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

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.

Study Overview

• Status: Terminated
• Conditions: Radiculopathy; Myelopathy; Cervical Degenerative Disc Disease
• Intervention / Treatment: Device: PRESTIGE LP™ Cervical Disc

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Beverly Hills, California, United States, 90210
      • Todd H. Lanman, M.D., INC.
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • Beaumont Hospital
  • Oregon
    • Portland, Oregon, United States, 97806
      • Kellogg M.D., Brain & Spine
  • South Carolina
    • West Columbia, South Carolina, United States, 29169
      • Lexington Brain and Spine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRESTIGE LP; Patients receive surgical treatment with the PRESTIGE LP™ Cervical Disc at two contiguous cervical levels from C3-C7.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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: 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".	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

Collaborators and Investigators

• Sponsor: Medtronic Spinal and Biologics

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2018
• Primary Completion (Actual): January 27, 2023
• Study Completion (Actual): January 27, 2023

Study Registration Dates

• First Submitted: February 20, 2017
• First Submitted That Met QC Criteria: February 20, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration; Radiculopathy; Spinal Cord Diseases
• Other Study ID Numbers: SD1701

Drug and device information, study documents

• 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