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An Investigation of the Metal Concentration in Patients Implanted With the PRESTIGE LP™ Cervical Disc at Two Contiguous Levels in the Cervical Spine

Primary Purpose

Cervical Degenerative Disc Disease, Radiculopathy, Myelopathy

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PRESTIGE LP™ Cervical Disc
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

Eligibility Criteria

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

Inclusion Criteria:

A patient must meet all of the following inclusion criteria to participate in this study:

  1. Has cervical degenerative disc disease at two (2) contiguous cervical levels (from C3 to C7) requiring surgical treatment and involving intractable radiculopathy, myelopathy or both;
  2. 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 (e.g., neck and/or arm pain, functional deficit and /or neurological deficit), and the requirement for surgical treatment is evidenced by radiographic studies (e.g., CT, MRI, x-rays, etc.);
  3. Has been unresponsive to non-operative treatment for at least six weeks or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative therapy;
  4. Has no previous surgical intervention at the involved levels or any other planned/staged surgical procedure at the involved levels;
  5. Has preoperative neck pain score ≥ 8 based on the preoperative Neck and Arm Pain Questionnaire;
  6. Must be at least 18 years of age and be skeletally mature at the time of surgery;
  7. If a female of childbearing potential, patient is non-pregnant, non-nursing, and agrees not to become pregnant during the study period;
  8. Is willing to comply with the study plan and sign the Patient Informed Consent Form.

Exclusion Criteria:

A patient will be excluded from participating in this study for any of the following reasons:

  1. Has a cervical spine condition other than symptomatic cervical degenerative disease requiring surgical treatment at the involved levels;
  2. Has documented or diagnosed cervical instability relative to contiguous segments at either level, defined by dynamic (flexion/extension) radiographs showing:

    1. Sagittal plane translation > 3.5 mm, or
    2. Sagittal plane angulation > 20°
  3. Has more than two cervical levels requiring surgical treatment;
  4. Has severe pathology of the facet joints of the involved vertebral bodies;
  5. Has had previous surgical intervention at either one or both of the involved levels;
  6. Has been previously diagnosed with osteopenia or osteomalacia;
  7. 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.):

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

    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

  8. Has presence of spinal metastases;
  9. Has overt or active bacterial infection, either local or systemic;
  10. Has chronic or acute renal failure or prior history of renal disease;
  11. Has a documented allergy or intolerance to titanium, or a titanium alloy;
  12. Is mentally incompetent. (If questionable, obtain psychiatric consult);
  13. Is a prisoner;
  14. Is pregnant;
  15. 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;
  16. 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);
  17. 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.);
  18. 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.
  19. 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).

Sites / Locations

  • Todd H. Lanman, M.D., INC.
  • Beaumont Hospital
  • Kellogg M.D., Brain & Spine
  • Lexington Brain and Spine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PRESTIGE LP

Arm Description

Patients receive surgical treatment with the PRESTIGE LP™ Cervical Disc at two contiguous cervical levels from C3-C7.

Outcomes

Primary Outcome Measures

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, standard deviation, median, minimum and maximum.

Secondary Outcome Measures

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: NDI score improvement of at least 15 points from baseline; Maintenance or improvement in neurological status; No serious AE classified as implant associated/related or implant/surgical procedure associated/related; No secondary surgical procedure classified as a "failure".
NDI success
The self-administered Neck Disability Index (NDI) Questionnaire (Vernon and Mior, 1996) 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
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. The pain score is derived by adding the numerical rating scores from the pain intensity and duration scales.
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.
Adverse Events (AE)
An AE is any untoward medical occurrence that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., abnormal laboratory finding), symptom, or disease temporally associated with the use of a product, whether or not considered related to the product(s) under study. This definition includes events related to the procedures involved and/or worsening of pre-existing conditions.
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.

