Indiana Orthopaedic Hospital

Patellofemoral instability (PFI) is common in adolescents and may require surgical treatment. Patient-reported outcome scores (PROs) are frequently used to evaluate outcomes after treatment. Commonly used PROs for PFI include disease-specific Banff Patellofemoral Instability Instrument 2.0 (BPII 2.0) and region-specific measures such as the Kujala Anterior Knee Pain Scale (Kujala), Pediatric International Knee Documentation Committee Subjective Knee Form (Pedi-IKDC), and Knee injury and Osteoarthritis Outcome Score (KOOS). The study aimed to compare the performance of disease-specific and region-specific PROs in adolescents after PFI surgery, and to evaluate their sensitivity to change. It was hypothesized that disease-specific PROs would perform better than region-specific PROs. Case series; Level of evidence, 4. The JUPITER (Justifying Patellar Instability Treatment by Early Results) study database was used to evaluate PROs in 256 adolescents (263 knees) aged ≤18 years who underwent surgical treatment for PFI. Four commonly used PRO scores were analyzed at baseline and at least 1 year postoperatively. Statistical analysis included comparisons between pre- and postoperative scores, calculation of minimal clinically important difference (MCID), correlations among the 4 scores, and evaluation of their sensitivity to change, floor effects, and ceiling effects. The median age was 15 years. Isolated medial patellofemoral ligament reconstruction was the most common procedure. The mean BPII 2.0 scores were lower at baseline and postoperatively, and showed the most substantial change at 1-year follow-up. There was a moderate correlation between the BPII 2.0 and the Kujala, Pedi-IKDC, and KOOS scores, and a strong correlation among the latter 3 scores. All scores were more sensitive to change among those at the lower 50th percentile of baseline scores. The BPII 2.0 was the only PRO that did not exhibit ceiling effects at follow-up. When comparing the performance of disease-specific (BPII 2.0) and region-specific (Kujala, Pedi-IKDC, and KOOS) PROs, the BPII 2.0 was found to be the most sensitive to change after PFI surgery in adolescents, and the only scale that did not have a ceiling effect at baseline and 1-year follow-up. There was a moderate correlation-and thus limited interchangeability-between the BPII 2.0 and the Kujala, Pedi-IKDC, and KOOS scores, both at baseline and at 1-year follow-up, and a strong correlation among the latter 3 knee-specific PROs. The BPII 2.0 should be considered the PRO of choice when evaluating adolescent patients with PFI.

Prospective, multicenter, single-blind, randomized, controlled pivotal study. To evaluate whether P-15L (PearlMatrix P-15 Peptide Enhanced Bone Graft) is noninferior in effectiveness to local autograft when applied in single-level instrumented transforaminal lumbar interbody fusion (TLIF). P-15L, an FDA-designated Breakthrough Drug-Device, is a composite drug-device combination bone graft containing P-15, a 15-amino acid polypeptide, which enhances cell binding, proliferation, and differentiation, resulting in bone formation. Skeletally mature patients, aged 22 to 80 years, with degenerative disc disease (DDD) were randomized 1:1 to P-15L (investigational) or to the local autograft (control) during single-level TLIF with a polyetheretherketone (PEEK) cage and supplemental pedicle screw fixation. The primary outcome was composite clinical success (CCS) at 24 months, defined as: no index level secondary surgical procedures; achievement of fusion; ≥15-point improvement in Oswestry low back pain disability questionnaire (ODI) from baseline; no new or worsening persistent neurological deficit relative to baseline; and no device-related serious adverse events (SAEs). A total of 290 patients were enrolled at 33 sites: 141 (48.6%) received P-15L, and 149 (51.3%) received local autograft. P-15L was noninferior ( P <0.0001) and superior ( P =0.002) to autograft with respect to CCS, with 55.5% of the investigational group achieving composite clinical success compared with 37.5% of the control group. P-15L had a 25.8% higher fusion rate as compared with autograft for the CCS at 24 months (84.3% vs. 58.5%, respectively). Device-related SAE rates were similar in both groups. P-15L was superior to local autograft in achieving clinical success at 24 months. Furthermore, P-15L produced a significantly higher fusion rate as compared with autograft. No meaningful clinical differences were found in the incidence of device-related SAEs. P-15L appears to be a safe and effective option for TLIF. Level I.

