Six-Year Follow-up of a Randomized Controlled Trial of i-FACTOR Peptide-Enhanced Bone Graft Versus Local Autograft in Single-Level Anterior Cervical Discectomy and Fusion.

Background: Previous analyses of the US Food and Drug Administration (FDA) Investigational Device Exemption study demonstrated the superiority of i-FACTOR compared with local autograft bone in single-level anterior cervical discectomy and fusion (ACDF) at 12 and 24 months postoperatively in a composite end point of overall success.

Objective: To report the final, 6-year clinical and radiological outcomes of the FDA postapproval study.

Methods: Of the original 319 subjects enrolled in the Investigational Device Exemption study, 220 participated in the postapproval study (106 i-FACTOR and 114 control).

Better Functional Recovery After Single-Level Compared With Two-Level Posterolateral Lumbar Fusion.

Background Multiple studies describe the outcomes of patients undergoing single-level and multilevel posterolateral lumbar fusion (PLF). However, a comparison of outcomes between single-level and two-level PLF is lacking. The aim of this prospective cohort study was to compare outcomes between single-level and two-level instrumented PLF.

Using an asymmetric crosslinked polyethylene liner in primary total hip arthroplasty is associated with a lower risk of revision surgery : an analysis of the National Joint Registry.

Aims: The aim of our study was to investigate the effect of asymmetric crosslinked polyethylene liner use on the risk of revision of cementless and hybrid total hip arthroplasties (THAs).

Methods: We undertook a registry study combining the National Joint Registry dataset with polyethylene manufacturing characteristics as supplied by the manufacturers. The primary endpoint was revision for any reason.

Mid-term outcomes of the R3™ delta ceramic acetabular system in total hip arthroplasty.

Background: Whilst bony fixation of hip replacement has stable solutions, there remains controversy over which bearing best optimizes longevity and function. Ceramic-on-ceramic (CoC) bearing combinations are associated with lower risk of revision due to aseptic loosening and dislocation. Evidence for long-term functional outcomes of modern, 4th generation CoC bearings is limited.

Safety and efficacy of riluzole in patients undergoing decompressive surgery for degenerative cervical myelopathy (CSM-Protect): a multicentre, double-blind, placebo-controlled, randomised, phase 3 trial.

Background: Degenerative cervical myelopathy represents the most common form of non-traumatic spinal cord injury. This trial investigated whether riluzole enhances outcomes in patients undergoing decompression surgery for degenerative cervical myelopathy.

Methods: This multicentre, double-blind, placebo-controlled, randomised, phase 3 trial was done at 16 university-affiliated centres in Canada and the USA.

Effect of Bearing Surface on Survival of Cementless and Hybrid Total Hip Arthroplasty: Study of Data in the National Joint Registry for England, Wales, Northern Ireland and the Isle of Man.

Background: Modern bearing surface options have increased implant survivorship after total hip arthroplasty (THA). We utilized data from the National Joint Registry for England, Wales, Northern Ireland and the Isle of Man (NJR) to analyze implant survivorship after THAs with uncemented acetabular components with different bearing combinations.

Methods: Polyethylene (PE) manufacturing properties supplied by the manufacturers were used to subdivide the NJR data set into cross-linked PE (XLPE) and conventional PE groups.

A higher degree of polyethylene irradiation is associated with a reduced risk of revision for aseptic loosening in total hip arthroplasties using cemented acetabular components: an analysis of 290,770 cases from the National Joint Registry of England, Wales, Northern Island and the Isle of Man.

Aims: To investigate the effect of polyethylene manufacturing characteristics and irradiation dose on the survival of cemented and reverse hybrid total hip arthroplasties (THAs).

Methods: In this registry study, data from the National Joint Registry of England, Wales, Northern Ireland and the Isle of Man (NJR) were linked with manufacturing data supplied by manufacturers. The primary endpoint was revision of any component.

Two-Year Clinical and Radiological Outcomes in Patients With Diabetes Undergoing Single-Level Anterior Cervical Discectomy and Fusion.

Study Design: Secondary analysis of data from the multicenter, randomized, parallel-controlled Food and Drug Administration (FDA) investigational device exemption study.

Objective: Studies on outcomes following anterior cervical discectomy and fusion (ACDF) in individuals with diabetes are scarce. We compared 24-month radiological and clinical outcomes in individuals with and without diabetes undergoing single-level ACDF with either i-FACTOR or local autologous bone.

Polyethylene manufacturing characteristics have a major effect on the risk of revision surgery in cementless and hybrid total hip arthroplasties.

Aims: The aim of this study was to identify the effect of the manufacturing characteristics of polyethylene acetabular liners on the survival of cementless and hybrid total hip arthroplasty (THA).

Methods: Prospective cohort study using linked National Joint Registry (NJR) and manufacturer data. The primary endpoint was revision for aseptic loosening.

The Impact of Older Age on Functional Recovery and Quality of Life Outcomes after Surgical Decompression for Degenerative Cervical Myelopathy: Results from an Ambispective, Propensity-Matched Analysis from the CSM-NA and CSM-I International, Multi-Center Studies.

Background: The effect on functional and quality of life (QOL) outcomes of surgery in elderly degenerative cervical myelopathy (DCM) patients has not been definitively established.

Objective: To evaluate the effect of older age on the functional and QOL outcomes after surgery in an international, multi-center cohort of patients with DCM.

Methods: 107 patients aged over 70 years old (mean 75.

Midterm Performance of a Guided-Motion Bicruciate-Stabilized Total Knee System: Results From the International Study of Over 2000 Consecutive Primary Total Knee Arthroplasties.

