Clinical data support
How well does Pro-Dense Work?
There are several peer-reviewed published reports on the use of Pro-Dense Graft in benign bone cysts and tumors.1-3 Complications and recurrence were on par or better than historical experience with bone graft obtained from the patient’s own body, allograft, or other synthetic bone graft.1-3
A brief summary of three peer-reviewed published report:
Gentile Article 1
"Treatment of Unicameral Bone Cysts in Pediatric Patients With an Injectable Regenerative Graft: A Preliminary Report"
This was a review of 16 patients with unicameral bone cysts (UBC) with radiographic (e.g., X-ray) endpoints. 93.7% (15/16) of patients demonstrated radiographic healing after a single procedure and 87.5% (14/16) of patients developed complete radiographic healing. Patients returned to full activities at a mean of 3.1 months (range, 1-6) and all patients were fully functional and pain-free at the last follow-up. One patient healed with defects and one patient had a persistent cyst, which was asymptomatic and required no further treatment.
No patients experienced a postoperative fracture or infection. The authors concluded, "The treatment of UBC in pediatric patients with curettage, decompression, and injection of a CaSO4-CaPO4 composite (Pro-Dense Graft) is a safe and cost-effective treatment with a low recurrence and complication rate when compared with conventional methods."
Evanview Article 2
"Use of a Calcium Sulfate–Calcium Phosphate Synthetic Bone Graft Composite in the Surgical Management of Primary Bone Tumors"
This was a review of 24 patients with different benign bone tumors in a more simplified functional outcomes study. In these 24 patients, the mean time to full weight bearing (i.e., walking unassisted) was 7.3 weeks (8.3 for upper extremity, 6.9 for lower extremity). There were two patients that sustained local recurrences, but no other complications related to the graft were reported. The authors stated, "The use of CaSO4/CaPO4 synthetic bone graft composite (Pro-Dense Graft) was associated with rapid biological integration and early functional return to activities of daily living with no complications related to the use of the synthetic bone graft."
Fillingham Article 3
"Function After Injection of Benign Bone Lesions with a Bioceramic"
This was a review of 56 patients with different benign bone tumors with the intent of understanding functional outcomes, which is a measure of normal function and pain, such as walking, dexterity, lifting, etc. The average score across these 56 patients was 29/30, which suggests good to excellent function. There were two postoperative fractures and three local recurrences.
The investigator additionally stated, "In the current series…only one of the 13 (8%) unicameral bone cysts treated percutaneously has required a second injection…Although it was not an intended outcome, Pro-Dense Graft appears to result in a lower recurrence rate after percutaneous treatment as compared with alternative treatment modalities."
References:
- Gentile JV, Weinert CR, Schlechter JA. Treatment of unicameral bone cysts in pediatric patients with an injectable regenerative graft: a preliminary report. J Pediatr Orthop. 2013;33:254-61.
- Evaniew N, Tan V, Parasu N, Ghert M, 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.
- Fillingham YA, Lenart BA, Gitelis S. Function after injection of benign bone lesions with a bioceramic. Clin Orthop Relat Res. 2012;470(7): 2014-20.
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