Comparison of Existing and New Total Knee Arthroplasty Implant Systems From the Same Manufacturer: A Prospective, Multicenter Study.

INTRODUCTION: This study evaluated total knee arthroplasty (TKA) outcomes for an Existing-TKA versus New-TKA from the same manufacturer. METHODS: TKA outcomes for 752 with Existing-TKA versus 1129 subjects with New-TKA were followed through 2 years using patient-reported outcome measures (PROMs). Responders were assessed per Outcome Measures in Rheumatology-Osteoarthritis Research Society International criteria. Kaplan-Meier implant survivorship was estimated. Radiographs had an independent radiographic review. RESULTS: Two-year follow-up was 84.6% (636/752) for Existing-TKA and 82.5% (931/1129) for New-TKA. Two-year PROMs mean outcomes for New-TKA versus Existing-TKA at 2 years were: Knee Injury and Osteoarthritis Outcome Score (ADL: 89.0 versus 86.8, P = 0.005; pain: 88.9 versus 87.1, P = 0.019; symptoms: 84.1 versus 82.2, P = 0.017; Sport/Rec: 63.9 versus 58.8, P = 0.001; and QOL: 77.0 versus 73.5, P = 0.003), Patient's Knee Implant Performance (overall: 76.5 versus 73.5, P = 0.003; confidence: 8.4 versus 8.1, P = 0.004; stability: 8.6 versus 8.3, P = 0.006; satisfaction: 8.3 versus 8.1, P = 0.042; and modifying activities: 6.6 versus 6.4, P = 0.334), Oxford Knee Score (41.9 versus 41.1, P = 0.027), and EQ5D-3L (0.88 versus 0.88, P = 0.737). Two-year responder rates using WOMAC were 93.9% versus 90.6% (P = 0.018) for New-TKA versus Existing-TKA. Independent radiographic review showed that tibial and femoral radiolucencies ≥2 mm were similar (P ≥ 0.05) or favored New-TKA. Implant survivorship was similar between groups (log-rank P = 0.9994). DISCUSSION: New-TKA versus Existing-TKA demonstrated slightly better PROMs with similar radiographic and implant survivorship outcomes.

Early outcomes and predictors of patient satisfaction after TKA: a prospective study of 200 cases with a contemporary cemented rotating platform implant design.

PURPOSE: The purpose of the study was to identify the earliest time point where subjects realized the greatest clinical improvement after TKA, and the time when post-operative scores became superior to pre-operative scores. Post-hoc exploratory analyses were conducted to investigate predictors of early post-operative outcomes and patient satisfaction. METHODS: Six investigators across 4 sites in the Netherlands prospectively implanted 200 subjects with a contemporary cemented rotating platform device. Patient Reported Outcome Measurements (PROMs) KOOS-PS, PKIP, and EQ-5D were collected pre-operatively and post-operatively through 2-years. PROMs change from pre-operative baseline were summarized, along with radiographic outcomes and adverse events (AEs). Pre-operative patient characteristics were explored for correlation with patient outcomes, and patient satisfaction for correlation with KOOS-PS. RESULTS: Follow-up compliance was 99% at 6-months, and 95.5% at 2-years. The percentage with higher KOOS-PS compared to baseline was 81.3% at 6-months. KOOS-PS, PKIP, and PKIP subscore means were all better at 6-weeks versus baseline. Gender, BMI, hypertension, and pre-operative KOOS-PS were weakly correlated with 6-week KOOS-PS (multivariate R-squared = 14.1%), but only pre-operative KOOS-PS demonstrated correlation with post-operative KOOS-PS at 6-months or later (R-squared < 5% at 6-months and 2 years). Satisfaction was moderately correlated with concurrent KOOS-PS at each post-operative time point, with (R-squared = 35.3% at 6-months, and 37.5% at 2 years). CONCLUSION: The greatest mean clinical improvement occurred within the first 6-weeks. Although some pre-operative factors were correlated with higher early post-operative KOOS-PS outcomes, these advantages disappeared by 6-months aside from weak correlation with pre-operative KOOS-PS. Post-operative KOOS-PS was moderately correlated with concurrent post-operative satisfaction. These results may be used for pre-operative counseling and management of patient's postoperative expectations. TRIAL REGISTRATION: Clinicaltrials.gov, NCT02339610 . Registered 15 January 2015.