Background: The JOURNEY II Bi-Cruciate Stabilizing Total Knee System (BLINDED) is a second-generation guided-motion knee implant that has been used in over 100,000 primary total knee arthroplasties (TKAs) worldwide. However, performance information is limited.

Methods: Data for 2059 primary TKAs were abstracted at 7 US and 3 European sites.

Is Preoperative Duration of Symptoms a Significant Predictor of Functional Outcomes in Patients Undergoing Surgery for the Treatment of Degenerative Cervical Myelopathy?

Background: Preoperative duration of symptoms may significantly impact outcomes in patients treated surgically for degenerative cervical myelopathy (DCM).

Objective: To (i) analyze whether duration of symptoms is associated with preoperative functional impairment, disability, and quality of life and (ii) determine the optimal timing for decompressive surgery.

Methods: Patients with DCM were prospectively enrolled in either the AOSpine North American or International study at 26 global sites (n = 757).

Second-generation bi-cruciate stabilized total knee system has a lower reoperation and revision rate than its predecessor.

Introduction: Total knee arthroplasty (TKA) can provide pain relief and good long-term results. However, nearly 30% of post-surgical patients are unsatisfied due to persistent pain and functional deficits. A second-generation bi-cruciate stabilized TKA device has a post-cam mechanism with an asymmetric femoral component, a polyethylene insert, and a medially concave and laterally convex shape.

Predictive factors of survival in a surgical series of metastatic epidural spinal cord compression and complete external validation of 8 multivariate models of survival in a prospective North American multicenter study.

Background: This study was designed to identify preoperative predictors of survival in surgically treated patients with metastatic epidural spinal cord compression (MESCC), to examine how these predictors are related to 8 prognostic models, and to perform the first full external validation of these models in accordance with the Transparent Reporting of a Multivariable Prediction Model for Individual Prognosis or Diagnosis (TRIPOD) statement.

Methods: One hundred forty-two surgically treated patients with MESCC were enrolled in a prospective, multicenter North American cohort study and were followed for 12 months or until death. Cox regression was used.

Short-term safety and effectiveness of a second-generation motion-guided total knee system.

Background: Modern knee prostheses are designed to more closely replicate normal knee kinematics. The JOURNEY II Bi-Cruciate Stabilized Total Knee System (Smith & Nephew Inc., Memphis, TN) is a second-generation motion-guided knee system that demonstrates axial rotation patterns during flexion, which resemble those of the normal knee.

i-Factor™ Bone Graft vs Autograft in Anterior Cervical Discectomy and Fusion: 2-Year Follow-up of the Randomized Single-Blinded Food and Drug Administration Investigational Device Exemption Study.

Background: i-Factor™ Bone Graft (Cerapedics Inc, Westminster, Colorado) is a composite bone substitute material consisting of P-15 synthetic collagen fragment adsorbed onto anorganic bone mineral suspended in an inert biocompatible hydrogel carrier. A pivotal, noninferiority, US FDA Investigational Device Exemption study demonstrated the benefits of i-Factor™ compared to local autograft bone in single-level anterior cervical discectomy and fusion at 1-yr postoperative.

Objective: To report 2-yr follow-up.

Geographic variations in clinical presentation and outcomes of decompressive surgery in patients with symptomatic degenerative cervical myelopathy: analysis of a prospective, international multicenter cohort study of 757 patients.

Background Context: Degenerative cervical myelopathy (DCM) is a progressive degenerative spine disease and the most common cause of spinal cord impairment in adults worldwide. Few studies have reported on regional variations in demographics, clinical presentation, disease causation, and surgical effectiveness.

Purpose: The objective of this study was to evaluate differences in demographics, causative pathology, management strategies, surgical outcomes, length of hospital stay, and complications across four geographic regions.

Risk Factors for and Clinical Outcomes of Dysphagia After Anterior Cervical Surgery for Degenerative Cervical Myelopathy: Results from the AOSpine International and North America Studies.

Background: Although dysphagia is a common complication after anterior cervical decompression and fusion, important risk factors have not been rigorously evaluated. Furthermore, the impact of dysphagia on neurological and quality-of-life outcomes is not fully understood. The aim of this study was to determine the prevalence of and risk factors for dysphagia, and the impact of this complication on short and long-term clinical outcomes, in patients treated with anterior cervical decompression and fusion.

Surgery for degenerative cervical myelopathy: a patient-centered quality of life and health economic evaluation.

Background Context: Degenerative cervical myelopathy (DCM) represents the most common cause of non-traumatic spinal cord impairment in adults. Surgery has been shown to improve neurologic symptoms and functional status, but it is costly. As sustainability concerns in the field of health care rise, the value of care has come to the forefront of policy decision-making.

Laminectomy and fusion versus laminoplasty for the treatment of degenerative cervical myelopathy: results from the AOSpine North America and International prospective multicenter studies.

Background Context: It remains unclear whether cervical laminoplasty (LP) offers advantages over cervical laminectomy and fusion (LF) in patients undergoing posterior decompression for degenerative cervical myelopathy (DCM).

Purpose: The objective of this study is to compare outcomes of LP and LF.

Study Design/setting: This is a multicenter international prospective cohort study.

Psychometric properties of the 30-m walking test in patients with degenerative cervical myelopathy: results from two prospective multicenter cohort studies.

Background Context: The timed 30-m walking test (30MWT) is used in clinical practice and in research to objectively quantify gait impairment. The psychometric properties of 30MWT have not yet been rigorously evaluated.

Purpose: This study aimed to determine test-retest reliability, divergent and convergent validity, and responsiveness to change of the 30MWT in patients with degenerative cervical myelopathy (DCM).