Local administration of vancomycin powder in orthopaedic fracture surgery: current practice and trends.

Objectives: Surgical site infections in orthopaedic trauma are a significant problem with meaningful patient and health care system-level consequences. Direct application of antibiotics to the surgical field has many potential benefits in reducing surgical site infections. However, to date, the data regarding the local administration of antibiotics have been mixed. This study reports on the variability of prophylactic vancomycin powder use in orthopaedic trauma cases across 28 centers. Methods: Intrawound topical antibiotic powder use was prospectively collected within three multicenter fracture fixation trials. Fracture location, Gustilo classification, recruiting center, and surgeon information were collected. Differences in practice patterns across recruiting center and injury characteristics were tested using chi-square statistic and logistic regression. Additional stratified analyses by recruiting center and individual surgeon were performed. Results: A total of 4941 fractures were treated, and vancomycin powder was used in 1547 patients (31%) overall. Local administration of vancomycin powder was more frequent in open fractures 38.8% (738/1901) compared with closed fractures 26.6% (809/3040) (P < 0.001). However, the severity of the open fracture type did not affect the rate at which vancomycin powder was used (P = 0.11). Vancomycin powder use varied substantially across the clinical sites (P < 0.001). At the surgeon level, 75.0% used vancomycin powder in less than one-quarter of their cases. Conclusions: Prophylactic intrawound vancomycin powder remains controversial with varied support throughout the literature. This study demonstrates wide variability in its use across institutions, fracture types, and surgeons. This study highlights the opportunity for increased practice standardization for infection prophylaxis interventions. Level of Evidence: Prognostic-III.

Delays in hospital admissions in patients with fractures across 18 low-income and middle-income countries (INORMUS): a prospective observational study.

BACKGROUND: The Lancet Commission on Global Surgery established the Three Delays framework, categorising delays in accessing timely surgical care into delays in seeking care (First Delay), reaching care (Second Delay), and receiving care (Third Delay). Globally, knowledge gaps regarding delays for fracture care, and the lack of large prospective studies informed the rationale for our international observational study. We investigated delays in hospital admission as a surrogate for accessing timely fracture care and explored factors associated with delayed hospital admission. METHODS: In this prospective observational substudy of the ongoing International Orthopaedic Multicenter Study in Fracture Care (INORMUS), we enrolled patients with fracture across 49 hospitals in 18 low-income and middle-income countries, categorised into the regions of China, Africa, India, south and east Asia, and Latin America. Eligible patients were aged 18 years or older and had been admitted to a hospital within 3 months of sustaining an orthopaedic trauma. We collected demographic injury data and time to hospital admission. Our primary outcome was the number of patients with open and closed fractures who were delayed in their admission to a treating hospital. Delays for patients with open fractures were defined as being more than 2 h from the time of injury (in accordance with the Lancet Commission on Global Surgery) and for those with closed fractures as being a delay of more than 24 h. Secondary outcomes were reasons for delay for all patients with either open or closed fractures who were delayed for more than 24 h. We did logistic regression analyses to identify risk factors of delays of more than 2 h in patients with open fractures and delays of more than 24 h in patients with closed fractures. Logistic regressions were adjusted for region, age, employment, urban living, health insurance, interfacility referral, method of transportation, number of fractures, mechanism of injury, and fracture location. We further calculated adjusted relative risk (RR) from adjusted odds ratios, adjusted for the same variables. This study was registered with ClinicalTrials.gov, NCT02150980, and is ongoing. FINDINGS: Between April 3, 2014, and May 10, 2019, we enrolled 31 255 patients with fractures, with a median age of 45 years (IQR 31-62), of whom 19 937 (63·8%) were men, and 14 524 (46·5%) had lower limb fractures, making them the most common fractures. Of 5256 patients with open fractures, 3778 (71·9%) were not admitted to hospital within 2 h. Of 25 999 patients with closed fractures, 7141 (27·5%) were delayed by more than 24 h. Of all regions, Latin America had the greatest proportions of patients with delays (173 [88·7%] of 195 patients with open fractures; 426 [44·7%] of 952 with closed fractures). Among patients delayed by more than 24 h, the most common reason for delays were interfacility referrals (3755 [47·7%] of 7875) and Third Delays (cumulatively interfacility referral and delay in emergency department: 3974 [50·5%]), while Second Delays (delays in reaching care) were the least common (423 [5·4%]). Compared with other methods of transportation (eg, walking, rickshaw), ambulances led to delay in transporting patients with open fractures to a treating hospital (adjusted RR 0·66, 99% CI 0·46-0·93). Compared with patients with closed lower limb fractures, patients with closed spine (adjusted RR 2·47, 99% CI 2·17-2·81) and pelvic (1·35, 1·10-1·66) fractures were most likely to have delays of more than 24 h before admission to hospital. INTERPRETATION: In low-income and middle-income countries, timely hospital admission remains largely inaccessible, especially among patients with open fractures. Reducing hospital-based delays in receiving care, and, in particular, improving interfacility referral systems are the most substantial tools for reducing delays in admissions to hospital. FUNDING: National Health and Medical Research Council of Australia, Canadian Institutes of Health Research, McMaster Surgical Associates, and Hamilton Health Sciences.

