Cervical Degenerative Disc DiseaseNCT00637156
Study of the Safety and Effectiveness of the Artificial Cervical Disc - Low Profile Device at Two Adjacent Levels
A study testing PRESTIGE LP device at two adjacent levels and Bi-level fusion with ATLANTIS Cervical Plate System in people with Cervical Degenerative Disc Disease and Radiculopathy, run by Medtronic Spinal and Biologics at 29 sites in United States.
Trial summary
The purpose of this clinical investigation is to assess the safety and effectiveness of using the PRESTIGE-LP device in the treatment of patients with symptomatic degenerative disc disease at two adjacent levels of the cervical spine, with overall success being the primary endpoint of the clinical trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Degenerative Disc Disease, Radiculopathy, Myelopathy
- What is being tested?
- PRESTIGE LP device at two adjacent levels and Bi-level fusion with ATLANTIS Cervical Plate System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 397 participants
- Where
- 29 sitesUnited States
- Study dates
- Jun 2006to 1 Feb 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 28Show fewer
- 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
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
Crystal Clinic, Inc.; Akron General Medical Center
Akron, Ohio, 44333
OAA Orthopaedic Specialists
Allentown, Pennsylvania, 18104
Peachtree Neurosurgery, Northside Hospital
Atlanta, Georgia, 30342
Central Texas Spine Institute; Health South Surgical Center
Austin, Texas, 78731
The Center Orthopaedic & Neurosurgical Care & Research
Bend, Oregon, 97701
Todd Lanman, MD, FACS, A Professional Corp.;
Beverly Hills, California, 90210
University at Buffalo Neurosurgery, Inc. Kaleida Health-Buffalo General Medical center/Gates Vascular Institute
Buffalo, New York, 14203
Center for Sports Medicine and Orthopaedics; Memorial Hospital
Chattanooga, Tennessee, 37404
The Orthopedic Center of St. Louis; Barnes Jewish West County Hospital
Chesterfield, Missouri, 63017
Bone & Spine Surgery
Colton, California, 92324
The Hughston Clinic, P.C., Hughston Hospital and Rehabilitation Center
Columbus, Georgia, 31908
Neuro Spine & Pain Center; Lutheran Hospital
Fort Wayne, Indiana, 46804
Great Lakes Neurosurgical; Spectrum Health East Campus
Grand Rapids, Michigan, 49505
The Orthopaedic Center; Crestwood Medical Center
Huntsville, Alabama, 35801
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
East Tennessee Brain & Spine Center, Johnson City Medical Center
Johnson City, Tennessee, 37604
La Jolla Neurological Associates, AMC; Scripps Memorial Hospital La Jolla; Scripps Memorial Hospital Encinitas
La Jolla, California, 92037
Montana Neuro Science Institute; St. Patrick's Medical Center
Missoula, Montana, 59802
West Virginia University; Ruby Memorial Hospital, WVU Hospitals, Inc.
Morgantown, West Virginia, 26506
Delaware Neurosurgical Group; Christiana Care Health Systems
Newark, Delaware, 19713
Spinal Associates, Gulf Coast Hospital
Panama City, Florida, 32405
Allegheny Neurosurgery; Washington Hospital
Pittsburgh, Pennsylvania, 15212
Adams Neurosurgery; Mid Michigan Medical Center
Saginaw, Michigan, 48604
St. Mary's Spine Center; St. Mary's Hospital
San Francisco, California, 94117
Henry Ford Hospital
West Bloomfield, Michigan, 48322
Lexington Brain and Spine Institute
West Columbia, South Carolina, 29169
Buffalo Neurosurgery Group
West Seneca, New York, 14224
Central Ohio Neurological Surgeons; Mt. Carmel East Hospital
Westerville, Ohio, 43081
Virginia Brain and Spine; Winchester Medical Center
Winchester, Virginia, 22601
About this study
Official title: A Prospective, Randomized, Controlled, Multicenter Pivotal Clinical Trial of the Artificial Cervical Disc-LP at Two Levels for Symptomatic Cervical Disc Disease
The purpose of this clinical investigation is to assess the safety and effectiveness of using the PRESTIGE-LP device in the treatment of patients with symptomatic degenerative disc disease at two adjacent levels of the cervical spine, with overall success being the primary endpoint of the clinical trial. The primary objective is to show non-inferiority of the investigational device to the control treatment. If non-inferiority is established, superiority will also be examined as the secondary objective.
Read the detailed description
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.
- Being tested
- PRESTIGE LP device at two adjacent levels, Bi-level fusion with ATLANTIS Cervical Plate System
- Keywords
- Symptomatic DDD at Two Adjacent Levels of cervical spine
- Medical subject headings
- Radiculopathy, Spinal Cord Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRESTIGE LP device at two adjacent levelsDevice
Also called 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 SystemDevice
Also called plate, cervical plate, fusion, cervical fusion
Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
| Study group | Role | What they receive |
|---|---|---|
| PRESTIGE LP Device | Experimental | Not described Receives: Device: PRESTIGE LP device at two adjacent levels |
| ATLANTIS Cervical Plate System | Other | Not described Receives: Device: Bi-level fusion with ATLANTIS Cervical Plate System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (NDI) score improvement of at least a 15-point increase from preoperative;
- Maintenance or improvement in neurological status;
- No serious adverse event classified as implant associated or implant/surgical procedure associated; and
- No additional surgical procedure classified as a "failure."
Measured: 24 Months
Secondary outcomes (17)
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 the following criterion: Pre-treatment Score - Post-treatment Score ≥ 15.
Measured: 24 months
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 either remain the same or improve from the time of the preoperative evaluation to the time period evaluated.
Measured: 24 months
Neck Pain Success Rate
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.
Measured: 24 months
Arm Pain Success Rate
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.
Measured: 24 months
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.
Measured: 24 months
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.
Measured: 24 months
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
Measured: 24 months
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.
Measured: 24 months
Operative Time
Operative time was recorded from skin incision to wound closure.
Measured: Time of operation, an average of 1.7-2.1hrs
Blood Loss
Measured: During the time of operation, an average of 1.7-2.1 hrs
Hospital Stay
Measured: From admission to discharge, an average of 1.0-1.5 day
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 subjects who had secondary surgeries at index level.
Measured: 24 months
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.
Measured: Baseline and 24 months post-operation
Change of Neck Pain Score From Baseline
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.
Measured: Baseline and 24 months post-operation
Change of Arm Pain Score From Baseline
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.
Measured: Baseline and 24 months post-operation
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.
Measured: Baseline and 24 months post-operation
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.
Measured: Baseline and 24 months post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2008 (estimated)
- Study startJun 2006
- Primary completionJan 2011
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cervical Degenerative Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 397 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Spinal and Biologics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John K Burkus, M.D., Principal investigator, The Hughston Clinic, P.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00637156
- Sponsor's protocol ID
- PRESTIGE LP Two Level Study
- Status last verified
- Oct 2017
- First submitted
- 3 Mar 2008
- Last updated
- 1 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 31970051Gornet 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.
PubMed 31226684Lanman 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.
PubMed 28387616Gornet 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.
PubMed 28304237
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled, Multicenter Pivotal Clinical Trial of the Artificial Cervical Disc-LP at Two Levels for Symptomatic Cervical Disc Disease
- ClinicalTrials.gov ID
- NCT00637156
- Acronym / sponsor ID
- PRESTIGE LP Two Level Study
- Keywords
- Symptomatic DDD at Two Adjacent Levels of cervical spine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 397 participants (actual)
- Lead sponsor
- Medtronic Spinal and BiologicsIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Jan 2011 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 17 Mar 2008 (estimated)
- Results
- Posted 18 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical investigation is to assess the safety and effectiveness of using the PRESTIGE-LP device in the treatment of patients with symptomatic degenerative disc disease at two adjacent levels of the cervical spine, with overall success being the primary endpoint of the clinical trial. The primary objective is to show non-inferiority of the investigational device to the control treatment. If non-inferiority is established, superiority will also be examined as the secondary objective.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRESTIGE LP Device | Experimental | Device: PRESTIGE LP device at two adjacent levels |
| ATLANTIS Cervical Plate System | Other | Device: Bi-level fusion with ATLANTIS Cervical Plate System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRESTIGE LP device at two adjacent levelsAlso: disc, artificial disc, cervical discPRESTIGE 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. | Device | PRESTIGE LP Device |
| Bi-level fusion with ATLANTIS Cervical Plate SystemAlso: plate, cervical plate, fusion, cervical fusionBi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System. | Device | ATLANTIS Cervical Plate System |
Primary outcome
Rate of Overall Success
Time frame: 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."
17 secondary outcomes
Success Rate of Neck Disability Index
Time frame: 24 months
Success Rate of Neurological Status
Time frame: 24 months
Neck Pain Success Rate
Time frame: 24 months
Arm Pain Success Rate
Time frame: 24 months
Success Rate of SF-36 PCS
Time frame: 24 months
Success Rate of SF-36 MCS
Time frame: 24 months
Rate of Disc Height Success
Time frame: 24 months
Gait Success Rate
Time frame: 24 months
Operative Time
Time frame: Time of operation, an average of 1.7-2.1hrs
Blood Loss
Time frame: During the time of operation, an average of 1.7-2.1 hrs
Hospital Stay
Time frame: From admission to discharge, an average of 1.0-1.5 day
Rate of Secondary Surgery at Index Level
Time frame: 24 months
Change of Neck Disability Index Score From Baseline
Time frame: Baseline and 24 months post-operation
Change of Neck Pain Score From Baseline
Time frame: Baseline and 24 months post-operation
Change of Arm Pain Score From Baseline
Time frame: Baseline and 24 months post-operation
Change of General Health Status -- SF-36 PCS From Baseline
Time frame: Baseline and 24 months post-operation
Change of General Health Status -- SF-36 MCS From Baseline
Time frame: Baseline and 24 months post-operation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31970051Gornet 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.
- Derived from this study: PubMed 31226684Gornet 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.
- Derived from this study: PubMed 28387616Lanman 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.
- Derived from this study: PubMed 28304237Gornet 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John K Burkus, M.D. principal investigator
The Hughston Clinic, P.C.
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRESTIGE LP device at two adjacent levels and Bi-level fusion with ATLANTIS Cervical Plate System in people with Cervical Degenerative Disc Disease and Radiculopathy, run by Medtronic Spinal and Biologics at 29 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Overall Success (time frame: 24 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00637156, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2018.