Study of the Safety and Effectiveness of the Artificial Cervical Disc - Low Profile Device at Two Adjacent Levels

This clinical investigation is being conducted to evaluate the PRESTIGE-LP device's performance at two adjacent cervical levels (C3-C7) in the treatment of patients with symptomatic degenerative disc disease. One-half of the patients in this randomized pivotal clinical trial will be treated at two adjacent cervical levels with the PRESTIGE-LP device. The remaining patients will receive a bi-level anterior cervical discectomy and fusion with cortical ring allografts and the ATLANTIS Cervical Plate System.

• PRESTIGE LP device at two adjacent levels (Device), also known as disc, artificial disc, cervical disc: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
• Bi-level fusion with ATLANTIS Cervical Plate System (Device), also known as plate, cervical plate, fusion, cervical fusion: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.

Primary outcomes

• Rate of Overall Success [24 Months]: Rate of overall success is reported as the percentage of participants who met all of the following criteria: 1. Postoperative Neck Disability Index (NDI) score improvement of at least a 15-point increase from preoperative; 2. Maintenance or improvement in neurological status; 3. No serious adverse event classified as implant associated or implant/surgical procedure associated; and 4. No additional surgical procedure classified as a "failure."

Secondary outcomes

• Success Rate of Neck Disability Index [24 months]: Success rate of Neck Disability Index is reported as the percentage of participants whose neck disability index score met the following criterion: Pre-treatment Score - Post-treatment Score ≥ 15.
• Success Rate of Neurological Status [24 months]: Success rate of neurological status is reported as the percentage of participants who met neurological success defined as maintenance or improvement in all sections (motor, sensory, and reflexes) for the time period evaluated. In order for a section to be considered a success, each element in the section must either remain the same or improve from the time of the preoperative evaluation to the time period evaluated.
• Neck Pain Success Rate [24 months]: Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 20 max) was derived by adding the numerical rating scores from the pain intensity (0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be.") and frequency scales (0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time"). Neck pain success rate is reported as the percentage of participants whose neck pain improvement met the following criterion: Preoperative Score - Postoperative Score > 0.
• Arm Pain Success Rate [24 months]: Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 20 max) was derived by adding the numerical rating scores from the pain intensity (0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be.") and frequency scales (0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time"). Arm pain success rate is reported as the percentage of participants whose arm pain improvement met the following criterion: Preoperative Score - Postoperative Score > 0.
• Success Rate of SF-36 PCS [24 months]: Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success of SF-36 PCS was defined as: Post Score - Pre Score >= 0. The Success rate of SF-36 PCS is reported as the percentage of the participants who were classified as a success for SF-36 PCS.
• Success Rate of SF-36 MCS [24 months]: Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success of SF-36 MCS were defined as: Post Score - Pre Score >= 0. The Success rate of SF-36 MCS is reported as the percentage of the participants who were classified as a success for SF-36 MCS.
• Rate of Disc Height Success [24 months]: Disc height was assessed by determining the Functional Spinal Unit (FSU) height. The rate of disc height success is reported as the percentage of participants whose disc height for each level based on either the anterior or posterior measurements met the following criterion: Postoperative Height - 6 Week Postoperative Height >= -2mm
• Gait Success Rate [24 months]: Patient's gait was assessed by using Nurick's classification, and indicated either as normal or graded on a scale of 0 to 5. Success was defined as maintenance or improvement in the postoperative status as compared to the preoperative condition: Preoperative Score - Postoperative Score >= 0. The gait success rate is reported as the percentage of participants who had gait success.
• Operative Time [Time of operation, an average of 1.7-2.1hrs]: Operative time was recorded from skin incision to wound closure.
• Blood Loss [During the time of operation, an average of 1.7-2.1 hrs]
• Hospital Stay [From admission to discharge, an average of 1.0-1.5 day]
• Rate of Secondary Surgery at Index Level [24 months]: Secondary surgical procedures at the index level included revisions, removals, supplemental fixations and reoperations. Rate of secondary surgery at index level is reported as percentage of subjects who had secondary surgeries at index level.
• Change of Neck Disability Index Score From Baseline [Baseline and 24 months post-operation]: The self-administered Neck Disability Index (NDI) Questionnaire was used to assess patient neck pain and ability to function. The NDI scale ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability). Change of NDI was defined as NDI at 24 month minus NDI at baseline.
• Change of Neck Pain Score From Baseline [Baseline and 24 months post-operation]: Numerical rating scales were used to evaluate neck pain intensity and frequency. Subjects rated their neck pain intensity on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be." Similarly, subjects recorded their neck pain frequency on a scale from 0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time." The total neck pain score (0 to 20) was the addition of pain intensity and frequency scores. Change of neck pain score was defined as neck pain score at 24 months minus neck pain score at baseline.
• Change of Arm Pain Score From Baseline [Baseline and 24 months post-operation]: Numerical rating scales were also used to evaluate arm pain intensity and frequency. Subjects rated their arm pain intensity on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be." Similarly, subjects recorded their arm pain frequency on a scale from 0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time." The total arm pain score (0 to 20) was the addition of pain intensity and frequency scores. Change of arm pain score was defined as arm pain score at 24 months minus arm pain score at baseline.
• Change of General Health Status -- SF-36 PCS From Baseline [Baseline and 24 months post-operation]: The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS was between 0 and 100, with higher scores denoting better quality of life. Change of SF-36 PCS score was defined as PCS score at 24 months minus PCS score at baseline.
• Change of General Health Status -- SF-36 MCS From Baseline [Baseline and 24 months post-operation]: The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for MCS was between 0 and 100, with higher scores denoting better quality of life. Change of SF-36 MCS score was defined as MCS score at 24 months minus MCS score at baseline.