Knowledge Dissemination of Intimate Partner Violence Intervention Studies Measured Using Alternative Metrics: Results From a Scoping Review.

Alternative metrics measure the number of online mentions that an academic paper receives, including mentions in social media and online news outlets. It is important to monitor and measure dispersion of intimate partner violence (IPV) victim intervention research so that we can improve our knowledge translation and exchange (KTE) processes improving utilization of study findings. The objective of this study is to describe the dissemination of published IPV victim intervention studies and to explore which study characteristics are associated with a greater number of alternative metric mentions and conventional citations. As part of a larger scoping review, we conducted a literature search to identify IPV intervention studies. Outcomes included znumber of alternative metric mentions and conventional citations. Fifty-nine studies were included in this study. The median number of alternative metric mentions was six, and the median number of conventional citations was two. Forty-one percent of the studies (24/59) had no alternative metric mentions, and 27% (16/59) had no conventional citations. Longer time since publication was significantly associated with a greater number of mentions and citations, as were systematic reviews and randomized controlled trial designs. The majority of IPV studies receive little to no online attention or citations in academic journals, indicating a need for the field to focus on implementing strong knowledge dissemination plans. The papers receiving the most alternative metric mentions and conventional citations were also the more rigorous study designs, indicating a need to focus on study quality. We recommend using alternative metrics in conjunction with conventional metrics to evaluate the full dissemination of IPV research.

A multicenter observational study on the distribution of orthopaedic fracture types across 17 low- and middle-income countries.

OBJECTIVES: To describe the regional distribution of fractures sustained by women and health care system characteristics across 17 low- and middle-income countries (LMICs). METHODS: The INternational ORthopaedic MUlticentre Study in fracture care (INORMUS) is an observational study collecting data on patients in LMICs who sustained a fracture or musculoskeletal injury. As a planned analysis for the INORMUS study, we explored differences in fracture locations and demographics reported among 9878 female patients who sustained a fracture within 17 LMICs in 5 regions (China, Africa, India, Other Asia, and Latin America). RESULTS: Half of our study population (49.6%) was ≥60 years of age. Across all regions, 58.3% of patients possessed health insurance. Latin America possessed the highest proportion (88.8%) of health insurance, while in Africa, patients possessed the lowest (18.0%). Falls from standing were the most prevalent mechanism of injury (51.7%) followed by falls from height (12.8%) and motorcycle-related road traffic injuries (9.7%). The majority of the fractures (65.6%) occurred in patients aged 50 and older. Hip fractures were the most common fracture (26.8%), followed by tibia/fibula (12.6%) and spine fractures (9.7%). Open fractures accounted for 7.6% of fractures and were most commonly tibia/fibula fractures (35.1%). Despite these severe injuries, less than one-third (28.8%) of patients were transported for care after sustaining a fracture by ambulance. Regionally, a majority of female patients in Africa were working age and suffered tibia/fibula (21.6%) and femur fractures (14.0%). Patients in the regional category Other Asia, suffered the highest frequencies of open fractures (9.6% low grade, 7.1% high grade), and disproportionately from motorcycle road traffic injuries (29.9%). CONCLUSION: Across all regions, the most significant source of fracture burden was in the elderly, and included common fragility fractures, such as hip fractures. Notable regional deviations in fracture distributions were observed within Africa, and Other Asia. Across all studied LMICs, ambulance usage was low, and health insurance coverage was particularly low in Africa and India.

