Budget impact analysis of demineralized bone matrix in combination with autograft in lumbar spinal fusion procedures for the treatment of lumbar degenerative disc disease in Spain.

OBJECTIVE: To estimate the budget impact (BI) of introducing local autograft (LA) combined with demineralized bone matrix (LA + DBM) in lumbar spinal fusion (LSF) procedures to treat lumbar degenerative disc disease (LDDD) in Spain. METHODS: A decision tree model was developed to evaluate the 4-year BI associated with introducing LA + DBM putty to replace currently available grafting methods, including iliac crest bone graft (ICBG), LA alone, and LA combined with beta-tricalcium phosphate (LA + ceramics), with 30%, 40%, and 30% market shares, respectively. The analysis was conducted for a hypothetical cohort of 100 patients with LDDD receiving LSF, assuming LA + DBM would replace 100% of the standard of care mix. The fusion rates extracted from the literature were validated by an expert panel. Costs (€2017) were obtained from different Spanish sources. Budget impact and incremental cost per successful fusion were calculated from the perspective of the Spanish National Health System (NHS). RESULTS: Over 4 years, replacing currently available options with LA + DBM for 100 patients resulted in an additional cost of €12,330 (€123/patient), and an additional 14 successful fusions, implying a cost of €881 per additional successful fusion. When costs of productivity loss were included, the introduction of LA + DBM resulted in cost savings of €70,294 (€703/patient). LIMITATIONS: The lack of high-quality, homogeneous, head-to-head research studying the efficacy of grafting procedures available to patients undergoing LSF, in addition to a lack of long-term follow-up in existing studies. Therefore, the number of fusions occurring within the model's time horizon may be underestimated. CONCLUSIONS: Acquisition costs of DBM were partially offset by costs of failed fusions, adverse events and reoperation when switching 100 hypothetical LDDD patients undergoing LSF procedures from standard of care grafting methods to LA + DBM from the perspective of the Spanish NHS. DBM cost was entirely offset when costs of lost productivity were considered.

Beta-tricalcium phosphate for orthopedic reconstructions as an alternative to autogenous bone graft.

Autogenous bone graft (autograft) remains the gold standard in the treatment of many orthopedic problems. However, graft harvest can lead to perioperative morbidity and increased cost. We tested the hypothesis that an osteoconductive matrix, beta-tricalcium phosphate (ß-TCP), would be a safe and effective alternative to autograft alone. Beta-tricalcium phosphate (ß-TCP) is considered as one of the most promising biomaterials for bone reconstruction. This study analyzes the outcomes of patients who received ß-TCP as bone substitutes in orthopedic surgery. METHODS: A total of 50 patients were enrolled in a controlled, non-inferiority clinical trial to compare the safety and efficacy of ß-TCP (25 patients) with those of autograft (25 patients) in indications requiring usually autograft. These 50 patients were categorized according to the etiology and morphology of the 54 bone defects resulting from elective surgical procedures, such as 34 open-wedge high tibial osteotomies, and 20 osteonecrosis treatments with core decompression. Radiographic (healing process with or without integration of ß-TCP), clinical (no other surgical procedure), functional outcomes and safety (with or without complications) were assessed through fifty-two weeks postoperatively. RESULTS: With regard to the primary endpoint (radiographic evolution), the fusion rate of the 34 open-wedge osteotomies was 100% (17 among 17) for patients in the group with ß-TCP compared with 94% (16 among 17) for patients in the autograft group. For the 20 cavitary defects (osteonecrosis), the radiographic union rates, as determined by the presence of osseous bridging, were 100% for patients in the group with ß-TCP and 100% for those in the autograft group. Clinically at one year, all quality-of-life and functional outcome data supported non-inferiority of ß-TCP compared with autograft, and patients in the ß-TCP group were found to have less pain and an improved safety profile. CONCLUSIONS: Treatment with ß-TCP resulted in comparable fusion rates, less pain and fewer side effects as compared with treatment with autograft. This study established clinical parameters where the ß-TCP alone can successfully support the osteogenic process.

Efficacy of a supersaturated calcium phosphate oral rinse for the prevention and treatment of oral mucositis in patients receiving high-dose cancer therapy: a review of current data.

Oral mucositis (OM) is a painful and debilitating complication of cancer therapy that can adversely affect patients' treatment regimens and quality of life. It is also considered to be a substantial burden on the financial and human resources of health services. Despite progress in the understanding of the pathophysiology of OM and the number of new treatments that have been developed, there remains an unmet need for effective preventative measures in clinical practice. Literature on oral healthcare management in oncology patients suggests that a preventative approach consisting of a supersaturated Ca2+ / PO4(3-) oral rinse (Caphosol(®)) aimed at maintaining oral hygiene, moistening and lubricating the oral cavity, effectively reduces the incidence and severity of OM. This review looked at data from all known adult and paediatric studies investigating the use of Caphosol(®) in patients receiving high-dose cancer therapy in order to evaluate its efficacy for both the prevention and treatment of OM. Thirty studies were identified. The majority of these studies (n = 24) found Caphosol(®) to be efficacious at reducing the grade and/or duration, as well as pain associated with OM. Despite important limitations, these data warrant serious consideration for the inclusion of Caphosol(®) in regimens for preventing or reducing the debilitating effects of OM.