Single Use Instruments for Implanting a Contemporary Total Knee Arthroplasty System Are Accurate, Efficient, and Safe.

BACKGROUND: Single use instruments (SUI) is a potential mechanism to improve efficiency and reduce cost in total knee arthroplasty (TKA). New technology requires patient safety and surgical accuracy. A multi-center study of SUI vs reusable mechanical instrumentation (RUI) for a TKA system compared implant placement accuracy and operating room (OR) efficiency. METHODS: Four surgeons implanted 88 primary TKAs, N = 44 RUI and N = 44 SUI. Accuracy was measured radiographically at 3 months. The primary endpoint was non-inferiority of absolute value of mechanical axis alignment. Radiographic endpoints, OR times, and adverse events were also evaluated. RESULTS: Seventy-five subjects completed the study (41 SUI/34 RUI). The primary endpoint non-inferiority of SUI vs RUI was met, with no significant difference between SUI and RUI in most radiographic parameters (distal femoral varus-valgus, proximal tibial varus-valgus, tibial slope, or subjects within 3° of target); there was a slight difference in femoral component flexion angle (P = .015). SUI and RUI mean (SD) OR set-up times were 18.8 (10.03) and 26.7 (6.93) (P <.001), and surgical times (first incision to last stitch) were 64.6 (16.95) and 60.5 (19.01) (P = .295), respectively. Differences in OR clean-down and anesthesia were not significant. There were no revisions, and there was no significant difference in the number of reported adverse events. CONCLUSION: SUI resulted in similar accuracy of implant placement to RUI with decreased OR set-up time and no increase in adverse events. These results support the safety and efficacy of SUI for performing TKA. Further analysis of potential economic and technical advantages is warranted.

Learning curve with a new primary total knee arthroplasty implant: a multicenter perspective with more than 2000 patients.

BACKGROUND: This study provides an example for evaluating learning curve when introducing a new knee system. METHODS: Thirty-five investigators across 22 sites prospectively implanted 843 subjects with currently available products (group A). Seventy-seven investigators across 48 sites prospectively implanted 2330 subjects with the ATTUNE Knee System; in which the first 10 subjects for each surgeon were the learning curve cases (group B, N = 611), and the later subjects were designated as group C (N = 1719). Surgical time, rates of intraoperative and early postoperative complications, and patient-reported outcome measures (PROMs) at a minimum of 1 year were compared. RESULTS: Mean (standard deviation) surgical time was 72.0 (21.6) minutes for group A, 83.0 (24.2) for group B, and 72.1 (24.1) for group C (P < .001 for group B vs group C; P = .955 for group C vs group A). Intraoperative, early (<90 day) complication rates, and PROMs were similar for all groups. CONCLUSIONS: The new knee system learning curve was characterized by a slightly longer surgical time with no negative impact on complications or PROMs. LEVEL OF EVIDENCE: III.

Comparative Incidence of Patellofemoral Complications Between 2 Total Knee Arthroplasty Systems in a Multicenter, Prospective Clinical Study.

BACKGROUND: Cumulative incidence rates (CIRs) of patellofemoral complications (PCCs) and patellofemoral symptomatic crepitus (SC) using a new knee system-total knee arthroplasty (NEW-TKA) were compared with those of a currently available product-total knee arthroplasty (CA-TKA). METHODS: Twenty-two investigators prospectively enrolled 704 patients into a study using CA-TKA; 364 received a posterior-stabilized configuration. Twenty-three investigators (19 from the CA-TKA study) enrolled 1138 patients with NEW-TKA; 584 received a posterior-stabilized configuration. CIRs were estimated with Kaplan-Meier methods. RESULTS: CA-TKA had 32 PCCs (6.15% CIR at 1 year and 8.26% at 2 years). NEW-TKA had 19 PCCs (3.15% CIR at 1 year and 4.11% at 2 years). CA-TKA had 15 SCs, 12 before 2 years (CIR = 3.67%); NEW-TKA had 5 SCs before 2 years (CIR = 1.21%). NEW-TKA had a statistically lower CIR of overall PCC and SC (log-rank P values = .018 for PCC and .017 for SC). CONCLUSION: Interim 1- and 2-year CIRs of PCC and SC in NEW-TKA were less than half of those for CA-TKA, which is a promising trend for this new implant.

