Studies

July 21,2022

3Spine, Inc. Announces IDE Approval

3Spine, Inc., a medical device company developing total joint replacement for the lumbar spine, today announced FDA Investigational Device Exemption (IDE) approval for their US pivotal clinical trial. The company previously completed contracting and site initiation at 16 US centers for a prospective real-world evidence (RWE) fusion study, which has been enrolling since May 2021. As sites complete enrollment of their RWE cohort, each center becomes eligible to participate in the…

March 30,2022

A Prospective Study of Lumbar Facet Arthroplasty in the Treatment of Degenerative Spondylolisthesis and Stenosis: Early Cost-effective Assessment from the Total Posterior Spine System (TOPS™) IDE Study

Background Given the increased attention to functional improvement in spine surgery as it relates to motion preservation, activities of daily living, and cost, it is critical to fully understand the healthcare economic impact of new devices being tested in large FDA randomized controlled trials (RCT). The purpose of this analysis was to comprehensively evaluate the cost-effectiveness of the novel Total Posterior Spine (TOPS™) System investigational device compared with the trial…

October 15,2021

Single and Multilevel Lumbar Total Disc Replacement Adjacent to L5-S1 ALIF (Lumbar Hybrid): 6 Years of Follow-up

Background Single and multilevel lumbar arthroplasty has had excellent results, but the L5-S1 level frequently has pathology that precludes arthroplasty. This study evaluated clinical outcomes and sagittal range of motion (ROM) of operated levels and adjacent motion segments in single- and multiple-level ProDisc-L above a simultaneous L5-S1 fusion (hybrid) after a 2- to 6-year follow-up.   Methods In this prospective cohort study, 46 patients underwent simultaneous lumbar total disc replacement…

October 02,2021

Outpatient Versus Inpatient Anterior Lumbar Spine Surgery: A Multisite, Comparative Analysis of Patient Safety Measures

Background The frequency and complexity of spinal surgery performed in an ambulatory surgery center (ASC) is increasing. However, safety and efficacy data of most spinal procedures adapted to the ASC are sparse and have focused on anterior cervical surgery. The purpose of this study was to compare the 90-day complication and readmission rates of anterior lumbar spine surgery performed in an ASC or inpatient setting.   Methods We performed a…

November 01,2020

The Effect of ACDF or Arthroplasty on Cervicogenic Headaches: A Post Hoc Analysis of a Prospective, Multicenter Study With 10-Year Follow-up

Study Design This was a post hoc analysis of a prospective FDA-IDE study. Objective: The purpose of this study is to determine the effectiveness of a 2-level anterior cervical discectomy and fusion (ACDF) or cervical disk arthroplasty (CDA) at relieving headaches associated with cervical radiculopathy or myelopathy at 10 years postoperative. Background: To our knowledge, there is no large, prospective study that has examined the efficacy of cervical spine surgery…

October 14,2020

Low Complication Rate of Anterior Lumbar Spine Surgery in an Ambulatory Surgery Center

Background As healthcare costs rise, attempts are being made to perform an increasing proportion of spine surgery in ambulatory surgery centers (ASCs). ASCs are more efficient, both economically and functionally. There remains uncertainty regarding the safety of performing anterior lumbar procedures requiring vascular access, as little has been published on this subset of patients.   Methods This is a consecutive case series analysis of anterior lumbar spine surgeries that were…

October 02,2020

Prospective, multicenter clinical trial comparing M6-C compressible six degrees of freedom cervical disc with anterior cervical discectomy and fusion for the treatment of single-level degenerative cervical radiculopathy: 2-year results of an FDA investigational device exemption study

BACKGROUND Various designs of total disc replacement (TDR) devices have been compared to anterior cervical discectomy and fusion (ACDF) with favorable outcomes in FDA-approved investigational device exemption trials. The design of M6-C with a compressible viscoelastic nuclear core and an annular structure is substantially different than prior designs and has previously demonstrated favorable kinematics and clinical outcomes in small case series.   PURPOSE To evaluate the safety and effectiveness of…

September 01,2020

Reduction in opioid medication use after arthroplasty with Prestige LP cervical disc as compared to ACDF in patients with two-level surgery: a randomized study with 10-year follow-up

