Allograft Versus Bioactive Glass (BG-S53P4) in Pediatric Benign Bone Lesions: A Randomized Clinical Trial

Abstract

Background: Benign bone cysts in children have a high risk of recurrence after bone grafting. The optimal treatment and filling material for these lesions are currently unknown.

Methods: We compared cyst recurrence after intralesional curettage and filling with allograft versus bioactive glass (BG-S53P4; Bonalive) in a randomized clinical trial. The volume of recurrent cyst at 2-year follow-up was the primary outcome.

Results: Of 64 eligible children, 51 (mean age, 11.1 years) were randomized to undergo filling of the cyst using morselized allograft (26) or bioactive glass (25). Twelve (46%) of the children in the allograft group and 10 (40%) in the bioactive glass group developed a recurrence (odds ratio [OR] for bioactive glass = 0.79, 95% confidence interval [CI] = 0.25 to 2.56, p = 0.77). The size of the recurrent cyst did not differ between the allograft group (mean, 3.3 mL; range, 0 to 13.2 mL) and the bioactive glass group (mean, 2.2 mL; range, 0 to 16.6 mL, p = 0.43). After adjusting for the type of lesion (aneurysmal bone cyst versus other), bioactive glass also did not prevent larger (>1 mL) recurrent cysts (adjusted OR = 0.42, 95% CI = 0.13 to 1.40, p = 0.16). The Musculoskeletal Tumor Society score improved significantly (p ≤ 0.013) from preoperatively to the 2-year follow-up in both groups (to 28.7 for bioactive glass and 29.1 for bone graft). Four (15%) of the children in the allograft group and 6 (24%) in the bioactive glass group required a reoperation during the follow-up (OR for bioactive glass = 1.74, 95% CI = 0.43 to 7.09, p = 0.50).

Conclusions: Filling with bioactive glass and with allograft in the treatment of benign bone lesions provided comparable results in terms of recurrence and complications.

Level of evidence: Therapeutic Level I . See Instructions for Authors for a complete description of levels of evidence.

Fig. 1

CONSORT flowchart. Twenty-five patients with complete follow-up (2 years) per group were required according to a sample size calculation, and a total of 55 tickets were randomized in sealed envelopes in advance to allow for potential loss to follow-up.

Fig. 2

Figs. 2-A through 2-D An aneurysmal bone cyst in a 9-year-old boy. Fig. 2-A Preoperative radiograph. Fig. 2-B Preoperative T2-weighted MRI. Fig. 2-C Radiograph after intralesional curettage and filling of the defect using allograft. Fig. 2-D Radiograph showing a multiloculated recurrence at the 6-month follow-up.

Fig. 3

Figs. 3-A through 3-D An aneurysmal bone cyst in the proximal femur of an 11-year-old girl. Fig. 3-A Preoperative radiograph. Fig. 3-B Preoperative T1-weighted MRI. Fig. 3-C Radiograph after intralesional curettage, filling of the defect using bioactive glass, and locking-plate osteosynthesis. Fig. 3-D Radiograph showing a recurrence at the 2-year follow-up.

Fig. 4

Kaplan-Meier survival curve for recurrence.