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Active Clinical Trials

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

Active NCT:
03062657
Allegheny General Hospital
Allegheny General Hospital

Category:
Brain and Nerve
Sponsor: 
Medtronic Spinal and Biologics
Contact: 

For more information, please contact Dawn Skirpan at 412-359-4604 or Dawn.Skirpan@ahn.org.

An Investigation of The Metal Concentration In Patients Implanted With The Prestige LP™ Cervical Disc At Two Contiguous Levels In The Cervical Spine

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.

Ages Eligible for Study:  18 Years and older   (Adult, Senior)

Sexes Eligible for Study:  All

Accepts Healthy Volunteers:  No

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 or contiguous levels;

Has preoperative Neck Disability Index (NDI) score ≥ 30;

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 a fused level contiguous to the levels to be treated;

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 or adjacent 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 insulin dependent diabetes;

Is a tobacco user who does not agree to suspend smoking prior to surgery;

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;

Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and /or drug abuse;

Is involved with current or pending litigation regarding a spinal condition;

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.

Has had a procedure requiring the use of permanent metal implants [i.e., stents, joint replacement, and/or dental implants (does not include fillings, crowns, or braces)];

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).

Is currently working in a profession with increased exposure to metal particles (i.e., jewelry making, construction, iron working, metal grinding, welding, mining etc.).

Is currently receiving B12 injections and/or taking nutritional supplements and/or vitamins containing titanium, vanadium, and aluminum based ingredients.