Midterm Results of Delta Ceramic-on-Ceramic Total Hip Arthroplasty.

This study reports mid-term results of Delta ceramic on ceramic (COC) in total hip arthroplasty (THA). Subjects received Delta COC THA in a prospective multi-center study with either 28 mm (n=177) or 36 mm (n=168) articulations. Annual clinical and radiographic evaluations were performed, and patients were asked about hip noises. At mean 5.3-year follow-up there were 3 (0.9%) post-operative liner fractures. Nine revisions were performed (2 liner fracture, 4 stem loosening, 3 deep infection). Kaplan-Meier survivorship at 6 years was 96.9% (94.0-98.4). Twenty-six (7.5%) subjects reported squeaking, of whom none were revised. One (0.3%) subject could reproduce a sound in clinic. More patients reported squeaking with a 36 mm bearing (28 mm: 7/177, 36 mm: 19/168, P=0.013).

Effect of a balloon-expandable intracranial stent vs medical therapy on risk of stroke in patients with symptomatic intracranial stenosis: the VISSIT randomized clinical trial.

IMPORTANCE: Intracranial stenosis is one of the most common etiologies of stroke. To our knowledge, no randomized clinical trials have compared balloon-expandable stent treatment with medical therapy in symptomatic intracranial arterial stenosis. OBJECTIVE: To evaluate the efficacy and safety of the balloon-expandable stent plus medical therapy vs medical therapy alone in patients with symptomatic intracranial stenosis (≥70%). DESIGN, SETTING, AND PATIENTS: VISSIT (the Vitesse Intracranial Stent Study for Ischemic Stroke Therapy) trial is an international, multicenter, 1:1 randomized, parallel group trial that enrolled patients from 27 sites (January 2009-June 2012) with last follow-up in May 2013. INTERVENTIONS: Patients (N = 112) were randomized to receive balloon-expandable stent plus medical therapy (stent group; n = 59) or medical therapy alone (medical group; n = 53). PRIMARY OUTCOME MEASURE: a composite of stroke in the same territory within 12 months of randomization or hard transient ischemic attack (TIA) in the same territory day 2 through month 12 postrandomization. A hard TIA was defined as a transient episode of neurological dysfunction caused by focal brain or retinal ischemia lasting at least 10 minutes but resolving within 24 hours. Primary safety measure: a composite of any stroke, death, or intracranial hemorrhage within 30 days of randomization and any hard TIA between days 2 and 30 of randomization. Disability was measured with the modified Rankin Scale and general health status with the EuroQol-5D, both through month 12. RESULTS: Enrollment was halted by the sponsor after negative results from another trial prompted an early analysis of outcomes, which suggested futility after 112 patients of a planned sample size of 250 were enrolled. The 30-day primary safety end point occurred in more patients in the stent group (14/58; 24.1% [95% CI, 13.9%-37.2%]) vs the medical group (5/53; 9.4% [95% CI, 3.1%-20.7%]) (P = .05). Intracranial hemorrhage within 30 days occurred in more patients in the stent group (5/58; 8.6% [95% CI, 2.9%-19.0%]) vs none in the medical group (95% CI, 0%-5.5%) (P = .06). The 1-year primary outcome of stroke or hard TIA occurred in more patients in the stent group (21/58; 36.2% [95% CI, 24.0-49.9]) vs the medical group (8/53; 15.1% [95% CI, 6.7-27.6]) (P = .02). Worsening of baseline disability score (modified Rankin Scale) occurred in more patients in the stent group (14/58; 24.1% [95% CI, 13.9%-37.2%]) vs the medical group (6/53; 11.3% [95% CI, 4.3%-23.0%]) (P = .09).The EuroQol-5D showed no difference in any of the 5 dimensions between groups at 12-month follow-up. CONCLUSIONS AND RELEVANCE: Among patients with symptomatic intracranial arterial stenosis, the use of a balloon-expandable stent compared with medical therapy resulted in an increased 12-month risk of added stroke or TIA in the same territory, and increased 30-day risk of any stroke or TIA. These findings do not support the use of a balloon-expandable stent for patients with symptomatic intracranial arterial stenosis. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00816166.

