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).

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.

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.

Anterior versus posterior surgical approaches to treat cervical spondylotic myelopathy: outcomes of the prospective multicenter AOSpine North America CSM study in 264 patients.

Study Design: A prospective observational multicenter study.

Objective: To help solve the debate regarding whether the anterior or posterior surgical approach is optimal for patients with cervical spondylotic myelopathy (CSM).

Summary Of Background Data: The optimal surgical approach to treat CSM remains debated with varying opinions favoring anterior versus posterior surgical approaches.

Mild diabetes is not a contraindication for surgical decompression in cervical spondylotic myelopathy: results of the AOSpine North America multicenter prospective study (CSM).

Background Context: Cervical spondylotic myelopathy (CSM) is a chronic spinal cord disease and can lead to progressive or stepwise neurologic decline. Several factors may influence this process, including extent of spinal cord compression, duration of symptoms, and medical comorbidities. Diabetes is a systemic disease that can impact multiple organ systems, including the central and peripheral nervous systems.

Incidence of dysphagia comparing cervical arthroplasty and ACDF.

Study Design: Retrospective cohort from randomized prospective clinical trial.

Objective: Evaluate incidence of dysphagia between instrumented ACDF and a no-profile cervical disc arthroplasty.

Summary Of Background Data: Dysphagia is a well-known complication following anterior cervical discectomy and fusion (ACDF) and the etiology is multifactorial.

Two-Year Results of a Randomized Controlled Clinical Trial Comparing ProDisc-C and Anterior Cervical Discectomy and Fusion.

Background: Anterior cervical discectomy and fusion (ACDF) is a well-accepted procedure for the treatment of cervical radiculopathy. Hilibrand et al. reported that adjacent segment disease is known to occur at a rate of 2.

Sagittal split fractures in multilevel cervical arthroplasty using a keeled prosthesis.

This is a case report of intraoperative sagittal split fractures in multilevel cervical disc replacement using a keeled prosthesis. The patient's clinical course is discussed and outcomes measured with the SF-36 questionnaire, oswestry disability index, and visual analog scale neck pain are compared with the other patients at our institution that have undergone multilevel disc replacement. The patient did well and has not had any complications related to the device used or fractures.