Full Information

First Posted
February 20, 2017
Last Updated
August 22, 2023
Sponsor
Medtronic Spinal and Biologics
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1. Study Identification

Unique Protocol Identification Number
NCT03062657
Brief Title
An Investigation of the Metal Concentration in Patients Implanted With the PRESTIGE LP™ Cervical Disc at Two Contiguous Levels in the Cervical Spine
Official Title
An Investigation of the Metal Concentration in Patients Implanted With the PRESTIGE LP™ Cervical Disc at Two Contiguous Levels in the Cervical Spine
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
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.
Study Start Date
June 6, 2018 (Actual)
Primary Completion Date
January 27, 2023 (Actual)
Study Completion Date
January 27, 2023 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PRESTIGE LP
Arm Type
Experimental
Arm Description
Patients receive surgical treatment with the PRESTIGE LP™ Cervical Disc at two contiguous cervical levels from C3-C7.
Intervention Type
Device
Intervention Name(s)
PRESTIGE LP™ Cervical Disc
Intervention Description
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.
Primary Outcome Measure Information:
Title
Concentrations of Titanium, Vanadium, and Aluminum in the blood serum
Description
The concentrations of Titanium, Vanadium, and Aluminum at different time points will be summarized using mean, standard deviation, median, minimum and maximum.
Time Frame
preoperative, 6 weeks, and 12 months
Secondary Outcome Measure Information:
Title
Overall success
Description
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: NDI score improvement of at least 15 points from baseline; Maintenance or improvement in neurological status; No serious AE classified as implant associated/related or implant/surgical procedure associated/related; No secondary surgical procedure classified as a "failure".
Time Frame
3, 6, and 12 months
Title
NDI success
Description
The self-administered Neck Disability Index (NDI) Questionnaire (Vernon and Mior, 1996) 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
Time Frame
3, 6, and 12 months
Title
Neck pain and Arm pain
Description
Numerical rating scales adapted in part from Measuring Health (McDowell and Newell, 1996) will be used to evaluate neck pain and arm pain. The pain score is derived by adding the numerical rating scores from the pain intensity and duration scales.
Time Frame
3, 6, and 12 months
Title
Neurological success
Description
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.
Time Frame
3, 6, and 12 months
Title
Adverse Events (AE)
Description
An AE is any untoward medical occurrence that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., abnormal laboratory finding), symptom, or disease temporally associated with the use of a product, whether or not considered related to the product(s) under study. This definition includes events related to the procedures involved and/or worsening of pre-existing conditions.
Time Frame
3, 6, and 12 months
Title
Secondary surgery at index level
Description
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.
Time Frame
3, 6, and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A patient must meet all of the following inclusion criteria to participate in this study: Has cervical degenerative disc disease at two (2) contiguous cervical levels (from C3 to C7) requiring surgical treatment and 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 (e.g., neck and/or arm pain, functional deficit and /or neurological deficit), and the requirement for surgical treatment is evidenced by radiographic studies (e.g., CT, MRI, x-rays, etc.); Has been unresponsive to non-operative treatment for at least six weeks or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative therapy; Has no previous surgical intervention at the involved levels or any other planned/staged surgical procedure at the involved levels; Has preoperative neck pain score ≥ 8 based on the preoperative Neck and Arm Pain Questionnaire; Must be at least 18 years of age and be skeletally mature at the time of surgery; 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 the Patient Informed Consent Form. 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: Sagittal plane translation > 3.5 mm, or Sagittal plane angulation > 20° 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.): . Postmenopausal non-Black female over 60 years of age who weighs less than 140 pounds. Postmenopausal female who has sustained a non-traumatic hip, spine or wrist fracture. Male over the age of 70. Male over the age of 60 who has sustained a non-traumatic hip or spine fracture. 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).
Facility Information:
Facility Name
Todd H. Lanman, M.D., INC.
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Kellogg M.D., Brain & Spine
City
Portland
State/Province
Oregon
ZIP/Postal Code
97806
Country
United States
Facility Name
Lexington Brain and Spine
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States

12. IPD Sharing Statement

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An Investigation of the Metal Concentration in Patients Implanted With the PRESTIGE LP™ Cervical Disc at Two Contiguous Levels in the Cervical Spine

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