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Study terminated prematurely as agreed by the FDA. The FDA were satisfied that no further data was required, despite the total number of patients who completed the study in full not being the agreed upon number.
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This clinical study will assess the metal concentrations present in the blood serum of patients who receive surgical treatment with the PRESTIGE LP™ Cervical Disc at two contiguous cervical levels from C3-C7. The information obtained from this clinical investigation will be used to support the post market surveillance for a PMA supplement for the PRESTIGE LP™ Cervical Disc implanted at two contiguous levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRESTIGE LP | Experimental | Patients receive surgical treatment with the PRESTIGE LP™ Cervical Disc at two contiguous cervical levels from C3-C7. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRESTIGE LP™ Cervical Disc | Device | The PRESTIGE LP™ Cervical Disc is an artificial cervical disc comprising of two low-profile metal plates that interface through a ball and trough mechanism, permitting segmental spinal motion. The PRESTIGE LP™ Cervical Disc was approved by the Food and Drug Administration (FDA) to be used at a single and two contiguous levels. |
| Measure | Description | Time Frame |
|---|---|---|
| Concentrations of Titanium, Vanadium, and Aluminum in the Blood Serum | The concentrations of Titanium, Vanadium, and Aluminum at different time points will be summarized using mean and standard deviation. One participant did not receive metal concentration analysis at baseline, therefore the baseline number of participants for these measures N = 24. | Preoperative, 6 weeks, and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Achieved Overall Success | The patients enrolled in the study who receive the PRESTIGE LP™ Cervical Disc at two contiguous levels will be considered an overall success if the following criteria are met:
|
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Inclusion Criteria:
A patient must meet all of the following inclusion criteria to participate in this study:
Exclusion Criteria:
A patient will be excluded from participating in this study for any of the following reasons:
Has a cervical spine condition other than symptomatic cervical degenerative disease requiring surgical treatment at the involved levels;
Has documented or diagnosed cervical instability relative to contiguous segments at either level, defined by dynamic (flexion/extension) radiographs showing:
Has more than two cervical levels requiring surgical treatment;
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;
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 risk factors, a DEXA Scan will be required to determine eligibility.):
If the level of BMD is a T score of -3.5 or lower (i.e., -3.6, -3.7, etc.) or a T score of -2.5 or lower (i.e., -2.6, -2.7 etc.) 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 chronic or acute renal failure or prior history of renal disease;
Has a documented allergy or intolerance to titanium, or a titanium alloy;
Is mentally incompetent. (If questionable, obtain psychiatric consult);
Is a prisoner;
Is pregnant;
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 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.
Is currently taking or has had chronic usage of certain prescription medications (e.g., Cloxacillin, an antibiotic used for prophylaxis against surgical infections, and/or Clotrimazole).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Todd H. Lanman, M.D., INC. | Beverly Hills | California | 90210 | United States | ||
| Beaumont Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | PRESTIGE LP | Patients receive surgical treatment with the PRESTIGE LP™ Cervical Disc at two contiguous cervical levels from C3-C7. PRESTIGE LP™ Cervical Disc: The PRESTIGE LP™ Cervical Disc is an artificial cervical disc comprising of two low-profile metal plates that interface through a ball and trough mechanism, permitting segmental spinal motion. The PRESTIGE LP™ Cervical Disc was approved by the Food and Drug Administration (FDA) to be used at a single and two contiguous levels. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 15, 2019 | Jan 26, 2024 |
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| 3, 6, and 12 months |
| Number of Participants Who Achieved NDI Success | The self-administered Neck Disability Index (NDI) Questionnaire will be used. Success for each individual patient will be defined as pain/disability improvement postoperatively according to the following definition: Preoperative Score - Postoperative Score > 15 | 3, 6, and 12 months |
| Neck Pain and Arm Pain | Numerical rating scales adapted in part from Measuring Health (McDowell and Newell, 1996) will be used to evaluate neck pain and arm pain. Intensity of pain is ranked from 0-10 with 0 being no pain and 10 being pain as bad as it could be; duration of pain is ranked from 0-10 with 0 being none of the time and 10 being pain all of the time. The pain score is derived by adding the numerical rating scores from the pain intensity and duration scales. Therefore the total pain is ranked between 0-20 with 0 being no pain, none of the time; and 20 being maximum pain, constantly. | Preoperative, 3, 6, and 12 months |
| Number of Participants Who Achieved Neurological Success | Neurological status is based on motor function, sensory function, and reflexes. Each of the categories is comprised of a number of elements. Postoperative evaluations of each element will be compared to the preoperative evaluations. Success will be defined as maintenance or improvement in each element for the time period evaluated. | 3, 6, and 12 months |
| Number of Participants Who Underwent Secondary Surgery at Index Level | Some AEs or treatment failures may lead to a secondary surgical intervention at an operated index level. All patients undergoing a secondary surgical intervention at any operated index level will be followed. | 3, 6, and 12 months |
| Royal Oak |
| Michigan |
| 48073 |
| United States |
| Kellogg M.D., Brain & Spine | Portland | Oregon | 97806 | United States |
| Lexington Brain and Spine | West Columbia | South Carolina | 29169 | United States |
| 6 Week Follow-Up |
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| 3 Month Follow-Up |
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| 6 Month Follow-Up |
|