BACKGROUND CONTEXT Evaluation of 10-year clinical safety and effectiveness of cervical disc arthroplasty (CDA) using the Prestige LP™ disc to treat degenerative cervical spine disease at two adjacent levels has been completed and published. One of the contributing factors to the current opioid crisis in the U. is increased opioid prescription for back and neck pain. Better surgical outcomes may lead to less use of pain medications for CDA patients.…

August 14,2020

Restoration of Spinal Motion: Conversion of Anterior Cervical Fusion With Pseudarthrosis to Artificial Disc Replacement

Background Describe the technique and outcomes of the conversion of prior anterior cervical discectomy and fusion (ACDF) with pseudarthrosis to an artificial disc replacement (ADR).   Methods Case report. Five patients completed the following pain and function questionnaires at baseline and postoperatively: visual analog pain scale (VAS), Neck Disability Index (NDI), PROMIS Emotional Distress-Depression Short Form-4a (P-EDD), PROMIS Pain Interference Short Form 6b (P-PI), and PROMIS Physical Function Short Form-10a…

July 31,2020

Mechanical failure of the Mobi-C implant for artificial cervical disc replacement: report of 4 cases

Abstract Cervical spondylosis is one of the most commonly treated conditions in neurosurgery. Increasingly, cervical disc replacement (CDR) has become an alternative to traditional arthrodesis, particularly when treating younger patients. Thus, surgeons continue to gain a greater understanding of short- and long-term complications of arthroplasty. Here, the authors present a series of 4 patients initially treated with Mobi-C artificial disc implants who developed postoperative neck pain. Dynamic imaging revealed segmental…

April 15,2020

The Safety of Single and Multilevel Cervical Total Disc Replacement in Ambulatory Surgery Centers

Objective Evaluate the safety profile of single- and multilevel cervical artificial disc replacement (ADR) performed in an outpatient setting.   Background As healthcare costs rise, attempts are made to perform an increasing proportion of spine surgery in ambulatory surgery centers (ASCs). ASCs are more efficient, economically and functionally. Few studies have published on the safety profile of multilevel cervical ADR.   Methods We have performed an analysis of all consecutive…

March 13,2020

Occurrence and clinical implications of heterotopic ossification after cervical disc arthroplasty with the Prestige LP Cervical Disc at 2 contiguous levels

OBJECTIVE The authors sought to assess the impact of heterotopic ossification (HO) on clinical outcomes and angular range of motion (ROM) after cervical disc arthroplasty (CDA) performed with the Prestige LP Cervical Disc (Prestige LP disc) at 2 levels.   METHODS HO was assessed and graded from 0 to IV for increasing severity on lateral neutral radiographs at each visit in 209 patients who underwent implantation of Prestige LP discs…

December 13,2019

One-Level Versus 2-Level Treatment With Cervical Disc Arthroplasty or Fusion: Outcomes Up to 7 Years

Background Anterior cervical discectomy and fusion (ACDF) and cervical disc arthroplasty (CDA) have been used to treat degenerative disc disease at single as well as multiple cervical levels. This study compares the safety and efficacy of 1-level versus 2-level CDA and ACDF.   Methods In total, 545 and 397 patients with degenerative disc disease were studied in 1-level and 2-level Food and Drug Administration (FDA)–approved clinical trials, respectively: CDA (n = 280…

June 21,2019

Two-level cervical disc arthroplasty versus anterior cervical discectomy and fusion: 10-year outcomes of a prospective, randomized investigational device exemption clinical trial

OBJECTIVE The authors assessed the 10-year clinical safety and effectiveness of cervical disc arthroplasty (CDA) to treat degenerative cervical spine disease at 2 adjacent levels compared to anterior cervical discectomy and fusion (ACDF).   METHODS A prospective, randomized, controlled, multicenter FDA-approved clinical trial was conducted comparing the low-profile titanium ceramic composite–based Prestige LP Cervical Disc (n = 209) at two levels with ACDF (n = 188). Ten-year follow-up data from…

February 15,2019

Postoperative direct health care costs of lumbar discectomy are reduced with the use of a novel annular closure device in high-risk patients

BACKGROUND Lumbar discectomy is largely successful surgical procedure; however, reherniation rates in patients with large annular defects are as high as 27%. The expense associated with a revision surgery places significant burden on the healthcare system.   METHODS All-cause index level reoperations were reviewed from a multicenter, randomized controlled superiority trial that allocated 554 high-risk discectomy patients with large annular defects to either control or ACD. Medicare and private insurer…

