The Clinical Use of Osteobiologic and Metallic Biomaterials in Orthopedic Surgery: The Present and the Future.

As the area and range of surgical treatments in the orthopedic field have expanded, the development of biomaterials used for these treatments has also advanced. Biomaterials have osteobiologic properties, including osteogenicity, osteoconduction, and osteoinduction. Natural polymers, synthetic polymers, ceramics, and allograft-based substitutes can all be classified as biomaterials. Metallic implants are first-generation biomaterials that continue to be used and are constantly evolving. Metallic implants can be made from pure metals, such as cobalt, nickel, iron, or titanium, or from alloys, such as stainless steel, cobalt-based alloys, or titanium-based alloys. This review describes the fundamental characteristics of metals and biomaterials used in the orthopedic field and new developments in nanotechnology and 3D-printing technology. This overview discusses the biomaterials that clinicians commonly use. A complementary relationship between doctors and biomaterial scientists is likely to be necessary in the future.

Assessing the effects of National Health Insurance reimbursement policy revisions for anti-osteoporotic drugs in Korean women aged 50 or older.

INTRODUCTION: The Korean National Health Insurance revised its reimbursement criteria to expand coverage for anti-osteoporotic drug treatments in 2011 (expanding diagnostic criteria and the coverage period for anti-osteoporotic therapy) and 2015 (including osteoporotic fracture patients regardless of bone mineral density). We examined whether the two revisions contributed to an increase in the prescription rates of anti-osteoporotic drugs in Korea. METHODS: We used the Health Insurance Review and Assessment Service-National Patient Sample data from 2010 through 2016. A segmented regression analysis of interrupted time series was performed to assess changes in the monthly prescription rates of anti-osteoporotic drugs among women aged 50 or older, defined as the proportion of elderly women prescribed with anti-osteoporotic drugs. RESULTS: Both the levels (i.e., abrupt jump or drop) and the trends (i.e., slope) of the prescription rates of anti-osteoporotic drugs in the general population, osteoporotic patients, and osteoporotic fracture patients showed no significant changes after the first revision. However, there was a significant increase in the trends in the general population (ß = 0.0166, p = 0.0173) and in osteoporotic patients (ß = 0.1128, p = 0.0157) after the second revision. Women aged 65 to 79 years were the most significantly increased group in terms of the treatment proportion after the second revision because the trend was significant after the second revision in all three study populations (ß = 0.0300, 0.1212, 0.1392, respectively; p < 0.05). CONCLUSIONS: Although the two revisions expanded reimbursement coverage, only the second revision on reimbursing based on osteoporotic fracture regardless of bone mineral density was associated with increasing the proportion of post-menopausal women being treated with anti-osteoporotic drugs.

Hand grip strength can predict clinical outcomes and risk of falls after decompression and instrumented posterolateral fusion for lumbar spinal stenosis.

BACKGROUND CONTEXT: There has been limited research on the association between hand grip strength (HGS) as one of the diagnostic criteria for sarcopenia and surgical outcomes of lumbar spinal stenosis (LSS). PURPOSE: We aimed to determine the effect of HGS on surgical outcomes and risk of fall in patients with LSS. STUDY DESIGN: This is a retrospective observational study. PATIENT SAMPLE: We included 200 patients who underwent spinal surgery for LSS. OUTCOME MEASURES: We recorded clinical outcome parameters, including Oswestry Disability Index (ODI), Euro-QOL (EQ-5D), and visual analog scale (VAS) scores for back or leg pain. To assess the risk of fall we used HGS and four functional mobility tests (alternative step test, six-meter walk test, timed up and go test, sit-to-stand test). MATERIALS AND METHODS: ODI, EQ-5D, and VAS scores for back and leg pain were assessed preoperatively and 1 year after surgery. The four functional mobility tests were assessed at each time point during the 1-year follow-up period to assess the risk of fall in patients with LSS. We divided the patient cohort according to sex and allocated them into two different groups based on HGS: high HGS (≥26 kg for men, n=26; ≥18 kg for women, n=35), and low HGS (<26 kg for men, n=48; <18 kg for women, n=91). The pre- and postoperative ODI, EQ-5D, and VAS scores for back and leg pain, as well as the functional mobility test results, and demographic data were compared between the two groups using independent t tests. Correlations between HGS and clinical outcome parameters were analyzed using Pearson correlation. RESULTS: In women and men, HGS correlated with the preoperative/postoperative ODI (r1=-0.217/r2=-0.345 in women, and r1=-0.384/r2=-0.411 in men) and EQ-5D scores (r1=0.190/r2=0.309 in women, and r1=0.373/r2=0.467 in men). HGS also correlated with the four postoperative results for the functional mobility tests: alternative step test (r=-0.238 in women, r=-0.431 in men), six-meter walk test (r=-0.232 in women, r=-0.282 in men), timed up and go test (r=-0.285 in women, r=-0.359 in men), and sit-to-stand test (r=-0.238 in women, r=-0.251 in men). The preoperative and postoperative ODI and EQ-5D scores in the high HGS group were superior to those in the low HGS group. Among the four functional mobility tests, preoperative and postoperative six-meter walk test results showed improvements in the high HGS group. CONCLUSIONS: Considering the multifactorial nature of falls, HGS may be a useful surrogate marker for predicting the risk of falls and clinical outcomes in patients with LSS.

Risk Factors of Clostridium Difficile Infection After Spinal Surgery: National Health Insurance Database.