International Orthopaedic Multicenter Study in Fracture Care: Coordinating a Large-Scale Multicenter Global Prospective Cohort Study.

Traditionally, the orthopaedic trauma literature has been dominated by small studies that were largely single-center initiatives. More recently, there has been a paradigm shift toward larger, multicenter studies because the orthopaedic community embraced the concepts of evidence-based medicine and the need for high-quality research to guide clinical practice. The International Orthopaedic Multicenter Study in Fracture Care is a large multicenter international cohort study in musculoskeletal trauma in Africa, Asia, and Latin America. This is the first study of this magnitude within the global orthopaedic trauma community. The International Orthopaedic Multicenter Study in Fracture Care study has provided an opportunity to form new international collaborative relationships and to develop new research capacity and global collaborative relationships that will provide the foundation for future studies in injury prevention and management. LEVELS OF EVIDENCE: IV.

Intra-articular Injections in the Treatment of Symptoms from Ankle Arthritis: A Systematic Review.

BACKGROUND: Intra-articular (IA) injections are commonly used to treat knee arthritis pain; however, whether their efficacy generalizes to ankle arthritis remains debatable. We aimed to evaluate the evidence for IA therapies in the management of this patient population. METHODS: We performed a literature search for observational and randomized controlled trials (RCTs). Treatments included corticosteroids (CS), hyaluronic acid (HA), platelet-rich plasma (PRP), and mesenchymal stem cells (MSC). We extracted study details, patient demographics, treatment characteristics, efficacy outcomes, and safety. When feasible, data from RCTs were meta-analyzed using a random-effects model and 95% confidence intervals (CIs) were calculated. A P value <.05 was considered statistically significant. RESULTS: We identified 27 studies (1085 patients). Ankle OA, rheumatoid arthritis (RA), and hemophilic arthropathy populations were examined. The majority of studies were observational (20 studies); the only RCTs were those evaluating HA. Case series demonstrated favorable results in terms of symptomatic relief with CS, HA, PRP, and MSC injections; however, the effects of CS may only be short term and the evidence on MSCs was limited to 1 study with 6 ankle OA patients. Pooled results (3 RCTs, 109 patients) suggested significantly improved Ankle Osteoarthritis Scale scores with HA over saline at 6 months, with a mean difference of 12.47 points (95% CI 1.18-23.77, P = .03). CONCLUSION: Evidence from small trials favors HA and PRP injections for the treatment of pain associated with ankle osteoarthritis. However, the relative efficacy of all injectable therapies is far from definitive and warrants further high-quality comparative trials. LEVEL OF EVIDENCE: Level III, systematic review.

Treatment of Osteoarthritis of the Knee with Bracing: A Scoping Review.

Knee osteoarthritis is a leading cause of disability around the world. Knee bracing provides a conservative management option for symptom relief. A variety of different bracing types, manufacturers and products are currently available on the market. The goal of this study is to examine the current state of the literature regarding the treatment of knee osteoarthritis with unloader bracing, specifically examining the representation of specific brace types, manufacturers and models within the literature. A scoping review technique was used because of its ability to evaluate research activity within an area of study and identify gaps within the literature. A thorough search of the MEDLINE database was conducted for articles where a knee brace model was identified, and we identified characteristics of the studies to evaluate important information about the body of literature related to knee bracing for the treatment of osteoarthritis. Fifty eligible studies were identified. The majority of studies have been published in the United States, and a large increase in the number of publications in this field was seen between 2010-2014. The most prominent study type was prospective comparative studies (44%), however there is a lack of randomized controlled trials (6%) within the literature. The most prominent hinge type within the literature is the dual hinge push brace, followed by the single hinge pull. While a large increase in the number of studies evaluating the treatment of knee osteoarthritis with bracing has occurred in the past 5 years, there is a lack of high quality studies evaluating the efficacy of the technique, as well as a lack of studies comparing bracing types and models.