Study Design.Prospective, multicenter, single-blind, randomized, and controlled pivotal study.Objective.Compare time-to-fusion in patients treated with P-15L (PearlMatrixTM P-15 peptide enhanced bone graft) versus local autograft over 24 months and evaluate changes in pain and quality of life at 24 months relative to baseline.Summary of Background Data.P-15L, an FDA-designated breakthrough device, is a composite bone graft with P-15, a 15-amino acid polypeptide that promotes cellular adhesion, proliferation, and differentiation to support bone formation.Methods.Patients (22–80 y) with degenerative disc disease were randomized to the investigational (P-15L) or control (local autograft) group during single-level transforaminal lumbar interbody fusion (TLIF) with a PEEK cage and supplemental pedicle screw fixation. Fusion assessments occurred at 6, 12, and 24 months. Time-to-fusion was tested for superiority as compared with the control using Kaplan-Meier survival analysis. Back and leg pain were measured using the Visual Analog Scale (VAS) and quality of life was assessed using the Short Form Survey (SF-12).Results.The analysis included 290 patients from 33 sites; 141 (48.6%) received P-15L and 149 (51.3%) received local autograft. At randomization, at least one risk factor for pseudoarthrosis (obesity, nicotine use, or diabetes) was reported in 58.9% (83/141) of the investigational group and 60.4% (90/149) of the control group. More patients in the investigational group than the control group achieved fusion at 6 months (Kaplan-Meier fusion rates 57.6% vs. 26.9%, respectively), 12 months (68.8% vs. 41.5%, respectively), and 24 months (81.1% vs. 54.9%, respectively). P-15L was statistically superior to autograft for time-to-fusion (hazard ratio=1.87, 95% CI: 1.47–2.38; P < 0.0001). There was marked improvement in VAS and SF-12 relative to baseline in both groups at 24 months.Conclusion.P-15L promotes statistically superior earlier time-to-fusion than local autograft in instrumented TLIF. Both treatments resulted in clinically meaningful improvements in pain and quality of life at 24 months.Level of Evidence.Level I.

BackgroundMultifidus muscle may be reflexively inhibited by painful co-existing structural degenerative features, affecting spinal loading and control in patients with chronic low back pain (cLBP). This study aimed to investigate the relationship between magnetic resonance imaging (MRI) features of lumbar spine degeneration and their influence on clinical outcomes of multifidi neurostimulation for cLBP.MethodsThis is a secondary analysis of a Food and Drug Administration (FDA) randomized controlled trial testing the efficacy of an implantable neurostimulator targeting the L2 dorsal rami medial branch nerves innervating the deep multifidi in 204 subjects. Degenerative anatomical features of the lumbar discs, vertebrae, facets, and paraspinal muscles were graded using standardized criteria. Patient-reported outcomes (PROs), including visual analog scale (VAS), Oswestry Disability Index (ODI), and the five-level version of the EuroQol five-dimensional descriptive system (EQ-5D-5L), were collected at baseline, 12, and 24 months. Mixed-design analysis of variance (ANOVA) and post hoc pairwise t-tests were performed to evaluate changes in outcomes in relation to individual demographic variables and MRI features.ResultsIncluded 204 subjects [110 females, 94 males; age: mean ± standard deviation (SD) =47±9 years; body mass index (BMI): mean ± SD =28±4 kg/m2] at baseline had, on average, cLBP for 14±11 years, average VAS of 7.3±0.7 cm, ODI of 39.1±10.3 points, EQ-5D-5L of 0.585±0.174, and mean percentage of days with cLBP in the year before enrollment was 97%±8%. In comparing PRO responses with MRI features, there was no significant finding (P>0.05) explaining improvements in pain, disability, and quality of life for subjects with multifidus atrophy and fatty infiltration, facet arthropathy, disc herniation, annular tears, Modic changes, or lumbar degenerative disc disease. Mixed-design ANOVA revealed statistically significant pre- to post-implantation differences for VAS and ODI for patients with stable, grade I spondylolisthesis (P=0.009, np2=0.031 and P=0.040, np2=0.021). Differences for those with stable, grade I spondylolisthesis were statistically significant and clinically relevant at 12 months in VAS, ODI, and EQ-5D-5L (P=0.006, P=0.040, P<0.001; Cohen’s d =0.539, d =0.396, d =−0.689) and these comparative improvements remained significant for ODI and EQ-5D-5L at 24 months (P=0.03 and P=0.02; Cohen’s d =0.420, d =−0.441).ConclusionsResults indicate that, in a population of cLBP patients, existing lumbar spinal degeneration did not influence the effect of the neurostimulation therapy on PROs. Thus, the presence of mild and moderate lumbar spinal degeneration does not appear to be a contraindication for implantable multifidus neurostimulation, including patients with grade I spondylolisthesis.

