Background:The quest for ideal bone graft substitutes still haunts orthopedic researchers. The impetus for this search of newer bone substitutes is provided by mismatch between the demand and supply of autogenous bone grafts. Bone banking facilities such as deep frozen and freeze-dried allografts are not so widely available in most of the developing countries. To overcome the problem, we have used partially decalcified, ethanol preserved, and domestic refrigerator stored allografts which are economical and needs simple technology for procurement, preparation, and preservation. The aim of the study was to assess the radiological and functional outcome of the partially decalcified allograft (by weak hydrochloric acid) in patients of benign lytic lesions of bone. Through this study, we have also tried to evolve, establish, and disseminate the concept of the bone bank.Materials and Methods:42 cases of lytic lesions of bone who were treated by decalcified (by weak hydrochloric acid), ethanol preserved, allografts were included in this prospective study. The allograft was obtained from freshly amputated limbs or excised femoral heads during hip arthroplasties under strict aseptic conditions. The causes of lytic lesions were unicameral bone cyst (n = 3), aneurysmal bone cyst (n = 3), giant cell tumor (n = 9), fibrous dysplasia (n = 12), chondromyxoid fibroma, chondroma, nonossifying fibroma (n = 1 each), tubercular osteomyelitis (n = 7), and chronic pyogenic osteomyelitis (n = 5). The cavity of the lesion was thoroughly curetted and compactly filled with matchstick sized allografts.Results:Quantitative assessment based on the criteria of Sethi et al. (1993) was done. There was complete assimilation in 27 cases, partial healing in 12 cases, and failure in 3 cases. Functional assessment was also done according to which there were 29 excellent results, 6 good, and 7 cases of failure (infection, recurrence, and nonunion of pathological fracture). We observed that after biological incorporation, the graft participates in bone physiology and morphology. We did not observe any adverse host graft antigenic reaction.Conclusions:We conclude that decalcified allograft is suitable alloimplant for use in benign lesions of bone, is easy to prepare and store, and is thus well suited for use in developing countries.
Background:Bone grafts are required to fill a cavity created after curettage of benign lytic lesions of the bone. To avoid the problems associated at donor site with autologous bone graft, we require allograft or bone graft substitutes. We evaluated the healing of lytic lesions after hydroxyapatite (HA) grafting by serial radiographs.Materials and Methods:Forty cases of benign lytic lesions of bone were managed by simple curettage and grafting using HA blocks. Commercially available HA of bovine origin (Surgiwear Ltd., Shahjahanpur, India) was used for this purpose. Mean duration of followup was 34.8 months (range 12–84 months). Mean patient age was 19.05 years (range 3–55 years). Radiological staging of graft incorporation was done as per criteria of Irwin et al. 2001.Results:In our series, two cases were in stage I. A total of 11 cases were in stage II and 27 were in stage III. Graft incorporation was radiologically complete by 15 months. Clinical recovery was observed before radiological healing. The average time taken to return to preoperative function was 3 months. Recurrence was observed in giant cell tumor (n = 3) and chondromyxoid fibroma (n = 1). There was no incidence of graft rejection, collapse, growth plate disturbances or antigenic response.Conclusions:We conclude that calcium HA is biologically acceptable bone graft substitute in the management of benign lytic lesions of bone.
Background: Triamcinolone hexacetonide (THA), a synthetic glucocorticoid with low solubility, can provide sustained pain relief and less systemic side effects in patients with knee osteoarthritis. This study aimed to characterize pharmacokinetic profile of THA-test product containing 20 mg/ml injectable suspension and compare its bioavailability with the standard reference in Indian patients with knee osteoarthritis. Methods: In this open-label, randomized, multicenter study, 44 adult patients were randomized (1:1; test n=23, reference n=21) to receive a single dose of test or reference products. The primary objective was to characterize the pharmacokinetic profile and compare bioavailability of both products via serum triamcinolone acetonide (TCA) concentration. Secondary objectives included safety and tolerability evaluation, impact on hypothalamic-pituitary-adrenal axis, and efficacy of test and reference products in reducing index knee pain. Results: Both products were absorbed with a median Tmax of 23.9 hours. Comparative bioavailability analysis demonstrated no statistically significant formulation effect for ln-transformed Cmax (1098.052 pg/ml for test, 1333.850 pg/ml for reference) and AUC0-t (159112.561 pg×h/ml for test, 211531.035 pg×h/ml for reference) for TCA. T/R ratio for Cmax was 82.3% and T/R ratio for AUC0-t was 75.2%, with >100% inter-subject variability for both Cmax and AUC0-t. Additionally, recovery time of cortisol levels of test and reference arms was 96 hours and 456 hours, respectively. Both products significantly reduced knee pain (p<0.0001). Conclusions: The test product provided lower systemic exposure and faster recovery of serum cortisol levels than the reference, while still providing similar beneficial effect in sustained index knee pain reduction.
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