Selective patellar resurfacing in total knee arthroplasty: a prospective, randomized, double-blind study.

350 knees were evaluated in a prospective, randomized, double-blinded study of selective patellar resurfacing in primary total knee arthroplasty. Knees with exposed bone on the patellar articular surface were excluded. 327 knees were evaluated at a mean follow-up of 7.8years. 114 knees followed for greater than 10 years were analyzed separately. Satisfaction was higher in patients with a resurfaced patella. In patients followed for at least 10 years, no significant difference was found. No difference was found in KSS scores or survivorship. No complications of patellar resurfacing were identified. The vast majority of patients with remaining patellar articular cartilage do very well with total knee arthroplasty regardless of patellar resurfacing. Patient satisfaction may be slightly higher with patellar resurfacing.

Large-diameter modular metal-on-metal total hip arthroplasty: incidence of revision for adverse reaction to metallic debris.

Large-diameter modular metal-on-metal (MOM) total hip arthroplasty (THA) may offer reduction in wear debris and improved stability. Four studies are summarized here that used a large-diameter modular MOM system. A total of 1076 THAs were performed. This article presents data from 779 of these THAs with minimum 2-year follow-up (mean, 4.2 years) or revision since index THA (21 hips, with 1 more pending). Overall survivorship at 2 years was 98.6%; at 5 years, it was 97.0%. Seven revisions for an adverse reaction to metallic debris (ARMED), and 1 additional pending revision for ARMED, showed marked variability in presenting symptoms and intraoperative and postoperative findings. Data show good clinical performance of the modular MOM system, but suggest that surgeons must be diligent in monitoring MOM THA patients and aggressive in diagnosing and revising patients with a potential ARMED.

Acute hospital costs after minimally invasive versus open lumbar interbody fusion: data from a US national database with 6106 patients.

STUDY DESIGN: Retrospective multi-institutional database review. OBJECTIVE: To determine if minimally invasive interbody fusion is associated with cost savings when compared with open surgery. SUMMARY OF BACKGROUND DATA: Minimally invasive spine (MIS) surgeries are increasingly recognized as equivalent to open procedures. Although these techniques have been advocated for reducing pain, disability, and length of hospitalization, to date there has been little data demonstrating these benefits. METHODS: This study analyzed inpatient hospital records from the Premier Perspective database (2002 to 2009), including patients who underwent a posterior lumbar fusion with interbody cage placement by ICD-9 code, and had implant charge codes that allowed determination if MIS pedicle screws were utilized. Exclusion criteria included a refusion surgery, deformity, >2 levels, and anterior fusion. Total costs were adjusted for covariates (age, sex, race, hospital geography and setting, payor, and comorbidities) using an analysis of covariance model. RESULTS: A total of 6106 patients were identified (1667 MIS and 4439 open). Length of stay (LOS) for 1-level MIS surgery averaged of 3.35 days versus 3.6 days for open surgery (P≤0.006). For 2-level MIS surgery LOS averaged of 3.4 days versus 4.03 days for open surgery (P≤0.001). Total inflation-adjusted acute hospitalization cost averaged $29,187 for 1-level MIS procedures versus $29,947 for open surgery, a nonsignificant difference (P=0.55). Total inflation-adjusted acute hospitalization cost averaged $2106 lower for 2-level MIS surgery (total costs of $33,879 for MIS vs. $35,984 for open surgery, P=0.0023). Cost savings were attributable primarily to lower room and board ($857), operating room ($359), pharmacy ($304), and laboratory ($166) costs in the MIS group. High variances in the 2-level open surgery with prolonged hospital stay also accounted for overall cost differences. CONCLUSIONS: This data from a large nationwide sample of hospitalizations demonstrates that MIS lumbar interbody fusion results in a statistically significant reduction in hospital LOS and a reduction in total hospital costs with 2-level surgery after adjusting for significant covariates. The majority of cost savings from MIS surgery were due to more rapid mobilization and discharge, as well as a reduction in outliers with extended hospitalizations.