Orthofix Medical touts data from artificial disc study

Orthofix Medical’s M6-C artificial cervical disc (Image from Orthofix) A study of patients implanted with Orthofix Medical’s (NSDQ:OFIX) M6-C artificial cervical disc showed a significant improvement in neck and arm pain, function and quality of life scores, the company said today. Patients in the investigational device exemption (IDE) study also used less pain and opioid medication when compared with anterior cervical discectomy and fusion (ACDF) patients, and 92% reported they were satisfied with the surgery, the Lewisville, Texas-based business said in a prepared statement. At 24 months, patients in the ACDF group who were still using pain medications had a seven times higher rate of opioid use than those in the M6-C disc group, the study showed. In the M6-C group, 92% reported that were satisfied with the surgery. “The results from the M6-C artificial cervical disc IDE clinical study continue to validate the positive outcomes of cervical disc arthroplasty versus discectomy with fusion,” said Dr. Jack Zigler, an orthopedic spine surgeon at Texas Back Institute and an investigator in the study. “A significant reduction in pain, the maintenance or improvement of neurological function, and the preservation of natural disc motion after 24 months were all meaningful clinical benefits the M6-C disc patients experienced when compared to the fusion control.” Zigler presented the study results during the International Society for the Advancement ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Blog Clinical Trials Featured Food & Drug Administration (FDA) Implants News Well Orthopedics internationalsocietyfortheadvancementofspinesurgery (ISASS) Orthofix Source Type: news

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Study Design. Retrospective cohort study. Objective. The goal of the present study was to determine whether neck pain responds differently to anterior cervical discectomy and fusion (ACDF) between patients with cervical radiculopathy and/or cervical myelopathy. Summary of Background Data. Many patients who undergo ACDF because of radiculopathy/myelopathy also complain of neck pain. However, no studies have compared the response of significant neck pain to ACDF. Methods. Patients undergoing one to three-level primary ACDF for radiculopathy and/or myelopathy with significant (Visual Analogue Scale [VAS] ≥ 3) ne...
Source: Spine - Category: Orthopaedics Tags: CERVICAL SPINE Source Type: research
Conclusions: Irrespective of the BMI, all patients exhibited similar satisfactory outcomes following ACDF. The results support surgery in all subgroups of patients with symptomatic nerve compression in the cervical spine. PMID: 32951406 [PubMed - as supplied by publisher]
Source: Asian Spine Journal - Category: Orthopaedics Tags: Asian Spine J Source Type: research
This study had limited inclusion and exclusion criteria and a well-controlled intervention. It was assumed that both techniques could obtain the similar postoperative effects. Trial registration: This study protocol was registered in Research Registry (researchregistry5878).
Source: Medicine - Category: Internal Medicine Tags: Research Article: Study Protocol Clinical Trial Source Type: research
Study Design. Retrospective analysis of outcomes in single-level spine and primary hip and knee arthroplasty patients. Objective. The aim of this study was to compare baseline and postoperative outcomes in patients undergoing spine surgery procedures with total hip arthroplasty (THA) and total knee arthroplasty (TKA) to further define outcomes in orthopedic surgery. Summary of Background Data. Computer-adaptive Patient Reported Outcome Information System (PROMIS) allows for standardized assessment of the health-related quality of life across different disease states. Methods. Patients who underwent spine surgery...
Source: Spine - Category: Orthopaedics Tags: HEALTH SERVICES RESEARCH Source Type: research
Conclusion. Patients with worse preoperative disability as measured by PROMIS PF reported increased pain but comparable narcotics consumption in the immediate postoperative period following a single-level ACDF procedure. Furthermore, patients experienced similar long-term postoperative improvement of PROs regardless of preoperative physical function. PROMIS PF can efficiently quantify physical function before and after the ACDF procedure as self-evaluated by patients. Level of Evidence: 3
Source: Spine - Category: Orthopaedics Tags: HEALTH SERVICES RESEARCH Source Type: research
Abstract OBJECTIVE: The goal of this study was to evaluate the incidence of pseudarthrosis after the treatment of cervical degenerative disc disease (CDDD) with anterior cervical discectomy and fusion (ACDF) in which self-locking, stand-alone intervertebral cages filled with hydroxyapatite were used. METHODS: The authors performed a retrospective cohort study of 49 patients who underwent 1- to 3-level ACDF with self-locking, stand-alone intervertebral cages without plates, with a minimum 2 years of follow-up. The following data were extracted from radiological and clinical charts: age, sex, time and type of p...
Source: Journal of Neurosurgery.Spine - Category: Neurosurgery Authors: Tags: J Neurosurg Spine Source Type: research
Conclusion. Opioid tolerance was found to be a significant predictor for prolonged opioid use after ACDF. Additionally, opioid-naïve and opioid-tolerant users experienced overall improvements across PROMs following ACDF. Opioid-tolerance was associated with NDI and PCS-12 improvements over time compared to opioid-naïve users. Level of Evidence: 4
Source: Spine - Category: Orthopaedics Tags: CERVICAL SPINE Source Type: research
Abstract OBJECTIVE: The safety and efficacy of anterior and posterior decompression surgery in degenerative cervical myelopathy (DCM) have not been validated in any prospective randomized trial. METHODS: In this first prospective randomized trial, the patients who had symptoms or signs of DCM were randomly assigned to undergo either anterior cervical discectomy and fusion or posterior laminectomy with or without fusion. The primary outcome measures were the change in the visual analog scale (VAS) score, Neck Disability Index (NDI), and Nurick myelopathy grade 1 year after surgery. The secondary outcome measur...
Source: Journal of Neurosurgery.Spine - Category: Neurosurgery Authors: Tags: J Neurosurg Spine Source Type: research
This study compared the surgical outcomes of two surgical methods for treating multilevel cervical spondylotic myelopathy (MCSM) combined with cervical kyphotic deformity (CKD): (1) the ELTA method consisted of expansive open-door laminoplasty (EOLP) followed by three-segment anterior cervical discectomy fusion (ACDF), and (2) the LAPI method consisted of long-segment ACDF followed by long-level posterior instrumented fusion (PIF). Surgical treatment of CKD combined with MCSM remains challenging. Surgical considerations should include adequate spinal cord decompression and restoration of satisfactory cervical sagittal alig...
Source: Medicine - Category: Internal Medicine Tags: Research Article: Observational Study Source Type: research
Conclusion. An early self-directed HEP program was acceptable to patients and has the potential to be safely administered to patients immediately after ACDF. Benefits were noted for short-term neck pain and long-term opioid utilization. However, larger trials are needed to confirm safety with standardized and long-term radiograph assessment and treatment efficacy. Level of Evidence: 2
Source: Spine - Category: Orthopaedics Tags: RANDOMIZED TRIAL Source Type: research
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