Robotic-arm assisted knee arthroplasty (rKA) has been associated with improved clinical, radiographic, and patient-reported outcomes. There is a paucity of literature, however, addressing its cost effectiveness. In the context of an integrated health system with an insurance plan and single source comprehensive data warehouse for electronic health records and claims data, we present an evaluation of healthcare costs and utilization associated with manual knee arthroplasty (mKA) versus rKA. We also examine the influence of rKA technology on surgeons’ practice patterns. Practice patterns of KA were assessed 18 months before and after introduction of robotic technology in April 2018. For patients also insured through the system's health plan, inpatient costs (actual costs recorded by health system), 90-day postoperative costs (allowed amounts paid by insurance plan), and 90-day postoperative utilization (length of stay, home health care visits, rehabilitation visits) were compared between mKA and rKA patients, stratified by total (TKA) or unicompartmental (UKA) surgery. Linear regression modeling was used to compare outcomes between the two pairs of groups (mKA vs. rKA, for both UKA and TKA). Log-link function and gamma error distribution was used for costs. All analyses were done using SAS statistical software, with p<0.05 considered statistically significant.Introduction
Methods
Osteoarthritis (OA) represents a leading cause of disability and a growing burden on healthcare budgets. OA is particularly vexing for young, active patients who have failed less invasive therapies but are not yet candidates for arthroplasty. Often, patients suffering in this wide therapeutic gap face a debilitating spiral of disease progression, increasing pain, and decreasing activity until they become suitable arthroplasty patients. An implantable load absorber was evaluated for the treatment of medial knee OA in this patient population. Joint overload has been cited as a contributor to OA onset or progression. In response, the KineSpring® System (Moximed, Inc, USA) has been designed to reduce the load acting on the knee. The absorber is implanted in the subcutaneous tissue without violating the joint capsule, thus preserving the option of future arthroplasty. The implant is particularly useful for young, active patients, given the reversibility of the procedure and the preservation of normal flexibility and range of motion. The KineSpring System was implanted in 55 patients, with the longest duration exceeding two years. The treated group had medial knee OA, included younger OA sufferers (range 31–68 years), with a mean BMI > 30kg/m2. Acute implant success, adverse events, and clinical outcomes using validated patient reported outcomes tools were recorded at baseline, post-op, 2 and 6 weeks, and 3, 6, 12 and 24 months post-op. All patients were successfully implanted with a mean procedure time of 76.4 min (range 54–153 minutes). Mean hospital length of stay was 1.7 days (range 1–3 days), and patients recovered rapidly, achieving full weight bearing within 1–2 wks and normal range of motion by 6 weeks. Most patients experienced pain relief and functional improvement with 85% (35/41) reporting none or mild pain on the WOMAC pain subscale and 90% (37/41) reporting functional impairment as none on mild on the WOMAC function subscale at the latest follow-up visit (mean 9.3 ± 3.5 months). Clinically meaningful and statistically significant pain reduction and functional improvement were noted with baseline WOMAC pain scores (0–100 scale) improving from 42.4 to 16.1 (p<0.001) and WOMAC function (0–100 scale) improving from 42.0 to 14.7 (p<0.001) at latest follow-up. Patients reported satisfaction with the implant and its appearance.Introduction
Methods and Results
Joint load reduction is effective for alleviating OA pain. Treatment options for joint unloading include braces and HTO, both of which may be impractical for patients. The purpose of the present study was to examine the biomechanical rationale of a practical, partial unloading implant (KineSpring® System, Moximed) for knee OA. Device durability was tested by cyclically loading bone-implant constructs through simulated use for at least 10 million cycles. Joint load reduction with the implant was quantified by measuring changes in medial and lateral knee compartment loads generated by cadaver knees in simulated gait. Safety of the device was tested by 3, 6, and 12 month follow-up of implants in an in vivo ovine model. Surgical technique and device safety and efficacy were assessed in human clinical studies. The unloader device survived over 15 million cycles of simulated use without failure. In the simulated gait cadaver model, the unloading device significantly reduced medial compartment (29 ± 13 lbs, p<0.05) and overall knee joint loads during the stance phase of gait testing but did not significantly increase lateral compartment loading. Chronic ovine implants demonstrated good tolerance of the implant with normal wound healing and secure device fixation. Clinical experience (n=49) demonstrated uneventful device implantation. Unlike HTO, the implantation technique for the unloader does not alter joint alignment. This surgical technique avoids removal of bone, ligament, and cartilage, thus preserving future primary arthroplasty, if required. Early-term clinical experience also demonstrates good outcomes for patients, the earliest of whom are beyond 2.6 years with the implant. This unloading device offers a practical and attractive treatment option for patients with medial knee OA: load reduction without load transfer, durability, preservation of downstream treatment options, safety, and early-term efficacy.
The UK and Australian clinical experience of an implantable load absorber was reviewed for knee OA patients who have exhausted conservative care, but are not ideal candidates for HTO or arthroplasty due to age, activity level, obesity, or disinclination. The load absorber was implanted in 58 patients, with the longest duration exceeding two years. Patients included younger OA sufferers (31-68 years), and had a mean BMI > 30kg/m2. Early surgical experience and adverse events with the device were recorded and clinical outcomes using validated patient reported outcomes tools were collected at baseline, post-op, 2 and 6 weeks, and 3, 6, 12 and 24 month timepoints. All patients were successfully implanted with a mean surgical time of 76.4 minutes (range 54-153). After a mean hospital stay of 1.7 days (range 1-3), patients resumed full weight bearing within 1-2 weeks and achieved normal range of motion by 6 weeks. Mean WOMAC pain (0-100 scale) improved from 42.4 to 16.1 (p<0.001); mean WOMAC function (0-100 scale) improved from 42.0 to 14.7 (p<0.001). Most patients reported “no or mild” pain (85%) or “no or mild” functional impairment (90%) at last follow-up (9.5 ± 3.5 months). Patients reported high satisfaction with the implant. Initial UK results mirror the positive Australian experience: reduced pain, improved function, and high satisfaction. Complications arising in the early surgical experience were effectively resolved through revised surgical technique and minor design modifications.Statement of Purpose
Methods and Results
Joint load correlates with knee OA incidence, symptoms, radiographic, morphologic and biological changes. Available load modifying therapies are clinically effective but have drawbacks. The KineSpringTM (Moximed Inc), an investigational device, is designed to reduce compartment loads while avoiding the limitations of current treatments. We compare load reductions of braces, HTO and KineSpringTM. Literature review and experimental data provide compartment load changes for clinically effective knee braces and HTO. Simulated gait testing was completed on four cadaver knees with early-stage OA. Gait was simulated using a cadaver-based kinematic test system that applies motion and loading patterns dynamically to cadaver specimens. Medial and lateral compartment femoro-tibial pressures were measured throughout testing using thin film dynamic pressure sensors (Tekscan, Inc.) placed inframeniscally. Three conditions were tested: no treatment, applied valgus moments to simulate a valgus moment brace, and implanted KineSpring. Sufficient clinical data exists to support the development of new and novel load modifying therapies for knee OA. Joint load reductions provided by HTO and valgus moment braces provide insight into clinically effective load reduction ranges. Opening wedge HTOs of 5° and 10° are reported to reduce average medial compartment load by 55 N (12 lbs) and 286 N (64 lbs), respectively1. Valgus braces were reported to reduce medial compartment loads an average of 97-280 N (22-63 lbs). From this data we propose a clinically effective load reduction range of 55 to 286N is a valid indicator of the likely clinical success for medial knee load reduction treatments. Gait simulation was successfully completed in all specimens in all test configurations. The valgus moment brace reduced medial compartment load by 58 ±20 N but did not reach statistical significance. The Kinespring reduced medial compartment load by 129±64 N in comparison to the untreated case, a statistically significant reduction. Neither the KineSpring nor the valgus moment brace caused significant changes in the lateral compartment during stance. All treatments reduced medial compartment loads. KineSpringTM reduces loads in what we determined to be the clinically effective range. Additional studies and clinical investigations are warranted to determine the ultimate effectiveness of this implant system.
Long bone surgery and marrow instrumentation represent significant surgical insults, and may cause severe local and systemic sequelae following both planned and emergent surgery. Preconditioning is a highly conserved evolutionary endogenous protective mechanism, but finding a clinically safe and acceptable method of induction has proven difficult. Glutamine, a known inducer of the heat shock protein (HSP) response, offers pharmacological modulation of injury through clinically acceptable preconditioning. This effect has not been previously demonstrated in an orthopaedic model. The aim of the study was to test the hypothesis that glutamine preconditioning protects against the local and systemic effects of long bone trauma in a rodent model.Introduction
Aims
Compartment syndrome (CS) is a unique form of skeletal muscle ischaemia. N-acetyl cysteine (NAC) is an anti-oxidant in clinical use, with beneficial microcirculatory effects. Sprague-Dawley rats (n=6/group) were randomised into Control, CS and CS pre-treated with NAC (0.5g/kg i.p. 1 hr prior to induction) groups. In a post-treatment group NAC was administered upon muscle decompression. Cremasteric muscle was placed in a pressure chamber in which pressure was maintained at diastolic minus 10 mm Hg for 3 hours inducing CS, muscle was then returned to the abdominal cavity. At 24 hours and 7 days post-CS contractile function was assessed by electrical stimulation. Myeloperoxidase (MPO) activity was assessed at 24-hours. CS injury reduced twitch (50.4±7.7 vs 108.5±11.5, p<0.001; 28.1±5.5 vs. 154.7±14.1, p<0.01) and tetanic contraction (225.7±21.6 vs 455.3±23.3, p<0.001; 59.7±12.1 vs 362.9±37.2, p<0.01) compared with control at 24 hrs and 7 days respectively. NAC pre-treatment reduced CS injury at 24 hours, preserving twitch (134.3±10.4, p<0.01 vs CS) and tetanic (408.3±34.3, p<0.01 vs CS) contraction. NAC administration reduced neutrophil infiltration (MPO) at 24 hours (24.6±5.4 vs 24.6±5.4, p<0.01). NAC protection was maintained at 7 days, preserving twitch (118.2±22.9 vs 28.1±5.5, p<0.01) and tetanic contraction (256.3±37 vs 59.7±12.1, p<0.01). Administration of NAC at decompression also preserved muscle twitch (402.4±52; p<0.01 versus CS) and tetanic (402.4±52; p<0.01 versus CS) contraction, reducing neutrophil infiltration (24.6±5.4 units/g; p<0.01). These data demonstrate NAC provided effective protection to skeletal muscle from CS induced injury when given as a pre- or post-decompression treatment.
The mechanism by which cells die is important in an immune response and its resolution. The role of apoptosis in sepsis and trauma, and its regulation by cytokines is unclear. During the systemic inflammatory response, rates of human neutrophil apoptosis are decreased. Peritoneal macrophage apoptosis has been induced by nitric oxide and Lipopolysaccharide (LPS) We examined the induction and effects of macrophage apoptosis in a model of trauma and sepsis. One hundred female CD-I mice were randomised into four groups: Control, Septic model, challenged with intraperitoneal LPS (1.Img/200ul/mouse), Traumatic model, received hind limb amputation (HLA) and a Combined trauma/septic model. After 24 hrs mice were sacrificed and peritoneal macrophages were assessed for apoptosis by morphology and DNA fragmentation by flow cytometry and DNA gel electrophoresis Peritoneal lavage from septic models had a decreased percentage of macrophages in comparison to control and trauma groups. The septic model also had a significantly increased incidence of apoptosis in comparison to control and trauma levels. There was no significant difference between control and traumatic groups. These findings demonstrate that in a murine model of sepsis, lipopolysaccharide induces macrophages apoptosis. Modulation of this immune response may have important roles in the management of trauma patients.
Phenytoin has previously been shown to accelerate wound healing through upregulation of angiogenesis and promotion of collagen deposition. These reported effects led us to hypothesise that phenytoin could be used locally at the tendon repair site to increase the rate and strength of healing. Systemic treatment with phenytoin has also been shown to increase the thickness and density of calvarial and maxillary bones in humans, and promote fracture healing in rabbits, rats and mice. Based on these and similar studies we hypothesised that local percutaneous injection of phenytoin solution into a fracture site would result in improved fracture healing without the risk of the side effects of systemic administration of the drug.
For the fracture study, a rat femur fracture model was utilised. Adult male Sprague-Dawley rats were anaesthetised. Following a medial parapatellar approach, the femur was cannulated using an 18 gauge cannula. The cannula was cut flush with the distal femur and countersunk. The skin and retinaculum were closed with 5.0 monocryl. The nailed femur was then fractured using a 3 point bending technique. The femurs were xrayed to ensure each fracture was mid-diaphyseal and transverse. At 6 hours post op animals underwent either 1) Fracture site percutaneous injection with 100 μmol phenytoin solution 2) Fracture site percutaneous injection with phosphate buffer solution (PBS) 3) No percutaneous injection. This procedure was once again repeated at 72 hours. At 2 and 4 weeks post op 6 animals from each group were euthanased, their femurs were harvested for biomechanical analysis of stiffness and strength.
At both 2 and 4 weeks there was no statistical difference in stiffness or strength of the phenytoin treated fractures compared to controls.
Ranitidine’s effect on implant infection rates showed higher rates (44% versus 17%, relative risk 1.8 (95% CI 1.0 to 3.3)) when systemic ranitidine was delivered peri-operatively, suggesting an immunosuppressive effect.
The beneficial effects of insulin in the maintenance of normoglycaemia in non-diabetic myocardial infarct and intensive care patients have recently been reported. Hyperglycaemia and neutrophilia have been shown to be independent prognostic indicators of poor outcome in the traumatised patient. The role of insulin and the maintenance of normoglycaemia in the trauma patient have as yet not been explored. We hypothesised that through the already described anti-inflammatory effects of insulin and the maintenance of normoglycaemia, that neutrophil activation and endothelial dysfunction would be attenuated, in the injured patient. This might result in less adult respiratory distress syndrome (ARDS) and multi-organ dysfunction and therefore less morbidity and mortality for the trauma patient.
Aseptic loosening of implants following hip arthroplasty is a cause of significant patient morbidity. We genotyped 99 revision hip arthroplasty patients and 116 primary hip arthroplasty patients for the C282Y and the H63D mutations, which cause Haemochromatosis. Haemochromatosis is an inherited condition leading to excessive iron absorption and deposition in the body. All patients at the time of their primary hip arthroplasty were diagnosed as having osteoarthritis. We identified 9 of the 99 revision arthroplasty patients as being homozygous for the C282Y mutation. The time to revision in this group was significantly lower (p<
0.005) when compared to the remaining 90 patients in the group (mean 8.7 years vs 14.8 years). Analysis of variables such as patient age and sex and also type of prosthesis, place of surgery and operating surgeon had no confounding influence. We hypothesise that undiagnosed iron overload in the patients homozygous for the C282Y mutation is likely to cause premature failure of their primary hip arthroplasty.