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | PRESTIGE LP | Patients receive surgical treatment with the PRESTIGE LP™ Cervical Disc at two contiguous cervical levels from C3-C7. PRESTIGE LP™ Cervical Disc: The PRESTIGE LP™ Cervical Disc is an artificial cervical disc comprising of two low-profile metal plates that interface through a ball and trough mechanism, permitting segmental spinal motion. The PRESTIGE LP™ Cervical Disc was approved by the Food and Drug Administration (FDA) to be used at a single and two contiguous levels. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Concentrations of Titanium, Vanadium, and Aluminum in the Blood Serum | The concentrations of Titanium, Vanadium, and Aluminum at different time points will be summarized using mean and standard deviation. One participant did not receive metal concentration analysis at baseline, therefore the baseline number of participants for these measures N = 24. | Due to patient drop out not all patients attended every visit | Posted | Mean | Standard Deviation | ng/ml | Preoperative, 6 weeks, and 12 months |
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| |||||||||||||||||||||||||||
| Secondary | Number of Participants Who Achieved Overall Success | The patients enrolled in the study who receive the PRESTIGE LP™ Cervical Disc at two contiguous levels will be considered an overall success if the following criteria are met:
| 17 patients data are presented at 3 months 16 patients data are presented at 6 months 18 patients data are presented at 12 months | Posted | Count of Participants | Participants | 3, 6, and 12 months |
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| |||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Achieved NDI Success | The self-administered Neck Disability Index (NDI) Questionnaire will be used. Success for each individual patient will be defined as pain/disability improvement postoperatively according to the following definition: Preoperative Score - Postoperative Score > 15 | Due to drop out, not all patients were present for each visit. | Posted | Count of Participants | Participants | 3, 6, and 12 months |
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| Secondary | Neck Pain and Arm Pain | Numerical rating scales adapted in part from Measuring Health (McDowell and Newell, 1996) will be used to evaluate neck pain and arm pain. Intensity of pain is ranked from 0-10 with 0 being no pain and 10 being pain as bad as it could be; duration of pain is ranked from 0-10 with 0 being none of the time and 10 being pain all of the time. The pain score is derived by adding the numerical rating scores from the pain intensity and duration scales. Therefore the total pain is ranked between 0-20 with 0 being no pain, none of the time; and 20 being maximum pain, constantly. | Due to drop out, not all patients were present for each visit. | Posted | Mean | Standard Deviation | Score on a scale | Preoperative, 3, 6, and 12 months |
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| Secondary | Number of Participants Who Achieved Neurological Success | Neurological status is based on motor function, sensory function, and reflexes. Each of the categories is comprised of a number of elements. Postoperative evaluations of each element will be compared to the preoperative evaluations. Success will be defined as maintenance or improvement in each element for the time period evaluated. | Due to drop out, not all patients were present for each visit. | Posted | Count of Participants | Participants | 3, 6, and 12 months |
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| Secondary | Number of Participants Who Underwent Secondary Surgery at Index Level | Some AEs or treatment failures may lead to a secondary surgical intervention at an operated index level. All patients undergoing a secondary surgical intervention at any operated index level will be followed. | Due to participant drop-out/missed visits, the number of participants per timepoint varies. | Posted | Count of Participants | Participants | 3, 6, and 12 months |
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Adverse event data were collected from baseline to participant completion; specifically the pre-operative, 6 weeks, 3-months, 6-months and 12-months follow-up visits.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PRESTIGE LP | Patients receive surgical treatment with the PRESTIGE LP™ Cervical Disc at two contiguous cervical levels from C3-C7. PRESTIGE LP™ Cervical Disc: The PRESTIGE LP™ Cervical Disc is an artificial cervical disc comprising of two low-profile metal plates that interface through a ball and trough mechanism, permitting segmental spinal motion. The PRESTIGE LP™ Cervical Disc was approved by the Food and Drug Administration (FDA) to be used at a single and two contiguous levels. | 0 | 25 | 4 | 25 | 14 | 25 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arm Pain (Non-Cervical) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Spinal Cord Disturbance | Nervous system disorders | Systematic Assessment |
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| Other Pain | General disorders | Systematic Assessment |
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| Spinal Event (Cervical Non-Study Surgery) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysphagia/Dysphonia (Grade 1/2) | Gastrointestinal disorders | Systematic Assessment |
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| Neck and/or Arm Pain (Grade 1/2) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Neurological (Grade 1/2) | Nervous system disorders | Systematic Assessment |
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| Other Pain (Grade 1/2) | General disorders | Systematic Assessment |
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| Trauma (Grade 1/2) | Injury, poisoning and procedural complications | Systematic Assessment |
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In agreement with the FDA, the study was terminated early, this lead to a sample size smaller than initially planned (30 planned, 25 enrolled). A short sample period was also used, however this was in agreement with the FDA based on previous evidence that the sample period would be sufficient.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rhys Jones, PhD; Senior Clinical Research Specialist | Medtronic | +44 7826874430 | rhys.j.jones@medtronic.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 16, 2020 | Jan 26, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011843 | Radiculopathy |
| D013118 | Spinal Cord Diseases |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D002493 | Central Nervous System Diseases |
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| Unknown or Not Reported |
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| Titanium at 12 months |
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| Vanadium at Preoperative |
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| Vanadium at 6 weeks |
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| Vanadium at 12 months |
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| Aluminum at Preoperative |
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| Aluminum at 6 weeks |
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| Aluminum at 12 months |
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