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Has cervical DDD at 2 adjacent cervical levels (C3-C7) requiring surgical treatment \& involving intractable radiculopathy, myelopathy, or both
* Has a herniated disc and/or osteophyte formation at each level to be treated that is producing symptomatic nerve root and/or spinal cord compression. The condition is documented by patient history, and the requirement for surgical treatment is evidenced by radiographic studies
* Unresponsive to non-operative treatment for approximately 6 weeks or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative management
* Has no previous surgical intervention at the involved levels or any subsequent planned/staged surgical procedure at the involved or adjacent level(s)
* Must be ≥ 18 years; skeletally mature at time of surgery
* Preoperative NDI score ≥ 30
* Preoperative neck pain score ≥ 8 based on the preoperative Neck and Arm Pain Questionnaire
* If a female of childbearing potential, patient is non-pregnant, non-nursing, and agrees not to become pregnant during the study period
* Is willing to comply with the study plan and sign Patient Informed Consent Form

Exclusion Criteria:

* Has a cervical spinal condition other than symptomatic cervical DDD requiring surgical treatment at the involved levels
* Has documented or diagnosed cervical instability relative to adjacent segments at either level, defined by dynamic (flexion/extension) radiographs showing: Sagittal plane translation > 3.5 mm, or Sagittal plane angulation > 20 degrees.
* Has more than two cervical levels requiring surgical treatment
* Has a fused level adjacent to the levels to be treated
* Has severe pathology of the facet joints of the involved vertebral bodies
* Has had previous surgical intervention at either one or both of the involved levels or at adjacent levels
* Has been previously diagnosed with osteopenia or osteomalacia
* Has any of the following that may be associated with a diagnosis of osteoporosis (If "Yes" to any of the below a DEXA Scan will be required to determine eligibility.)

  * Postmenopausal non-Black female over age of 60 who weighs < 140 pounds
  * Postmenopausal female who has sustained a non-traumatic hip, spine, or wrist fracture
  * Male > 70 years
  * Male > 60 years who has sustained a non-traumatic hip or spine fracture
  * If the level of BMD is a T score of -3.5 or lower or a T score of -2.5 or lower with vertebral crush fracture, then the patient is excluded from the study
* Has presence of spinal metastases
* Has overt or active bacterial infection, either local or systemic
* Has insulin dependent diabetes
* Is a tobacco user who does not agree to suspend smoking prior to surgery
* Has chronic or acute renal failure or prior history of renal disease
* Has a documented allergy or intolerance to stainless steel, titanium, or a titanium alloy
* Is mentally incompetent (If questionable, obtain psychiatric consult)
* Is a prisoner
* Is pregnant
* Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse
* Is involved with current or pending litigation regarding a spinal condition
* Has received drugs that may interfere with bone metabolism within two weeks prior to the planned date of spinal surgery (e.g., steroids or methotrexate), excluding routine perioperative anti-inflammatory drugs
* Has a history of an endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's Disease, renal osteodystrophy, Ehlers-Danlos Syndrome, or osteogenesis imperfecta)
* Has a condition that requires postoperative medications that interfere with the stability of the implant, such as steroids. (This does not include low-dose aspirin for prophylactic anticoagulation and routine perioperative anti-inflammatory drugs.)
* Has received treatment with an investigational therapy within 28 days prior to implantation surgery or such treatment is planned during the 16 weeks following implantation

