,

3 How CERAMENT remodels bone UNIQUE COMPOSITION CERAMENT is composed of 40% hydroxyapatite (HA) and 60% calcium sulfate (CaS), and a radiopacity enhancing agent for visibility under fluoroscopy. IMPLANTED High flowability enables injection through narrow needles and ensures an excellent spread in the trabecular system. BIOACTIVE A layer of native HA forms on the surface of CERAMENT and retards the CaS resorption. 5 Contact with bone is enhanced because the bone cells recognize the apatite layer as natural bone mineral. 4,5 OSTEOCONDUCTIVE HA particles are delivered by the CaS and create a scaffold. After the CaS has resorbed, new bone will completely surround and embed the HA particles. 4 BONE FORMATION Early vascularization and invasion of osteoblasts enable multiple site formation of bone throughout the cured CERAMENT. 6 40% Hydroxyapatite (HA) Proprietary Composition CERAMENT consists of 40% hydroxyapatite (HA) and 60% calcium sulfate (CaS). The addition of a liquid radiopacity enhancing agent provides for an injectable paste which is radiographically visible. 60% Calcium Sulfate (CaS) The CaS works as a delivery tool for the osteoconductive HA

4 Proven Results More than 9 years of clinical evidence, more than 40 pre-clinical and clinical studies and four year patient follow-up data, demonstrate the safety, efficacy and long-term bone remodeling capabilities of CERAMENT. Case 1: Trauma Bicondylar Osteoporotic Tibial Plateau Fracture A female (88 years old) underwent open reduction and internal fixation of angulated, impacted, displaced and unstable left tibial plateau bicondylar fracture, with percutaneous lateral plate application. CERAMENT BONE VOID FILLER was injected to fill resulting void after fracture reduction. Fig A & B. At 18 months patient was clinically improved and ambulating well. Radiographs showed remodeling of CERAMENT BONE VOID FILLER into new bone. Fig C & D. Figure A. Intra operative anterior-posterior radiograph placement of CERAMENT BONE VOID FILLER Figure B. Intra operative lateral radiograph placement of CERAMENT BONE VOID FILLER Figure C. At 18 months anteriorposterior radiograph demonstrating excellent incorporation of CERAMENT BONE VOID FILLER into new bone. Figure D. At 18 months lateral radiograph demonstrating excellent incorporation of CERAMENT BONE VOID FILLER into new bone. Credit: Dr. Prashant Desai, D.O. Lakeland Regional Medical Center, Lakeland, Florida, USA

5 Case 2 : Reconstructive Orthopedics Hip Revision A 61-year old male with a history of well- positioned, well functioning bilateral uncemented THAs presented with progressive left hip pain over 6 months. X-rays showed a large cystic osteolytic lesion in the left acetabulum involving the superior dome and the medial wall with extension into the ischium. CT scan confirmed extensive amount of osteolysis. Intraoperatively, significant wear of the polythylene liner allowing subluxation of the femoral head was found. The cup was solidly fixed and was not revised. The femoral head was exchanged for a new 32 mm head and the liner was exchanged to a10-degree elevated lip liner. Figure 1. Figure 2. Figure 3. Figure 4. A 2x2cm window was made above the acetabulum at the level of the cyst. The cyst was curetted and filled with 32cc CERAMENT BONE VOID FILLER (Fig. 1). Once CERAMENT had set, the wound was irrigated and closed. Figure 5. At 6 weeks post-op, the patient had good and painless range of motion and was weight-bearing without aides. X-rays confirmed good positioning of the acetabular implant CERAMENT is still visible (Fig. 2). At 11 weeks post-op, CE- RAMENT is no longer visible (Fig. 3). At 8 months post-op, the patient was doing well and was pain-free. X-rays demonstrated CERAMENT to be nearly completely resorbed and replaced with new cancellous bone (Figs. 4 & 5). Credit: Thomas Baier, M.D. Advocate Condell Medical Center, Libertyville, IL USA

6 Case 3 : Foot and Ankle Treatment of displaced intra-articular calcaneal fracture A female (54 years old) with a displaced intra-articular calcaneal fracture had open reduction and internal fixation (ORIF) (Fig. A). The resulting bone void after fracture reducation was filled with CERAMENT BONE VOID FILLER. Figure A. X-ray immediately post surgery. Removal of the plate at 5 months due to pain (no signs of infection) facilitated a bone biopsy which showed early signs of new bone growth where CERAMENT was implanted (Fig B). At 7 months the patient demonstrates a good result and is fully weight-bearing. (Fig. C). Figure B. Histology at 5 months showing new bone growth. Figure C. X-ray after removal of the plate and is fully weight-bearing. Credit: Damiano Papadia Reparto di Ortopedia e, Traumatologia Ospedale, Santa Chiara, Trento, Italy

7 Figure 1. Figure 2. Case 4 : Ortho-Oncology Minimally Invasive Treatment of a Benign Proximal Humeral Cyst Large unicameral bone cyst (UBC) of the proximal humerus with thinning of proximal cortices (Fig. 1). The cyst was aspirated using a large-bore needle then exchanged for a cannula for pressure relief during injection of CERAMENT BONE VOID FILLER (Fig. 2, 3). Figure 3. Figure4. An additional cannula was placed into the distal part of the cyst. The CERAMENT BONE VOID FILLER delivery syringe was attached to the end of the distal cannula and injected one minute after mixing to ensure complete filling of the void via a bottom-to-top (distal to proximal) technique. Figure 5. Figure 6. 30cc of CERAMENT BONE VOID FILLER was injected. Iohexol provides visibility of product under fluoroscopy (Fig. 3) and the postoperative radiograph (Fig. 4). R R 6 week X-ray demonstrates a white halo effect outlining the cyst (Fig. 5). At 3 months, early bone remodeling is seen, along with a puddling effect at bottom of cyst (Fig. 6). R R 5 month X-ray shows on-going replacement of CERAMENT BONE VOID FILLER with new cancellous bone (Fig. 7). Figure 7. Credit: Joseph Benevenia, M.D. Rutgers University Hospital, Newark, NJ

8 REFERENCE IMAGES REPRODUCED BY KIND PERMISSION OF: 1. Dr P Desai, Lakeland Regional medical Center, Lakeland Florida USA 2. Dr L DiDomenico, Adjunct Professor, Ohio College of Podiatric Medicine, Youngstown, Ohio, USA 3. Dr J Svacina, Bodden-Kliniken Ribnitz-Damgarten, Germany THE PROBLEM TRAUMA Pre-operative ap radiograph of tibial plateau fracture 1 BONE CYST Pre-operative lateral radiograph of calcaneal bone cyst 2 RECONSTRUCTIVE ORTHOPEDICS Pre-operative acetabular fracture THE SOLUTION TRAUMA Intra-operative ap radiograph showing placement of CERAMENT BONE VOID FILLER 1 At 18 months ap radiograph demonstrating excellent incorporation of CERAMENT BONE VOID FILLER by new bone 1 BONE CYST Intra-operative percutaneous replacement of bone void with CERAMENT BONE VOID FILLER 2 24-month post-operative lateral radiograph demonstrating complete incorporation by bone 2 RECONSTRUCTIVE ORTHOPEDICS At 12 months - bone remodeling and hip mobility observed radiographically 3 Acetabular revision surgery utilizing CERAMENT BONE VOID FILLER 3 Ordering Information Restoring health to improve the quality of life for patients with bone disorders. TM Product BONESUPPORT Codes (effective 10/21/18) Zimmer Biomet Codes (good through 5/20/19) CERAMENT BONE VOID FILLER 5 ml A CERAMENT BONE VOID FILLER 10 ml A CERAMENT BONE VOID FILLER 18 ml A BONESUPPORT, INC., 60 William St, Suite 330, Wellesley, MA T: To order us.sales@bonesupport.com PR en US