Safety and Feasibility of a KineSpring Knee System for the Treatment of Osteoarthritis: A Case Series.

The treatment gap between conservative management and total knee arthroplasty may leave patients with moderate cases of knee osteoarthritis (OA) without an ideal treatment option. The KineSpring(®) Knee Implant System may be a viable treatment option to fill the treatment gap for patients with knee OA who are not willing or inappropriate candidates for total knee arthroplasty, yet do not demonstrate relief with conservative treatments. This current paper reports a series of patients who received the KineSpring System and were followed for five years. Twelve patients were included in the case series. All 12 patients were diagnosed with symptomatic OA of the medial compartment of the knee. Pain and functional problems associated with OA improved with treatment using the KineSpring System. Furthermore, these improvements were seen over the course of five years. The findings of this study show the KineSpring System as a promising intervention for early-onset OA and warrant further investigation regarding its effectiveness.

The Use of Carbon-Fiber-Reinforced (CFR) PEEK Material in Orthopedic Implants: A Systematic Review.

Carbon-fiber-reinforced polyetheretherketone (CFR-PEEK) has been successfully used in orthopedic implants. The aim of this systematic review is to investigate the properties, technical data, and safety of CFR-PEEK biomaterial and to evaluate its potential for new innovation in the design of articulating medical devices. A comprehensive search in PubMed and EMBASE was conducted to identify articles relevant to the outcomes of CFR-PEEK orthopedic implants. The search was also expanded by reviewing the reference sections of selected papers and references and benchmark reports provided by content experts. A total of 23 articles were included in this review. There is limited literature available assessing the performance of CFR-PEEK, specifically as an implant material for arthroplasty systems. Nevertheless, available studies strongly support CFR-PEEK as a promising and suitable material for orthopedic implants because of its biocompatibility, material characteristics, and mechanical durability. Future studies should continue to investigate CFR-PEEK's potential benefits.

Cost Effectiveness and Economic Impact of the KineSpring Knee Implant System in the Treatment of Knee Osteoarthritis in Spain.

We investigated the efficacy and cost effectiveness of the KineSpring System in the Spanish healthcare system, as compared to other standard treatments methods. Cost-utility ratios were calculated using derived cost data and we calculated quality-adjusted life years (QALYs) gained for each method of treatment. Cost-utility ratios were calculated assuming lifetime and 10-year durability. Assuming lifetime durability, cost-utility ratios of total knee arthroplasty (TKA), unicompartmental knee arthroplasty (UKA), high tibial osteotomy (HTO), KineSpring System, and conservative treatments, compared to no treatment, are €2348 ± 70/QALYs, €2040 ± 61/QALYs, €2281 ± 68/ QALY, €1669 ± 268/QALYs, and €11,688 ± 2185/QALYs, respectively. Assuming a treatment durability of 10 years, the cost-utility ratio of TKA, UKA, HTO, KineSpring System, and conservative treatments, compared to no treatment, are €4884 ± 323/QALYs, €4243 ± 280/QALYs, €4744 ± 313/QALYs, €3757 ± 1353/QALYs, and €10,575 ± 4414/QALYs, respectively. In comparison to current standard-of-care treatments, the KineSpring System has a favorable cost-utility ratio, making it an effective treatment option and a suitable cost-saving alternative. The KineSpring System is associated with lower cost and increased QALYs.

Orthopedic Implant Value Drivers: A Qualitative Survey Study of Hospital Purchasing Administrators.

Osteoarthritis (OA) is a chronic, degenerative disease that is highly prevalent in the population, yet the factors that affect purchasing decisions related to this condition are poorly understood. A questionnaire was developed and administered to hospital executives across North America to determine the factors that affect purchasing decisions related to OA. Thirty-four individuals participated in the survey. Clinical evidence and cost effectiveness were deemed to be the most important factors in the process of making purchasing decisions. The most important considerations for adopting new technology were whether there was sufficient evidence in the literature, followed by thoughts of key opinion leaders, and cost of intervention/device. Ongoing research is still needed, but the current study allowed us to identify some trends in the data, providing new insight on how hospital purchasing decisions are made, which could have an immediate impact on those currently involved with making these decisions.

