PRO-DENSE

BONE GRAFT SUBSTITUTE

Key Benefits

Predictable Bone Regeneration

    • Stronger New Bone*
    • Faster, Denser Bone Regeneration*
    • Remodel to Normal Bone*

*All claims 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.

PRO-DENSE™ Injectable Regenerative Graft - Mechanism of Action Animation (US)
AP-010653

PRO-DENSE Graft is a synthetic biomaterial. Combining calcium sulfate with calcium phosphate, has result​ed in a composite graft that is delivering where other materials may fall short.
​​
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.​†

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

Faster than Autograft*
The accelerated rate of healing of the PRO-DENSE graft treated defects compared to those treated with autograft is principally evident by the higher density bone (i.e., 170% average increase in area fraction of new bone compared to autograft at 13 weeks) and superior average mechanical properties at 13 weeks.

Denser than Autograft*
Histomorphometry reveals that the amount of newly regenerated bone of the PRO-DENSE injectable graft treated defects at 13 weeks demonstrated a statistically significant 170% average increase in new bone formation versus defects treated with autograft. PRO-DENSE injectable graft new bone area fraction is on average 170% denser than autograft at 13 weeks.

Stronger than Autograft*
The newly regenerated bone in the PRO-DENSE injectable graft treated defects exhibited a 645% average increase in compressive strength at 13 weeks versus defects treated with autograft.

Intra-operative strength
Approximately 40MPa initial compressive strength (at 2 hours, wet conditions)* Reliable/consistent resorption 50% slower than pure calcium sulfate

*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.

Composite Makeup

75% CaSO4

  • Primary osteoconductive filler
  • Resorbs first primarily through simple dissolution to allow early vascular infiltration
25% CaPO4 (brushite and granular TCP)

  • Osteoclastic resorption
  • Secondary porous scaffold that is resorbed after primary filler
  • TCP granules are resorbed in the third and final phase

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)

*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.

*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.STRONGER THAN NORMAL BONE*: At 13 weeks; Urban, et al… CORR, June 2007.

FASTER THAN AUTOGRAFT*: The accelerated rate of healing of the PRO-DENSE graft treated defects compared to those treated with autograft is principally evident by the higher density bone (i.e., 170% average increase in area fraction of new bone compared to autograft at 13 weeks) and superior average mechanical properties at 13 weeks.

DENSER THAN AUTOGRAFT*: Histomorphometry reveals that the amount of newly regenerated bone of the PRO-DENSE injectable graft treated defects at 13 weeks demonstrated a statistically significant 170% average increase in new bone formation versus defects treated with autograft. PRO-DENSE injectable graft new bone area fraction is on average 170% denser than autograft at 13 weeks.

STRONGER THAN AUTOGRAFT*: The newly regenerated bone in the PRO-DENSE injectable graft treated defects exhibited a 645% average increase in compressive strength at 13 weeks versus defects treated with autograft.

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


87SR-0020 PRO-DENSE™ Injectable Regenerative Graft 2cc
87SR-0050 PRO-DENSE™ Injectable Regenerative Graft 5cc
87SR-0070 PRO-DENSE™ Injectable Regenerative Graft 7cc
87SR-0100 PRO-DENSE™ Injectable Regenerative Graft 10cc
87SR-0120 PRO-DENSE™ Injectable Regenerative Graft 12cc
87SR-0150 PRO-DENSE™ Injectable Regenerative Graft 15cc
87SR-CDK0 PRO-DENSE™ Core Decompression Kit – 15cc

 

Large Volume

87SR-0400 PRO-DENSE™ Injectable Regenerative Graft 40cc

 

Disposable Instrumentation

1200-SYR0 Syringe Only Kit
PSCL-0000 Extremity Procedure Kit with Targeting Guide
84LK-0000 Osteolysis Procedure Kit
20BL-1200 X- REAM™ Blade

 

Reusable Instrumentation

1000-KIT2 X-REAM™ Percutaneous Expandable Reamer

 

PRO-DENSE™ Classic Mix

87SR-0404 PRO-DENSE™ Extremity Graft 4cc
87SR-0410 PRO-DENSE™ Injectable Graft 10cc
87SR-0420 PRO-DENSE™ Injectable Graft 20cc
87SR-CK15 PRO-DENSE™ CDK 15cc

STRONGER THAN NORMAL BONE*: At 13 weeks; Urban, et al… CORR, June 2007.

FASTER THAN AUTOGRAFT*: The accelerated rate of healing of the PRO-DENSE™ graft treated defects compared to those treated with autograft is principally evident by the higher density bone (i.e., 170% average increase in area fraction of new bone compared to autograft at 13 weeks) and superior average mechanical properties at 13 weeks.

DENSER THAN AUTOGRAFT*: Histomorphometry reveals that the amount of newly regenerated bone of the PRO-DENSE™ injectable graft treated defects at 13 weeks demonstrated a statistically significant 170% average increase in new bone formation versus defects treated with autograft. PRO-DENSE™ injectable graft new bone area fraction is on average 170% denser than autograft at 13 weeks.

STRONGER THAN AUTOGRAFT*: The newly regenerated bone in the PRO-DENSE™ injectable graft treated defects exhibited a 645% average increase in compressive strength at 13 weeks versus defects treated with autograft.

*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.

See package insert for indications, contraindications, and warnings.

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