Endoscopic delivery of calcium phosphate cement for secondary craniofacial reconstruction.

Contour defects are common following primary craniofacial procedures including cranial vault remodeling, fronto-orbital and midface advancements, and complex posttraumatic reconstructions. When onlayed as fast-setting pastes, calcium phosphate cements (CPCs) have been used to effectively correct contour defects in open secondary reconstruction procedures. Here, we describe an endoscopic procedure using an injectable CPC and compare surgical outcomes with the open technique. A retrospective review was conducted for 36 consecutive patients aged 3.0-28.9 years (mean, 10.1 years) who underwent secondary craniofacial reconstruction over a 3-year period. Patients were stratified into endoscopic or open groups depending on the surgical approach utilized. Mean operative time was significantly shorter (P < 0.001) for the endoscopic group (64 minutes) than for the open group (131 minutes). Similarly, hospital stay was significantly shorter (P = 0.005) in the endoscopic group than in the open group. There was also a significant difference with respect to cost (P < 0.001), with the endoscopic approach resulting in a per-patient cost savings of $2208.05. In conclusion, endoscopic delivery of CPC appears to be a safe, efficacious, and cost-effective method of performing secondary craniofacial reconstruction, with the additional benefits of decreased operative time and shorter postoperative hospital stay when compared with an open procedure.

Bone graft substitutes in hip revision surgery: a comprehensive overview.

INTRODUCTION: Total hip replacement is increasingly used to treat diseased and damaged joints. With time, some joint replacements may require revision, mainly because of instability and mechanical loosening, and this is of particularly significance to younger patients. A major problem in revision surgery is the loss of bone stock and the consequent difficulty in reconstructing a stable joint. Loss of bone stock has been widely treated using bone autografts and allografts but supplies are limited. Use of bone graft substitutes in combination with, or as a substitute for, human bone is a possible alternative. AIM: To identify empirical studies of bone graft substitutes in hip revision surgery. METHODS: Systematic review based on Cochrane and MOOSE methods. We searched MEDLINE and EMBASE to December 2010 with terms relating to hip replacement and bone graft substitutes, and checked key citations in ISI Web of Science and reference lists. We considered all human studies irrespective of study design. RESULTS: Searches identified 397 articles. Screening of abstracts and full text articles identified 7 studies reporting outcomes of bone-graft substitute combined with autograft or allograft, and 6 studies reporting outcomes of bone graft substitute exclusively. One economic evaluation compared costs of femoral head banking with costs of bone graft substitutes. No randomised controlled trials evaluating bone graft substitute effectiveness were identified. Studies generally included small numbers of patients with a follow up too short to assess outcomes relating to implant survival. However, excepting those based on glass ceramic, ceramic bone graft substitutes show promise as an alternative to use of exclusive autograft or allograft. In the case of calcium phosphate ceramic bone graft substitute, potential cost savings were evident. CONCLUSION: With increased allograft shortage, bone graft substitutes will be required in hip revision surgery. However, appropriately designed randomised controlled trials are required to compare use of existing and new bone graft substitutes with established practice. As well as prosthesis related outcomes, studies should explore the patient experience of revision hip replacement with bone graft substitute material.

Calcium-vitamin D3 supplementation is cost-effective in hip fractures prevention.

OBJECTIVE: To assess the cost implications for a preventive treatment strategy for institutionalised elderly women with a combined 1200 mg/day calcium and 800 IU/day vitamin D(3) supplementation in seven European countries. DESIGN: Retrospective cost effectiveness analysis based on a prospective placebo-controlled randomised clinical trial. DATA SOURCES: Recently published cost studies in seven European countries. Clinical results from Decalyos, a 3-year placebo-controlled study in elderly institutionalised women. TRIALS: Decalyos study, with 36 months follow-up of 3270 mobile elderly women living in 180 nursing homes, allocated to two groups. One group received 1200 mg/day elemental calcium in the form of tricalcium phosphate together with 800 IU/day (20 microg) of cholecalciferol (vitamin D(3)), the other placebo. RESULTS: In the 36 months analysis of the Decalyos study, 138 hip fractures occurred in the group of 1176 women, receiving supplementation and 184 hip fractures in the placebo group of 1127 women. The mean duration of treatment was 625.4 days. Adjusted to 1000 women, 46 hip fractures were avoided by the calcium and vitamin D(3) supplementation. For all countries, the total costs in the placebo group were higher than in the group receiving supplementation, resulting in a net benefit of 79000-711000 per 1000 women. CONCLUSION: This analysis suggests that the supplementation strategy is cost saving. The results may underestimate the net benefits, as this treatment has also shown to be effective in decreasing the incidence of other non-vertebral fractures in elderly institutionalised women.