Clinical trial NCT03062657: 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
Overall status: TERMINATED
Phase: NA
Conditions: Cervical Degenerative Disc Disease
Radiculopathy
Myelopathy
Lead sponsor: Medtronic Spinal and Biologics
Sponsor class: INDUSTRY
First posted: 2017-02-23
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Concentrations of Titanium, Vanadium, and Aluminum in the Blood Serum
timeFrame: Preoperative, 6 weeks, and 12 months
Secondary outcomes:
measure: Number of Participants Who Achieved Overall Success
timeFrame: 3, 6, and 12 months
measure: Number of Participants Who Achieved NDI Success
timeFrame: 3, 6, and 12 months
measure: Neck Pain and Arm Pain
timeFrame: Preoperative, 3, 6, and 12 months
measure: Number of Participants Who Achieved Neurological Success
timeFrame: 3, 6, and 12 months
measure: Number of Participants Who Underwent Secondary Surgery at Index Level
timeFrame: 3, 6, and 12 months
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Todd H. Lanman, M.D., INC.
state: California
city: Royal Oak
country: United States
facility: Beaumont Hospital
state: Michigan
city: Portland
country: United States
facility: Kellogg M.D., Brain & Spine
state: Oregon
city: West Columbia
country: United States
facility: Lexington Brain and Spine
state: South Carolina
Study officials:
References: