Materials & Processes for Medical Devices (August 10- 13): Outcomes In the Treatment of Benign Bone Lesions Using An Engineered Bioceramic

7.3 Outcomes In the Treatment of Benign Bone Lesions Using An Engineered Bioceramic

Tuesday, August 11, 2009: 11:20 AM
Salon G (Hilton Minneapolis )
Dr. Steven Gitelis , Rush University Medical Center, Chicago, IL
PURPOSE:

Benign bone tumors frequently are managed with bone grafting. We have previously reported on an engineered bioceramic (Pro-Dense®) tested in a critical sized defect in dogs. This material exceeded autogenous graft in the amount of bone repair and strength achieved. The purpose of this paper is to retrospectively review our clinical outcomes with this bioceramic.

MATERIAL AND METHODS:

Between May 2006 to April 2008, 100 consecutive patients were treated for a benign bone lesion with Pro-Dense®, injectable graft, Wright Medical Technology, Inc, Arlington, TN. Either open intra-lesional or percutaneous injection procedures were performed. The follow-up average was 12.5 months (85 patients had at least 6 months of follow-up). There were 49 male and 51 females, with an average age of 19.5 (range 4-63). The diagnoses; 24 UBC, 17 ABC, 15 NOF, 15 Enchondroma, 8 Chondroblastoma, and 21 other. Sites; Humerus 28, Femur 21, Tibia 18, other 33. Functional scores using the MSTS system were obtained at latest follow-up.

RESULTS:

The average MSTS score was 29.3 (range 19-30). Four patients (4%) suffered a local recurrence. Three were initially treated with an open intra-lesional procedure and one percutaneous injection. Two patients healed with repeat excision and Pro-Dense® grafting, one healed with Pro-Dense® and autograft, and one patient is pending excision. There was a 2% infection and 3% fracture rate. All fractures healed with closed treatment.

CONCLUSIONS:

This novel CaSO4/CaPO4 composite (Pro-Dense®) seems a reasonable alternative to autogenous bone graft. The outcomes are comparable to other graft materials with a relatively low complication rate. Almost all patients achieved full function by 6 months. The recurrence rate is comparable to other reports treating benign bone tumors with intra-lesional excision. Percutaneous injection with Pro-Dense® for UBC's had a low local recurrence rate.