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Study of Safety & Effectiveness of PRESTIGE® LP Cervical Disc vs. Anterior Cervical Fusion in Cervical DDD

Primary Purpose

Cervical Degenerative Disc Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
PRESTIGE® LP Cervical Disc
ATLANTIS Anterior Cervical Plate
Sponsored by
Medtronic Spinal and Biologics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Degenerative Disc Disease focused on measuring Cervical Disc

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Has cervical degenerative disc disease as defined as: intractable radiculopathy and/or myelopathy with at least one of the following items producing symptomatic nerve root and/or spinal cord compression that is documented by patient history: a) herniated disc; b) osteophyte formation
  • One level requiring surgical treatment
  • C3-C4 disc to C6-C7 disc level involvement
  • Unresponsive to non-operative treatment for six weeks or presence of progressive symptoms or signs of cord compression
  • No previous surgical procedures at the involved level or any planned surgical procedure at the involved or adjacent level.
  • Preop Neck Disability index score ≥ 30
  • Preop Neck Pain score of ≥ 20 based on the Preop Neck & Arm Pain Questionnaire
  • Not pregnant at time of surgery
  • Willing and able to comply with study plan and able to understand and sign patient informed consent

Exclusion Criteria:

  • Any other cervical spinal condition requiring surgical treatment at the involved level

  • Documented or diagnosed cervical instability defined by radiographs showing

    1. Sagittal plane translation > 3.5mm or
    2. Sagittal plane angulation > 20 degrees.
  • More than one cervical level requiring surgery
  • A fused level adjacent to the level to be treated
  • Severe pathology of the facet joint of involved bodies
  • Previous surgery at the involved level
  • Previously diagnosed osteopenia or osteomalacia

  • Any of the following that may be associated with an osteoporosis diagnosis (if "Yes" to any of these, a DEXA Scan will be required to determine eligibility)

    1. Postmenopausal non-Black female over 60 years of age and weighs less than 140 pounds
    2. Postmenopausal female that has sustained a non-traumatic hip, spine, or wrist fracture
    3. Male over the age of 70
    4. Male over the age of 60 that has sustained a non-traumatic hip or spine fracture.

If the level of Bone Mineral Density is a T score of -3.5 or lower or a T score of -2.5 or lower with the vertebral crush fracture, then the patient is excluded.

  • Presence of spinal metastases
  • Overt or active bacterial infection, either local or systemic
  • Severe insulin dependent diabetes
  • Chronic or acute renal failure or history of renal disease
  • Temperature > 101º F oral at surgery
  • Documented allergy to stainless steel, titanium or a titanium alloy
  • Mentally incompetent
  • Is a prisoner
  • Is pregnant
  • Is an alcohol and/or drug abuser
  • Has received drugs which may interfere with bone metabolism within 2 weeks prior to the planned surgery date (steroids, methotrexate), excluding routine preop anti-inflammatories)
  • A history of endocrine or metabolic disorder known to affect osteogenesis
  • A condition that requires postop medications that interfere with the stability of the implant (steroids). This does not include low dose aspirin therapy.
  • Received treatment with an investigational therapy within 28 days prior to surgery or planned for 16 weeks following implantation.

Sites / Locations

  • Emory Orthopaedics and Spine Center
  • The Hughston Clinic, P.C.
  • Coeur d'Alene Spine and Brain, PLLC
  • Central Illinois Neuroscience
  • Indiana Spine
  • OrthoIndy
  • Cedar Neurological Surgeons, PC
  • Sports Medicine North
  • The Orthopaedic Center of St. Louis
  • Springfield Neurological Institute
  • Buffalo Neurosurgery Group
  • NeuroSpine Institute, LLC
  • Clinical Trials for South Carolina
  • Chattanooga Orthopaedic Group
  • Brain and Spine Center of Texas, L.L.P.
  • University of Virginia,Neurosurgery Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Investigational

Control

Arm Description

PRESTIGE® LP Cervical Disc

Control patients who received a ACDF fusion treatment from a previous IDE trial (NCT00642876)

Outcomes

Primary Outcome Measures

Rate of Overall Success
Rate of overall success is reported as the percentage of participants who met all of the following criteria: Postoperative Neck Disability Index score improvement of at least a 15-points from preoperative; Maintenance or improvement in neurological status; Disc height success which was defined as either the anterior or posterior measurements meeting the criteria of "Postoperative Height - 6 Week Postoperative Height ≥ -2mm"; No serious adverse event classified as implant associated or implant/surgical procedure associated; and No secondary surgical procedure classified as a "failure."

Secondary Outcome Measures

Success Rate of Neck Disability Index
Success rate of Neck Disability Index is reported as the percentage of participants whose neck disability index score met: Pre-treatment Score - Post-treatment Score ≥ 15.
Success Rate of Neurological Status
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 remain the same or improve from the time of the preoperative evaluation to the time period evaluated.
Rate of Disc Height Success
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
Neck Pain Success Rate
Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 100 max) was derived by multiplying 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: Preoperative Score - Postoperative Score > 0.
Arm Pain Success Rate
Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 100 max) was derived by multiplying 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: Preoperative Score - Postoperative Score > 0.
Success Rate of SF-36 PCS
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
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.
Gait Success Rate
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
Operative time was recorded from skin incision to wound closure.
Blood Loss
Hospital Stay
Rate of Secondary Surgery at Index Level
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 patients who had secondary surgeries at index level.
Change of Neck Disability Index Score From Baseline
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
Numerical rating scales were used to evaluate neck pain intensity and frequency. Patients 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, patients 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 to100) was the product 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
Numerical rating scales were also used to evaluate arm pain intensity and frequency. Patients 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, patients 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 100) was the product 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
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
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.

Full Information

First Posted
April 24, 2008
Last Updated
May 9, 2023
Sponsor
Medtronic Spinal and Biologics
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1. Study Identification

Unique Protocol Identification Number
NCT00667459
Brief Title
Study of Safety & Effectiveness of PRESTIGE® LP Cervical Disc vs. Anterior Cervical Fusion in Cervical DDD
Official Title
A Prospective, Multicenter, Controlled Clinical Trial of an Artificial Cervical Disc LP at a Single Level for Symptomatic Cervical Disc Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Spinal and Biologics

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this clinical trial is to evaluate the safety and effectiveness of the PRESTIGE® LP Cervical Disc as a method of treating patients with symptoms of cervical degenerative disc disease at a single level from C3-C4 to C6-C7.
Detailed Description
This pivotal clinical trial was conducted to compare treatment data of the investigational implant device,the PRESTIGE® LP Cervical Disc, with a control patient group receiving a plate. The PRESTIGE® LP Cervical Disc devices were implanted using an anterior surgical approach. Data from control patients receiving anterior cervical discectomy and fusion with an ATLANTIS Anterior Cervical Plate from the initial Artificial Cervical Disc study (NCT00642876) were compared as both treatment groups receive single-level surgical treatment from C3-C4 to C6-C7 for symptomatic cervical degenerative disc disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Degenerative Disc Disease
Keywords
Cervical Disc

