PRO-DENSE^™

How PRO-DENSE^™ Works

Tri-Phasic Resorption Results in an Injectable, Self-forming, Porous Scaffold In Vitro Accelerated Dissolution at 37°C in H2O (Samples embedded and cross-sectioned for analysis via SEM)

(Approximately six times faster than in vivo canine model)

TIME: 0 Days

Injectable graft sets up with a compressive strength of 40MPa (at 2 hours, wet conditions)

TIME: 4 Days
in an accelerated model
(approx. 24 days in vivo)

Calcium sulfate (CaSO4) is resorbed primarily through simple dissolution in the 1st phase. The brushite and tricalcium phosphate (TCP) components remain forming an interconnected, porous scaffold

TIME: 8 Days
in an accelerated model
(approx. 24 days in vivo)

Continued dissolution of the primary 1st phase. In vivo, the body will have begun osteoclastic resorption of the brushite (2nd phase) and TCP (3rd and final phase).

TIME: 12 Days
in an accelerated model
(approx. 77 days in vivo)

Further dissolution of the CaSO4 and calcium phosphate (CaPO4). During these later phases the body will lay down dense new bone on and throughout the porous scaffold

CaSO4 fully resorbed: The final phases of graft resorption will remove the remaining calcium phosphate. The body will remodel the regenerated bone to a more normal state over time.

TIME: 0 Days

Injectable graft sets up with a compressive strength of 40MPa (at 2 hours, wet conditions)

---

TIME: 4 Days
in an accelerated model
(approx. 24 days in vivo)

Calcium sulfate (CaSO4) is resorbed primarily through simple dissolution in the 1st phase. The brushite and tricalcium phosphate (TCP) components remain forming an interconnected, porous scaffold

---

TIME: 8 Days
in an accelerated model
(approx. 24 days in vivo)

Continued dissolution of the primary 1st phase. In vivo, the body will have begun osteoclastic resorption of the brushite (2nd phase) and TCP (3rd and final phase).

---

TIME: 12 Days
in an accelerated model
(approx. 77 days in vivo)

Further dissolution of the CaSO4 and calcium phosphate (CaPO4). During these later phases the body will lay down dense new bone on and throughout the porous scaffold*

CaSO4 fully resorbed: The final phases of graft resorption will remove the remaining calcium phosphate. The body will remodel the regenerated bone to a more normal state over time.

*Data on file at Wright*

Mechanism of Action

PRO-DENSE^™ Graft has a triphasic resorption profile that provides an ideal environment​ for the direct deposition of bone resulting in a slow-resorbing matrix that supports healing across the defect.​†

The following illustrations describe the basic steps in the process of new bone formation.

1. Angiogenesis is a key early event. The CaSO4 of the implant resorbs first, revealing a porous calcium phosphate scaffold conducive to vascular infiltration.

2. The resulting brushite/TCP scaffold with interconnecting pores binds free proteins such as VEGF and BMP-2 at the implant/defect interface.†

3. Resorption of the PRO-DENSE^™ scaffold releases bound proteins. Active proteins recruit cells to the implant surface.†

4. Growth factors in the implant/defect interface region, including BMPs, stimulate proliferation and differentiation of mesenchymal stem cells.

5. Differentiated osteoblasts lay down osteoid which then mineralizes to become newly woven bone.

6. The principles of Wolff’s Law drive remodeling

​​†Growth factor binding based on in vitro data of BMP-2 and VEGF. Data on file.

Pre-Clinical Findings

Pre-clinical findings demonstrate that PRO-DENSE™ Bone Graft is stronger, faster, and more dense bone vs. Autograft.*

STRONGER NEW BONE*

Mechanical properties at 13 and 26 weeks: At 13 weeks, PRO-DENSE^™ regenerates new bone with compressive strength that is almost six times vs. autograft, well over ten times vs. allograft CBM, and over three times greater than normal, unoperated bone. The 26 week mechanical results also demonstrate that this quality new bone is remodeling to a more normal state.*

*All claims are based on a critically sized canine proximal humerus defect model. It is unknown how results from the canine model compare with clinical results in humans. Data on file at Wright.

FASTER, DENSER BONE REGENERATION*

Histology at 13 weeks: The PRO-DENSE^™ specimen (middle) demonstrated consistently denser and thicker trabeculae vs. autograft (left) and Cancellous Bone Matrix (right) at the same time point. Basic Fuchsin and Toluidine Blue, 75x.

Bibliography

• Sionek A, et. al. Hip Osteonecroses Treated with Calcium Sulfate-Calcium Phosphate Bone Graft Substitute Have Different Results According to the Cause of Osteonecrosis: Alcohol Abuse or Corticosteroid-Induced. International Orthopaedics (2018) 42:1491–1498. Read More
• Landgraeber S, et al. Modifications to Advanced Core Decompression for Treatment of Avascular Necrosis of the Femoral Head. BMC Musculoskelet Disord. 2017 Nov 21;18(1):479. Read More
• Civinini R, et al. The Kinetics of Remodeling of a Calcium Sulfate/Calcium Phosphate Bioceramic. J Mater Sci Mater Med. 2017 Sep;28(9):137. Read More
• Fillingham Y, et al. Bioceramic Bone Graft Substitute for Treatment of Unicameral Bone Cysts. Journal of Orthopaedic Surgery 2016;24(2):222-7. Read More
• Tan V, et al. Chronology of the Radiographic Appearances of the Calcium Sulfate-Calcium Phosphate Synthetic Bone Graft Composite Following Resection of Bone Tumors: A follow-up Study of Postoperative Appearances. Can Assoc Radiol J. 2016 Feb;67(1):21-7. Read More
• Formby P, et al. Treatment of Symptomatic Intraosseous Pneumatocyst using Intraoperative Navigation. Slack Incorporated. March 2015: e244-e247. Read More
• Gentile JV, et al. Treatment of Unicameral Bone Cysts in Pediatric Patients with an Injectable Regenerative Graft: A Preliminary Report. J Pediatr Orthop. 2013;33:254-61 Read More
• Evaniew N, et al. Use of a Calcium Sulfate-Calcium Phosphate Synthetic Bone Graft Composite in the Surgical Management of Primary Bone Tumors. Orthopedics. 2013;36(2):e216-e222. Read More
• Fillingham YA, et al. Function after Injection of Benign Bone Lesions with a Bioceramic. Clin Orthop Relat Res. 2012;470(7): 2014-20. Read More
• Civinini R, et al. The Use of an Injectable Calcium Sulphate/Calcium Phosphate Bioceramic in the Treatment of Osteonecrosis of the Femoral Head. Int Orthop. 2012;36(8):1583-8. Read More
• Landgraeber S, et al. Advanced Core Decompression, a New Treatment Option of Avascular Necrosis of the Femoral Head – A First Follow-up. J Tissue Eng Regen Med. 2012 Apr 4. doi: 10.1002/term.1481 Read More
• Kotnis NA, et al. Chronology of the Radiographic Appearances of the Calcium Sulphate-Calcium Phosphate Synthetic Bone Graft Composite Following Resection of Bone Tumours-A Preliminary Study of the Normal Post-operative Appearances. Skeletal Radiol. 2010 Oct 1. Read More
• Bohner M. Design of Ceramic-Based Cements and Putties for Bone Graft Substitution. Eur Cell Mater. 2010 Jul 1;20:1-12. Read More
• Gitelis S, et al. Outcomes in the Treatment of Benign Bone Lesions Using an Engineered Bioceramic: Preclinical and Clinical Results. RUSH Orthopedics Journal. 2009;(1):37-44. Read More
• Engh CA Jr, et al. The Quality of Osteolysis Grafting with Cementless Acetabular Component Retention. Clin Orthop Relat Res. 2007;(465):150-154. Read More
• Hungerford, DS. The Use of an Injectable Calcium Sulfate / Calcium Phosphate Composite in the Treatment of Osteonecrosis of the Femoral Head. J Bone Joint Surg Br 2007; 91-B:SUPP II, Paper 331. Read More
• Urban RM, et al. Increased Bone Formation Using a Calcium Sulfate and Calcium Phosphate Composite Graft. Clin Orthop Relat Res. 2007; 459:110-117. Read More

Ordering Information

Large Volume

Disposable Instrumentation

Reusable Instrumentation

PRO-DENSE™ Classic Mix