December 01,2018

Treatment of Cervical Myelopathy: Long-term Outcomes of Arthroplasty for Myelopathy Versus Radiculopathy, And Arthroplasty Versus Arthrodesis for Myelopathy

Objective To compare the long-term safety and effectiveness of CDA for myelopathy versus radiculopathy.   Background CDA for myelopathy is safe and effective in short term.   Results All groups improved significantly for NDI, neck/arm pain, and physical component summary (PCS) scores from preoperative to postoperative. CDA Myelopathy versus CDA Radiculopathy: 2- and 7-year improvements were not significantly different. The 7-year score improvements for CDA Myelopathy and CDA Radiculopathy were:…

April 10,2017

Long-term clinical and radiographic outcomes of the Prestige LP artificial cervical disc replacement at 2 levels: results from a prospective randomized controlled clinical trial

OBJECTIVE The aim of this study was to assess long-term clinical safety and effectiveness in patients undergoing anterior cervical surgery using the Prestige LP artificial disc replacement (ADR) prosthesis to treat degenerative cervical spine disease at 2 adjacent levels compared with anterior cervical discectomy and fusion (ACDF).  ...

March 31,2017

Cervical disc arthroplasty with the Prestige LP disc versus anterior cervical discectomy and fusion, at 2 levels: results of a prospective, multicenter randomized controlled clinical trial at 24 months

OBJECTIVE The authors compared the efficacy and safety of arthroplasty using the Prestige LP cervical disc with those of anterior cervical discectomy and fusion (ACDF) for the treatment of degenerative disc disease (DDD) at 2 adjacent levels.   METHODS Patients from 30 investigational sites were randomized to 1 of 2 groups: investigational patients (209) underwent arthroplasty using a Prestige LP artificial disc, and control patients (188) underwent ACDF with a…

March 20,2017

“Text neck”: an epidemic of the modern era of cell phones?

Never before has a technology been so universally accepted as the modern era cell phone, otherwise known as the smart phone. They are everywhere. Anywhere one looks, a person staring at their smart phone will be encountered. Walk down a busy city street and try to find someone that makes eye contact; you are more likely to literally run into somebody walking toward you so engrossed in their smart phone…

July 12,2016

Access strategies for revision or explantation of the Charité lumbar artificial disc replacement

Todd H. Lanman, MD, FAANS, FACS (et al)   Many lumbar disc prostheses are constantly in development. The goal in each is to preserve mobility in patients with degenerative disc disease. In this study, Dr. Lanman and his colleagues examine the advantages and disadvantage of lumbar artificial disc replacement (ADR) compared with anterior interbody fusion (ALIF). Mainly, the physicians are concerned with the potential for displacement of the implants or…

July 12,2016

The Latest Lessons Learned from Retrieval Analyses of Ultra-High Molecular Weight Polyethylene, Metal-on-Metal, and Alternative Bearing Total Disc Replacements

Todd H. Lanman, MD, FAANS, FACS (et al)   The field of cervical and lumbar total disc replacements is expanding as physicians gain better understanding of how the body responds to various treatments. Dr. Lanman was one of several physicians who shared their expert knowledge regarding the human body's reaction to various devices and surgical techniques. This study addressed physician observation about the advancements that have been made in understanding…

July 12,2016

Retrieval analysis of PEEK rods for posterior fusion and motion preservation

Todd H. Lanman, MD, FAANS, FACS (et al)   A new synthetic rod system was introduced in 2006 as an alternative for metallic rods often used for posterior spinal fusion. The new rod design is intended to improve motion preservation for patients that need spinal fusion surgery. The new rods are made from a compound called polyaryl-ether-ether-ketone or "PEEK." Dr. Lanman participated in this study to analyze how PEEK rod…

July 12,2016

UHMWPE Wear Debris and Tissue Reactions Are Reduced for Contemporary Designs of Lumbar Total Disc Replacements

Todd H. Lanman, MD, FAANS, FACS (et al)   Lumbar total disc replacement is a surgical procedure that is used to relieve back pain and maintain maximum physical mobility in patients. Medical technology is rapidly developing to give patients new options for surgical implants. The newest devices bond metal and synthetic materials (polyethylene) with surgical techniques that form a durable bond with bone. This study was intended to evaluate the…