The purpose of this study was to evaluate risk factors of Clostridium Difficile infection (CDI) after spinal surgery using the Health Insurance Review and Assessment Service (HIRA) data. The incidence of postoperative CDI was investigated using HIRA data from 2012 to 2016. Cases involving CDI that occurred within a 30-day postoperative period were identified. Risk factors, including age, sex, comorbidities, postoperative infection, spinal surgery procedure, type of antibiotic, and duration of antibiotic use, were evaluated. Duration of hospital stay, medical cost, and mortality were also evaluated. In total, 71,322 patients were included. Presumed cases of CDI were identified in 57 patients, with CDI rate of 0.54 per 10,000 patient days. Advanced age, staged operation, postoperative infection, and the use of multiple antibiotics were significant risk factors. First-generation cephalosporins were shown to be associated with a lower incidence of CDI. CDI was also associated with longer hospital stays and increased medical cost, and it was an independent risk factor for increased mortality. Extra attention should be paid to patients at high risk for the development of postoperative CDI, and unnecessary use of multiple antibiotics should be avoided. Level of Evidence: Level III, retrospective cohort study.

A comparative study of the efficacy of NAXOZOL compared to celecoxib in patients with osteoarthritis.

OBJECTIVE: Selective cyclooxygenase-2 inhibitors (celecoxib) can minimize the gastrointestinal complications related to non-steroidal anti-inflammatory drug (NSAID) use. NAXOZOL is a new combination formulation designed to provide sequential delivery of a non-enteric-coated, immediate-release esomeprazole strontium tetrahydrate 20 mg mantle followed by an enteric-coated naproxen 500 mg core. However, there have been no studies comparing NAXOZOL to celecoxib with respect to gastrointestinal tract protection and pain relief in patients with osteoarthritis. This study was undertaken to compare the effects of NAXOZOL and celecoxib with respect to gastrointestinal tract protection and pain relief in patients with osteoarthritis. METHODS: The randomized enrolled patients were divided into two treatment groups: a NAXOZOL group and a celecoxib group. All participants received treatments (NAXOZOL, 500/20 mg (naproxen 500 mg, esomeprazole strontium tetrahydrate 20 mg) twice per day versus celecoxib, 200 mg daily) on a 1:1 allocation basis for 12 weeks. The primary outcome was the Leeds Dyspepsia Questionnaire (LDQ) score used for non-inferiority testing. Secondary outcome measures included the Gastrointestinal Symptom Rating Scale (GSRS) score, Visual Analogue Scale (VAS) score, European Quality of Life-5 dimensions (EQ-5D) scale and the EQ-5D Visual Analogue Scale (EQ VAS). Other outcome measures included the use of supplementary or rescue drugs, and the incidence of adverse events. RESULTS: The baseline-adjusted LDQ scores immediately after 12 weeks of treatment in NAXOZOL group were not inferior to those in celecoxib group. The overall change in the baseline-adjusted GSRS score, VAS score, EQ-5D, and EQ VAS was not different between the two groups. The usage of supplementary drugs and the drug-related incidence of adverse events were not different. However, the days to use rescue drug were longer in celecoxib group than in NAXOZOL group. CONCLUSION: NAXOZOL was not inferior to celecoxib in protecting the gastrointestinal tract and providing pain relief in patients with osteoarthritis.

Cost-effectiveness of Pharmaceutical Interventions to Prevent Osteoporotic Fractures in Postmenopausal Women with Osteopenia.

BACKGROUND: To assess the cost-effectiveness of drug therapy to prevent osteoporotic fractures in postmenopausal women with osteopenia in Korea. METHODS: A Markov cohort simulation was conducted for lifetime with a hypothetical cohort of postmenopausal women with osteopenia and without prior fractures. They were assumed to receive calcium/vitamin D supplements only or drug therapy (i.e., raloxifene or risedronate) along with calcium/vitamin D for 5 years. The Markov model includes fracture-specific and non-fracture specific health states (i.e. breast cancer and venous thromboembolism), and all-cause death. Published literature was used to determine the model parameters. Local data were used to estimate the baseline incidence rates of fracture in those with osteopenia and the costs associated with each health state. RESULTS: From a societal perspective, the estimated incremental cost-effectiveness ratios (ICERs) for the base cases that had T-scores between -2.0 and -2.4 and began drug therapy at the age of 55, 60, or 65 years were $16,472, $6,741, and -$13,982 per quality-adjusted life year (QALY) gained, respectively. Sensitivity analyses for medication compliance, risk of death following vertebral fracture, and relaxing definition of osteopenia resulted in ICERs reached to $24,227 per QALY gained. CONCLUSIONS: ICERs for the base case and sensitivity analyses remained within the World Health Organization's willingness-to-pay threshold, which is less than per-capita gross domestic product in Korea (about $25,700). Thus, we conclude that drug therapy for osteopenia would be a cost-effective intervention, and we recommend that the Korean National Health Insurance expand its coverage to include drug therapy for osteopenia.

A comparison of autologous and homologous transfusions in spinal fusion.

Autologous transfusion has been used to overcome adverse effects of homologous transfusion. Clinical studies evaluating general orthopaedic postoperative results have been designed to compare these transfusion methods. However, few studies have evaluated postoperative results in spinal fusion surgeries, which have larger blood loss volumes. The purpose of this study is to determine if there are differences in postoperative infection and clinical results of spinal fusion with autologous, as compared to homologous, blood transfusion. A total of 62 patients who underwent instrumented spinal fusion and received autologous (n = 30) or homologous (n = 32) transfusions were reviewed. Information on gender, age, preoperative and 3-day postoperative hematologic features, total transfused units, segmental estimated blood loss, transfused units, and surgery time were collected. In addition, postoperative infection data on wound infection, pneumonia, urinary tract infection, cellulitis, and viral disease, incidence and duration of fever, as well as clinical results, fusion rates, and patient feedback were collected. No differences in postoperative infection and clinical results were found between the two types of transfusions; however, homologous transfusion was associated with an increased number of total units transfused, longer duration of fever, and decreased patient satisfaction regarding the transfusion.