Persistent concerns remain about the deleterious pathological effects of minimally invasive transannular puncture, such as occurs during discography and therapeutic intradiscal procedures. The objective of this study was to estimate the safety profile associated with fluoroscopically guided intradiscal delivery of nucleus pulposus (NP) allograft under clinical trial and real-world conditions. This was a retrospective pooled analysis of adverse events (AEs) and clinical complaints captured from 4 different treatment populations (n = 392) and a database of commercial cases (n = 19,392 discs treated) with lumbar discogenic pain who underwent minimally invasive intradiscal NP allograft supplementation. All AEs were graded for severity as mild, moderate, or severe, and relatedness was judged as possibly, probably, or definitely. All serious AEs were adjudicated for outcome. There were 51 total AEs reported across all 4 clinical cohorts, and 6 AEs (12%) were judged to be related to the NP allograft product and the intradiscal procedure, with an additional 4 AEs (8%) related solely to the intradiscal procedure. None of the AEs was associated with infection (ie, discitis), neurological compromise, or escalation to surgical treatment. The product-attributable serious AE incidence was 0.26% (1/392). Of the commercial cases (n = 19,392 discs treated), no clinical AEs were reported from this cohort, with only 101 device complaints (0.521%) related primarily to delivery interface or packaging integrity. Intradiscal NP allograft supplementation for symptomatic degenerative disc disease demonstrates a favorable safety profile. These findings serve to temper concerns about the risk of disc complications and accelerated degeneration following transannular puncture. These findings validate that the NP allograft product and procedure have an exemplary safety profile. As a microinvasive, motion-preserving intervention, this procedure has the potential to bridge the therapeutic gap between conservative care and invasive spine surgery for patients suffering from discogenic back pain.

Depressão representa um importante problema de saúde, pois pode trazer incapacitação. Sua fisiopatologia não é totalmente esclarecida e seu diagnóstico é feito com base nos sintomas persistentes por mais de duas semanas. A vitamina B12 representa um grupo de micronutrientes chamados de cobalaminas e é encontrada exclusivamente em alimentos de origem animal. Tal vitamina tem importante papel na homeostase, participando desde a multiplicação celular (síntese de DNA) a processos de regulação do sistema nervoso central, como o bom funcionamento dos neurotransmissores e mielinização dos neurônios. Sua deficiência se dá principalmente pela má absorção entérica, podendo levar a quadros de anemia, neuropatia, fadiga e declínio cognitivo. A associação deficiência de vitamina B12 e depressão ainda não foi totalmente estabelecida, havendo discordância na literatura. Este estudo teve o intuito de comparar diferentes grupos de participantes que dosaram vitamina B12 e a relação com o uso de antidepressivo, visando estabelecer uma possível relação entre a deficiência de vitamina B12 e a presença de depressão. Para tanto, foram utilizados dados fornecidos por um laboratório de análises clínicas situado no interior do estado de São Paulo. A prevalência encontrada entre aqueles que apresentaram deficiência de vitamina B12, resultado normal ou acima do valor de referência parece não indicar uma relação entre deficiência de cobalamina e uso de antidepressivos. São necessários, portanto, mais estudos para elucidar esse tema ainda obscuro.

Abstract Background: Robotic-assisted technologies have been developed to increase surgical precision and reduce surgical variability in total knee arthroplasty (TKA). Several different robotic systems have been introduced in the last decade for TKA. The DePuy Synthes VELYSTM Robotic-Assisted Solution (VRAS) is an imageless system designed to eliminate the need for preoperative CT scans and is one of the latest entrants in the rapidly evolving field of robotic technology in TKA. This study compared the clinical and economic outcomes associated with VRAS compared to other robotic-assisted technology for primary TKA. Methods: A retrospective cohort study using the Premier Healthcare Database included patients who received their primary TKA with VRAS compared with other robotic-assisted technologies from January 1, 2022, to April 30, 2023. The primary outcome for the study was hospital follow-up visits (revisits) within 90 days post-TKA. Secondary outcomes included readmission and revision rates within 90-day post-TKA, operating room time, length of stay, discharge status and hospital costs. Cohorts were balanced using propensity score fine stratification and generalized linear models were constructed to evaluate outcomes. Results: The study included 827 VRAS TKA cases and 16,428 TKA cases performed with other robotic-assisted technologies. The 90-day all-cause and knee-related revisit rates were statistically significantly lower for VRAS compared to other robotic-assisted technologies (all-cause 13.9% vs. 22.8% and knee-related 2.8% vs. 5.4%, respectively, p-value &lt; 0.01). The all-cause and knee-related 90-day readmission rates were also lower for VRAS though the differences were not statistically significant. 90-day revision rates were similar for VRAS and other robotic-assisted technologies (0.48% vs. 0.45%), as was operating room time (138 vs. 137 minutes). The 90-day knee-related cost for the VRAS cohort was $15,048 compared to $16,867 for other robotic technologies. Conclusions: This database study demonstrates that early post-operative revisit rates and total cost of care is lower for VRAS compared to the class of all other robotic-assisted technologies for TKA, while operating room time and discharge status were similar. These are important findings in ever-evolving healthcare systems which are increasingly cost-conscious and cognizant of principles associated with value-based care.