Clinical and Cost Implications of Inpatient Versus Outpatient Orthopedic Surgeries: A Systematic Review of the Published Literature.

The number of outpatient orthopedic surgeries performed within North America continues to increase. The impact of this change in services on patient outcomes is largely unknown. The objective of this review is to compare patient outcomes and associated costs for outpatient orthopedic surgeries traditionally performed in hospital to inpatient surgeries, as well as to summarize the eligibility and preoperative education requirements for outpatient orthopedic surgery in North America. We performed a systematic review of Medline, Pubmed and Embase databases for articles comparing the clinical and economic impact of outpatient orthopedic surgical procedures versus inpatient procedures in North America. We reported on requirements for inpatient versus outpatient care, preoperative education requirements, complications and patient outcomes, patient satisfaction, and when available total mean costs. Nine studies met the inclusion criteria for this review. Eligibility requirements for outpatient orthopedic surgery within the included studies varied, but generally included: patient consent, a caregiver at home following surgery, close proximity to an outpatient center, and no history of serious medical problems. Preoperative education programs were not always compulsory and practices varied between outpatient centers. All of the reviewed studies reported that outpatient surgeries had similar or improved level of pain and rates of nausea. Outpatients reported increased satisfaction with the care they received. As expected, outpatient procedures were less expensive than inpatient procedures. This review found that outpatient procedures in North America appear to be less expensive and safe alternatives to inpatient care for patients who are at lower risk for complications and procedures that do not necessarily require close hospital level care monitoring following same day surgery.

Conflict of interest reporting in dentistry randomized controlled trials: a systematic review.

OBJECTIVES: Conflict of interest (COI) reporting in the medical field has been a concern for a number of years. As the impact of industry on medical research increases, the need for transparency in these relationships increases. In this present study we aim to assess current practices and associations for COI reporting in the field of dentistry. STUDY DESIGN: We conducted a systematic review of conflict of interest reporting for randomized controlled trials (RCTs) in 6 journals of Dentistry published between Jan 2011 and Mar 2012. We extracted study characteristics in duplicate and used descriptive statistics and Chi-square tests to assess associations. RESULTS: Of 1755 studies across seven journals, we identified 66 eligible RCTs. Many included studies were conducted in Europe (39%), with an average sample size of 355. A total of 76% of studies mentioned the presence or absence of potential COI. No correlation between the direction of results and whether a COI was declared was found (p = 0.328), nor was there an association between funding source and whether COI was discussed (p = 0.120). The journal in which the article was published did however have a correlation as to whether COI was discussed (p ≤ 0.0001). CONCLUSIONS: RCTs published in the field of dental research inconsistently report the presence or absence of a conflict of interest. Dental journals should standardize conflict of interest reporting to aid dental researchers in understanding when a conflict of interest exists, and to provide transparency to readers and patients alike.

Orthopedic surgeons feel that there is a treatment gap in management of early OA: international survey.

PURPOSE: To understand orthopedic surgeons' views, preferences, and awareness on "treatment gap" and various conservative and surgical treatments for early to mid-stage knee osteoarthritis (OA). METHODS: A self-administered questionnaire on the treatment of knee OA was developed in collaboration with orthopedic surgeons with extensive research experience and methodological expertise. The survey was distributed electronically to a group of international orthopedic surgeons and surgical trainees. The data were collected, reviewed, and analyzed using descriptive statistics. RESULTS: One hundred and seventy-three surgeons and surgical trainees completed the survey. The respondents reported that about 58 % of the patients they treat have early to mid-stage knee OA (Kellgren and Lawrence grade I-III). There were significantly higher usage of medications and lower usage of unicompartmental knee arthroplasty (UKA) and total knee arthroplasty (TKA) (P < 0.05) in developing countries than in developed countries. Four of five surgeons (84 %) perceived a need for better treatments for younger (<60 years old) physically active OA patients in which UKA or TKA is not indicated. Most respondents (80 %) would be willing to adjust age/activity threshold for surgery if a procedure was reversible and recovery was minimal. Two of three surgeons (68.4 %) perceived a treatment gap for early knee OA. However, effective treatments for patients within the treatment gap would have substantial positive social, and economic impacts. CONCLUSION: The study suggests an ongoing treatment gap for patients with early knee OA and the need for better evidence to guide practice.