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
280 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Investigational
Arm Type
Experimental
Arm Description
PRESTIGE® LP Cervical Disc
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Control patients who received a ACDF fusion treatment from a previous IDE trial (NCT00642876)
Intervention Type
Device
Intervention Name(s)
PRESTIGE® LP Cervical Disc
Other Intervention Name(s)
PRESTIGE® LP
Intervention Description
The PRESTIGE® LP Cervical Disc was inserted into the intervertebral disc space of the cervical spine using the anterior surgical approach.
Intervention Type
Device
Intervention Name(s)
ATLANTIS Anterior Cervical Plate
Other Intervention Name(s)
ATLANTIS plate
Intervention Description
Anterior cervical discectomy and fusion with ATLANTIS plate for control group
Primary Outcome Measure Information:
Title
Rate of Overall Success
Description
Rate of overall success is reported as the percentage of participants who met all of the following criteria: Postoperative Neck Disability Index score improvement of at least a 15-points from preoperative; Maintenance or improvement in neurological status; Disc height success which was defined as either the anterior or posterior measurements meeting the criteria of "Postoperative Height - 6 Week Postoperative Height ≥ -2mm"; No serious adverse event classified as implant associated or implant/surgical procedure associated; and No secondary surgical procedure classified as a "failure."
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Success Rate of Neck Disability Index
Description
Success rate of Neck Disability Index is reported as the percentage of participants whose neck disability index score met: Pre-treatment Score - Post-treatment Score ≥ 15.
Time Frame
24 months
Title
Success Rate of Neurological Status
Description
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 remain the same or improve from the time of the preoperative evaluation to the time period evaluated.
Time Frame
24 months
Title
Rate of Disc Height Success
Description
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
Time Frame
24 months
Title
Neck Pain Success Rate
Description
Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 100 max) was derived by multiplying 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: Preoperative Score - Postoperative Score > 0.
Time Frame
24 months
Title
Arm Pain Success Rate
Description
Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 100 max) was derived by multiplying 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: Preoperative Score - Postoperative Score > 0.
Time Frame
24 months
Title
Success Rate of SF-36 PCS
Description
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.
Time Frame
24 months
Title
Success Rate of SF-36 MCS
Description
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.
Time Frame
24 months
Title
Gait Success Rate
Description
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.
Time Frame
24 months
Title
Operative Time
Description
Operative time was recorded from skin incision to wound closure.
Time Frame
Time of operation, approximately 1.5 hrs.
Title
Blood Loss
Time Frame
During the time of operation, approximately 1.5 hours.
Title
Hospital Stay
Time Frame
During the time of hospital stay, average of 1 day.
Title
Rate of Secondary Surgery at Index Level
Description
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 patients who had secondary surgeries at index level.
Time Frame
24 months post-operation
Title
Change of Neck Disability Index Score From Baseline
Description
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.
Time Frame
Baseline and 24 months post-operation
Title
Change of Neck Pain Score From Baseline
Description
Numerical rating scales were used to evaluate neck pain intensity and frequency. Patients 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, patients 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 to100) was the product 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.
Time Frame
Baseline and 24 months post-operation
Title
Change of Arm Pain Score From Baseline
Description
Numerical rating scales were also used to evaluate arm pain intensity and frequency. Patients 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, patients 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 100) was the product 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.
Time Frame
Baseline and 24 months post-operation
Title
Change of General Health Status -- SF-36 PCS From Baseline
Description
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.
Time Frame
Baseline and 24 months post-operation
Title
Change of General Health Status -- SF-36 MCS From Baseline
Description
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.
Time Frame
Baseline and 24 months post-operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has cervical degenerative disc disease as defined as: intractable radiculopathy and/or myelopathy with at least one of the following items producing symptomatic nerve root and/or spinal cord compression that is documented by patient history: a) herniated disc; b) osteophyte formation One level requiring surgical treatment C3-C4 disc to C6-C7 disc level involvement Unresponsive to non-operative treatment for six weeks or presence of progressive symptoms or signs of cord compression No previous surgical procedures at the involved level or any planned surgical procedure at the involved or adjacent level. Preop Neck Disability index score ≥ 30 Preop Neck Pain score of ≥ 20 based on the Preop Neck & Arm Pain Questionnaire Not pregnant at time of surgery Willing and able to comply with study plan and able to understand and sign patient informed consent Exclusion Criteria: Any other cervical spinal condition requiring surgical treatment at the involved level Documented or diagnosed cervical instability defined by radiographs showing Sagittal plane translation > 3.5mm or Sagittal plane angulation > 20 degrees. More than one cervical level requiring surgery A fused level adjacent to the level to be treated Severe pathology of the facet joint of involved bodies Previous surgery at the involved level Previously diagnosed osteopenia or osteomalacia Any of the following that may be associated with an osteoporosis diagnosis (if "Yes" to any of these, a DEXA Scan will be required to determine eligibility) Postmenopausal non-Black female over 60 years of age and weighs less than 140 pounds Postmenopausal female that has sustained a non-traumatic hip, spine, or wrist fracture Male over the age of 70 Male over the age of 60 that has sustained a non-traumatic hip or spine fracture. If the level of Bone Mineral Density is a T score of -3.5 or lower or a T score of -2.5 or lower with the vertebral crush fracture, then the patient is excluded. Presence of spinal metastases Overt or active bacterial infection, either local or systemic Severe insulin dependent diabetes Chronic or acute renal failure or history of renal disease Temperature > 101º F oral at surgery Documented allergy to stainless steel, titanium or a titanium alloy Mentally incompetent Is a prisoner Is pregnant Is an alcohol and/or drug abuser Has received drugs which may interfere with bone metabolism within 2 weeks prior to the planned surgery date (steroids, methotrexate), excluding routine preop anti-inflammatories) A history of endocrine or metabolic disorder known to affect osteogenesis A condition that requires postop medications that interfere with the stability of the implant (steroids). This does not include low dose aspirin therapy. Received treatment with an investigational therapy within 28 days prior to surgery or planned for 16 weeks following implantation.
Facility Information:
Facility Name
Emory Orthopaedics and Spine Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
The Hughston Clinic, P.C.
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31908
Country
United States
Facility Name
Coeur d'Alene Spine and Brain, PLLC
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
Central Illinois Neuroscience
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61701
Country
United States
Facility Name
Indiana Spine
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
OrthoIndy
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Cedar Neurological Surgeons, PC
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403
Country
United States
Facility Name
Sports Medicine North
City
Peabody
State/Province
Massachusetts
ZIP/Postal Code
01960
Country
United States
Facility Name
The Orthopaedic Center of St. Louis
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Springfield Neurological Institute
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Buffalo Neurosurgery Group
City
West Seneca
State/Province
New York
ZIP/Postal Code
14224
Country
United States
Facility Name
NeuroSpine Institute, LLC
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Clinical Trials for South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Chattanooga Orthopaedic Group
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Brain and Spine Center of Texas, L.L.P.
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
University of Virginia,Neurosurgery Department
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31970051
Citation
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.
Results Reference
derived
PubMed Identifier
31075769
Citation
Gornet MF, Burkus JK, Shaffrey ME, Schranck FW, Copay AG. Cervical disc arthroplasty: 10-year outcomes of the Prestige LP cervical disc at a single level. J Neurosurg Spine. 2019 May 10;31(3):317-325. doi: 10.3171/2019.2.SPINE1956.
Results Reference
derived
PubMed Identifier
27441182
Citation
Gornet MF, Burkus JK, Shaffrey ME, Nian H, Harrell FE Jr. Cervical Disc Arthroplasty with Prestige LP Disc Versus Anterior Cervical Discectomy and Fusion: Seven-Year Outcomes. Int J Spine Surg. 2016 Jun 22;10:24. doi: 10.14444/3024. eCollection 2016.
Results Reference
derived

Learn more about this trial

Study of Safety & Effectiveness of PRESTIGE® LP Cervical Disc vs. Anterior Cervical Fusion in Cervical DDD

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