Participant flow

Outcome results

• Rate of Overall Success (Primary), Number, percentage of participants: PRESTIGE LP Device 81.4; ATLANTIS Cervical Plate System 69.4 (p 1.000)
• Success Rate of Neck Disability Index (Secondary), Number, percentage of participants: PRESTIGE LP Device 87.9; ATLANTIS Cervical Plate System 79.2 (p 1.000)
• Success Rate of Neurological Status (Secondary), Number, percentage of participants: PRESTIGE LP Device 91.5; ATLANTIS Cervical Plate System 86.2 (p 1.000)
• Neck Pain Success Rate (Secondary), Number, percentage of participants: PRESTIGE LP Device 98.0; ATLANTIS Cervical Plate System 95.6 (p 1.000)
• Arm Pain Success Rate (Secondary), Number, percentage of participants: PRESTIGE LP Device 88.9; ATLANTIS Cervical Plate System 89.9 (p 0.997)
• Success Rate of SF-36 PCS (Secondary), Number, percentage of participants: PRESTIGE LP Device 90.4; ATLANTIS Cervical Plate System 87.8 (p 1.000)
• Success Rate of SF-36 MCS (Secondary), Number, percentage of participants: PRESTIGE LP Device 69.0; ATLANTIS Cervical Plate System 72.4 (p 0.945)
• Rate of Disc Height Success (Secondary), Number, percentage of participants: PRESTIGE LP Device 93.5; ATLANTIS Cervical Plate System 95.7 (p 0.997)
• Gait Success Rate (Secondary), Number, percentage of participants: PRESTIGE LP Device 100.0; ATLANTIS Cervical Plate System 98.7 (p 1.000)
• Operative Time (Secondary), Mean, hrs: PRESTIGE LP Device 2.1 +/- 0.8; ATLANTIS Cervical Plate System 1.7 +/- 0.7 (p 0.0)
• Blood Loss (Secondary), Mean, ml: PRESTIGE LP Device 67.2 +/- 64.1; ATLANTIS Cervical Plate System 55.7 +/- 46.3 (p 0.02)
• Hospital Stay (Secondary), Mean, days: PRESTIGE LP Device 1.2 +/- 0.5; ATLANTIS Cervical Plate System 1.3 +/- 1.0 (p 0.892)
• Rate of Secondary Surgery at Index Level (Secondary), Number, percentage of participants: PRESTIGE LP Device 2.4; ATLANTIS Cervical Plate System 8.0
• Change of Neck Disability Index Score From Baseline (Secondary), Mean, units on a scale: PRESTIGE LP Device 52.1 +/- 13.4; ATLANTIS Cervical Plate System 53.2 +/- 14.8
• Change of Neck Pain Score From Baseline (Secondary), Mean, units on a scale: PRESTIGE LP Device 16.2 +/- 2.9; ATLANTIS Cervical Plate System 16.3 +/- 2.6
• Change of Arm Pain Score From Baseline (Secondary), Mean, units on a scale: PRESTIGE LP Device 13.8 +/- 5.6; ATLANTIS Cervical Plate System 14.4 +/- 4.3
• Change of General Health Status -- SF-36 PCS From Baseline (Secondary), Mean, units on a scale: PRESTIGE LP Device 31.8 +/- 7.8; ATLANTIS Cervical Plate System 30.8 +/- 7.4
• Change of General Health Status -- SF-36 MCS From Baseline (Secondary), Mean, units on a scale: PRESTIGE LP Device 43.9 +/- 11.8; ATLANTIS Cervical Plate System 43.8 +/- 12.2

Adverse events

Time frame: up to 24 months

Serious adverse events by term

235 more terms not shown.

Other adverse events by term

463 more terms not shown.

• Results publication: Gornet MF, Lanman TH, Burkus JK, Hodges SD, McConnell JR, Dryer RF, Schranck FW, Copay AG. One-Level Versus 2-Level Treatment With Cervical Disc Arthroplasty or Fusion: Outcomes Up to 7 Years. Int J Spine Surg. 2019 Dec 31;13(6):551-560. doi: 10.14444/6076. eCollection 2019 Dec. PMID 31970051
• Results publication: Gornet MF, Lanman TH, Burkus JK, Dryer RF, McConnell JR, Hodges SD, Schranck FW. Two-level cervical disc arthroplasty versus anterior cervical discectomy and fusion: 10-year outcomes of a prospective, randomized investigational device exemption clinical trial. J Neurosurg Spine. 2019 Jun 21;31(4):508-518. doi: 10.3171/2019.4.SPINE19157. Print 2019 Oct 1. PMID 31226684
• Results publication: Lanman TH, Burkus JK, Dryer RG, Gornet MF, McConnell J, Hodges SD. 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. J Neurosurg Spine. 2017 Jul;27(1):7-19. doi: 10.3171/2016.11.SPINE16746. Epub 2017 Apr 7. PMID 28387616
• Results publication: Gornet MF, Lanman TH, Burkus JK, Hodges SD, McConnell JR, Dryer RF, Copay AG, Nian H, Harrell FE Jr. 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. J Neurosurg Spine. 2017 Jun;26(6):653-667. doi: 10.3171/2016.10.SPINE16264. Epub 2017 Mar 17. PMID 28304237

• John K Burkus, M.D., Principal investigator, The Hughston Clinic, P.C.