- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00667459
Study of Safety & Effectiveness of PRESTIGE® LP Cervical Disc vs. Anterior Cervical Fusion in Cervical DDD
A Prospective, Multicenter, Controlled Clinical Trial of an Artificial Cervical Disc LP at a Single Level for Symptomatic Cervical Disc Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30329
- Emory Orthopaedics and Spine Center
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Columbus, Georgia, United States, 31908
- The Hughston Clinic, P.C.
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Idaho
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Coeur d'Alene, Idaho, United States, 83814
- Coeur d'Alene Spine and Brain, PLLC
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Illinois
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Bloomington, Illinois, United States, 61701
- Central Illinois Neuroscience
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Indiana
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Carmel, Indiana, United States, 46032
- Indiana Spine
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Indianapolis, Indiana, United States, 46260
- OrthoIndy
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Iowa
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Cedar Rapids, Iowa, United States, 52403
- Cedar Neurological Surgeons, PC
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Massachusetts
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Peabody, Massachusetts, United States, 01960
- Sports Medicine North
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Missouri
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Chesterfield, Missouri, United States, 63017
- The Orthopaedic Center of St. Louis
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Springfield, Missouri, United States, 65804
- Springfield Neurological Institute
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New York
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West Seneca, New York, United States, 14224
- Buffalo Neurosurgery Group
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Oregon
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Eugene, Oregon, United States, 97401
- NeuroSpine Institute, LLC
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South Carolina
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Charleston, South Carolina, United States, 29406
- Clinical Trials for South Carolina
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Tennessee
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Chattanooga, Tennessee, United States, 37404
- Chattanooga Orthopaedic Group
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Texas
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Plano, Texas, United States, 75093
- Brain and Spine Center of Texas, L.L.P.
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Virginia
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Charlottesville, Virginia, United States, 22908
- University of Virginia,Neurosurgery Department
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Investigational
PRESTIGE® LP Cervical Disc
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The PRESTIGE® LP Cervical Disc was inserted into the intervertebral disc space of the cervical spine using the anterior surgical approach.
Other Names:
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Active Comparator: Control
Control patients who received a ACDF fusion treatment from a previous IDE trial (NCT00642876)
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Anterior cervical discectomy and fusion with ATLANTIS plate for control group
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Overall Success
Time Frame: 24 months
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Rate of overall success is reported as the percentage of participants who met all of the following criteria:
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24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Success Rate of Neck Disability Index
Time Frame: 24 months
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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.
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24 months
|
Success Rate of Neurological Status
Time Frame: 24 months
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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.
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24 months
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Rate of Disc Height Success
Time Frame: 24 months
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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
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24 months
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Neck Pain Success Rate
Time Frame: 24 months
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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.
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24 months
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Arm Pain Success Rate
Time Frame: 24 months
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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.
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24 months
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Success Rate of SF-36 PCS
Time Frame: 24 months
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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.
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24 months
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Success Rate of SF-36 MCS
Time Frame: 24 months
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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.
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24 months
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Gait Success Rate
Time Frame: 24 months
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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.
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24 months
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Operative Time
Time Frame: Time of operation, approximately 1.5 hrs.
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Operative time was recorded from skin incision to wound closure.
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Time of operation, approximately 1.5 hrs.
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Blood Loss
Time Frame: During the time of operation, approximately 1.5 hours.
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During the time of operation, approximately 1.5 hours.
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Hospital Stay
Time Frame: During the time of hospital stay, average of 1 day.
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During the time of hospital stay, average of 1 day.
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Rate of Secondary Surgery at Index Level
Time Frame: 24 months post-operation
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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.
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24 months post-operation
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Change of Neck Disability Index Score From Baseline
Time Frame: Baseline and 24 months post-operation
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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.
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Baseline and 24 months post-operation
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Change of Neck Pain Score From Baseline
Time Frame: Baseline and 24 months post-operation
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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.
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Baseline and 24 months post-operation
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Change of Arm Pain Score From Baseline
Time Frame: Baseline and 24 months post-operation
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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.
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Baseline and 24 months post-operation
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Change of General Health Status -- SF-36 PCS From Baseline
Time Frame: Baseline and 24 months post-operation
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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.
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Baseline and 24 months post-operation
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Change of General Health Status -- SF-36 MCS From Baseline
Time Frame: 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.
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Baseline and 24 months post-operation
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Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRESTIGE® LP Protocol, #P03-03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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