PRO-DENSE™ Injectable Regenerative Graft is a bone graft substitute that is a purely synthetic composite of calcium sulfate and calcium phosphate. These two materials are biocompatible and have been used in orthopedics for over 100 years. The formulation in PRO-DENSE™, however, is unique and has demonstrated excellent results in benign bone cysts and tumors.1 2 3
PRO-DENSE™ Injectable Regenerative Graft has been used clinically for almost a decade and currently is the only* bone graft substitute to be indicated specifically for use in benign bone cysts and tumors in patients 6 years and up. The product allows for an injection technique in simple or unicameral bone cysts, or as a backfill in tumors/cysts in open techniques.
*As of January 1, 2016
A generalized surgical technique is demonstrated below:
Localize the lesion under fluoroscopy. Create cortical access to facilitate curettage.
Using an image intensifier, excise the lesion using a curette to debride defect margins. Excised tissue should be sent to pathology for routine histological examination and culture.
Having debrided the defect area, use the included delivery needle to inject PRO-DENSE™ Injectable Regenerative Graft into the defect.
After implantation, the bone graft resorbs over time and allows the body to lay down dense, new bone. This is different than other bone graft materials that take much longer (sometimes years) to resorb and be replaced by bone. In most cases, PRO-DENSE™ Injectable Regenerative Graft can be seen radiographically (i.e. on x-ray or CT) during post-operative visits. The surgeon will define post-operative activity level as the material resorbs and new bone heals and replaces the graft. The below case examples demonstrate how the material can be seen on x-ray and be replaced by dense, new bone as the material is resorbed.
TWELVE YEAR-OLD MALE with a recurrent unicameral bone cyst of the right proximal humerus. Approximately 50cc of PRO-DENSE™ Injectable Regenerative Graft was used to completely fill the lesion. No complications were reported. New bone formation was detected at 7 weeks, and at 7 months, a small amount of the residual graft was left. At 3 and 12 months, radiographs show dense new bone formation. Patient was fully active at 10 weeks and remains at full activity at present.
EIGHT YEAR-OLD MALE with a giant cell tumor of the third metatarsal. Approximately 8cc of PRO-DENSE™ Injectable Regenerative Graft was used after surgical removal of the tumor. Healing of the bone can be seen as the graft resorbs and is replaced over time. By six months the graft appears to be fully resorbed and the bone has healed and remodeled. The patient was at full activity at 3 months, and there has been no recurrence of the tumor at the two year post-operative visit.
Individual results and activity levels vary after surgery and depend on many factors including: age, weight, and prior activity level. Please consult a physician for complete information regarding benefits, risks, and potential outcomes. There are risks and recovery times associated with surgery and there are certain individuals who should not undergo surgery.