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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03062657
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Medtronic Spinal and Biologics
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Cervical Degenerative Disc Disease, Radiculopathy, Myelopathy
Arms & Interventions

Arms

Experimental: PRESTIGE LP

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

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Todd H. Lanman, M.D., INC., Beverly Hills, California

Status

Recruiting

Address

Todd H. Lanman, M.D., INC.

Beverly Hills, California, 90210

Site Contact

Deborah Devlin

[email protected]

310-385-7766

Beaumont Hospital, Royal Oak, Michigan

Status

Recruiting

Address

Beaumont Hospital

Royal Oak, Michigan, 48073

Site Contact

Lisa Motowski

[email protected]

248-551-6679

Kellogg M.D., Brain & Spine, Portland, Oregon

Status

Recruiting

Address

Kellogg M.D., Brain & Spine

Portland, Oregon, 97806

Site Contact

Lisa Kellogg

[email protected]

503-256-1462 #3

Allegheny General Hospital, Pittsburgh, Pennsylvania

Status

Withdrawn

Address

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212

Lexington Brain and Spine, West Columbia, South Carolina

Status

Recruiting

Address

Lexington Brain and Spine

West Columbia, South Carolina, 29169

Site Contact

Denise Seymour

[email protected]

803-935-8410