Cost-effectiveness and economic impact of the KineSpring ® Knee Implant System in the treatment for knee osteoarthritis.

PURPOSE: To investigate the cost-effectiveness and economic impact of the KineSpring System in the treatment for knee osteoarthritis in Germany. METHODS: Functional outcome scores of the general German population and knee osteoarthritis (OA) patients under surgical treatments (HTO, UKA and TKA), conservative treatments and treatment with the KineSpring System were used to derive the utility scores for each group. Quality-adjusted life years (QALYs) of each group were estimated using the utility scores. Finally, cost-utility analysis was performed using cost and QALYs data. The economic impact of knee OA in Germany was assessed in terms of annual total direct cost and indirect cost, total diseased population and potential QALYs saved with the KineSpring System. RESULTS: Assuming the durability of 10 years, the cost-utility ratio of the KineSpring System, surgical treatments and conservative treatments compared to no treatment in 2012 was euro>3,402/QALY, euro 4,899/QALY and euro 9,996/QALY, respectively. With even a lesser durability of 5 years, the cost-utility ratio of the KineSpring System maintained superiority over surgical treatments and conservative treatments (euro 7,327/QALY, euro 9,706/QALY and euro 10,467/QALY, respectively). The KineSpring System is a highly cost-effective alternative for knee osteoarthritis compared with the current accepted cost-effective threshold (willingness to pay) of $50,000 US/QALY gained. Our models suggest KineSpring System, if adapted widely could save up to 2.0 ± 0.07 million QALY assuming it has a 5-year durability and save up to 3.9 ± 0.1 million QALY assuming it has a 10-year durability. CONCLUSION: An economic advantage for using the KineSpring System over other surgical and conservative treatments in knee OA patients in Germany is suggested by our model. According to currently accepted cost-effectiveness guidelines, the KineSpring Knee Implant System for knee OA is a cost-effective strategy.

The natural history of knee osteoarthritis: India-based knee osteoarthritis evaluation (iKare): a study protocol.

METHODOLOGY: Multi-center, cross-sectional, observational study. STUDY CENTER(S): Multiple centers in India. NUMBER OF PARTICIPANTS: 1,000. PRIMARY RESEARCH OBJECTIVE: To characterize patients and treatment utilized for orthopedic patients presenting to both private and public hospital centers in India with knee pain and symptoms suggestive of knee arthritis. INCLUSION CRITERIA: All patients 18 years of age or older who present to a recruiting hospital for treatment of knee pain will be eligible for participation. The subjects must be able to understand and complete the questionnaire. EXCLUSION CRITERIA: Patients with total knee replacement, open wound or evidence of recent surgery, or with a current or a history of tumor and/or fracture in the tibial plateau, femoral condyle or patella, in the affected knee are not eligible. STUDY OUTCOMES: This study aims to characterize the following: general demographics of patients presenting with knee pain, severity of knee symptoms at time of presentation, severity of knee pathology at time of presentation, factors associated with the decision to seek medical care, previous treatments and health care contacts, planned treatment, and gaps in treatment perceived by the patient and treating surgeons.

Conservative treatments, surgical treatments, and the KineSpring® Knee Implant system for knee osteoarthritis: a systematic review.

PURPOSE: Knee osteoarthritis (OA) is a disease with a high global burden, and multiple treatment options are available. In the current review we summarize the results of studies that have evaluated treatments of knee OA, and we compare these results with an implantable load absorber called the KineSpring® Knee Implant System. METHODS: We conducted a literature search of systematic reviews on treatment strategies for knee OA. We pooled results for each treatment in three categories: pain, function, and stiffness. Then we compared this data to that available for the KineSpring System. RESULTS: Medications and viscosupplementation show promising initial pain relief for knee OA. Aerobic and resistance training, unicompartmental knee arthroplasty (UKA), and total knee arthroplasty (TKA) showed a reduction in pain scores. High tibial osteotomy (HTO) generally improves pain and function at 6 weeks, but long-term results are lacking. The KineSpring System demonstrated significant improvements from baseline to 24 months, but direct comparative data are lacking. CONCLUSIONS: Evidence for knee OA therapies suggests improved pain, stiffness, and functional outcomes. Additional research is necessary to clearly delineate the advantages of various approaches to guide practice.

Prospective, multi-center, pilot study to evaluate symptom relief in patients with medial knee osteoarthritis (OA) treated with the KineSpring® knee implant for load reduction - the SOAR protocol.

The study described here is designed as a prospective, multicenter, open-label, single-arm pilot study. Eligible subjects with symptomatic osteoarthritis of the medial compartment of the knee will be enrolled in the study and will receive the KineSpring® Knee Implant System. The study population will consist of adult patients between 25 and 80 years of age that have been diagnosed with medial knee osteoarthritis and have failed to improve after at least 6 months of conservative medical treatment. A patient is considered to have a clinically important change in OA pain and function with a minimum improvement of 20% compared to baseline measures. We will collect data on the safety and effectiveness of the KineSpring in patients with primarily unicompartmental medial knee osteoarthritis through 24 months of postoperative follow-up. These data will provide insights on the overall clinical success and safety outcome of KineSpring System.

Treatment preferences of patients with early knee osteoarthritis: a decision board analysis assessing high tibial osteotomy versus the KineSpring® Knee Implant System.

INTRODUCTION: Decision boards can be useful in shared decision making by helping patients and their physicians choose among treatment options. Two surgical treatments for early knee osteoarthritis (OA) are high tibial osteotomy (HTO) and the KineSpring® Knee Implant System. The primary objective of this study was to determine patient preferences between these two treatments using a decision board. METHODS: We developed a decision board that presented information on HTO and the KineSpring System for treating knee OA. First, it was presented to 15 individuals for a pilot test and a "scope test." Then it was presented to 81 individuals who were asked to imagine that they had early to midstage knee OA, and this group was administered a complete a series of questions, including their treatment preference and what they would be willing to pay if they elected to use the KineSpring System. Descriptive statistics were calculated and a chi-squared test was conducted to assess any significant differences in patient preferences based on demographic characteristics. RESULTS: Our pilot test confirmed that most participants (87%) agreed that the decision board was easy to understand and helped them in making a decision. Of 81 respondents, the KineSpring System was preferred by 60% (n = 49). Individuals selecting KineSpring would be willing to pay an average of $2,700 to receive it over HTO. CONCLUSIONS: When provided with treatment options and information, 60% of individuals preferred the KineSpring System over HTO. The decision board was well-received as a useful tool for presenting information.

Cost-effectiveness of unicompartmental knee arthroplasty, high tibial osteotomy, and KineSpring® Knee Implant System for unicompartmental osteoarthritis of the knee.

Osteoarthritis (OA) of the knee is a condition that causes pain and disability. Numerous non-surgical and surgical interventions are available for individuals with OA that result in good pain relief and return of function. The purpose of this economic analysis was to determine the cost-effectiveness of high tibial osteotomy (HTO), unicompartmental knee arthroplasty (UKA) and the KineSpring® Knee Implant System in the treatment of unicompartmental OA of the knee 10 years post-surgery, considering the costs of revisions, conversions, removals, and complications. Estimates of costs and rates of revision, conversion, removal, and complications related to UKA and HTO were obtained from the literature. Internal reports on the KineSpring System were used for calculations on the KineSpring System. The cost-effectiveness of UKA, HTO and the KineSpring System in terms of QALY gained compared to patients without treatment yielded gains of approximately $5150/QALY, $6754/QALY, and $7010/QALY, respectively. Using the accepted standard willingness-to-pay threshold of $50,000 US/QALY gained, the UKA, HTO, and the KineSpring System are economically favorable. Our analysis demonstrates that the KineSpring System, despite a greater initial cost in surgery, has significantly smaller conversion and complication costs compared to UKA and HTO. The 10 years overall expected cost for the KineSpring System ($12,559) is significantly less compared with that of UKA ($17,570) and HTO ($22,825). Future economic analyses regarding this topic should also consider the cost-effectiveness of these procedures on younger, more active individuals who are still working and should take into account productivity loss.