In This SectionTexas Health Research & Education Institute
Disease or Condition
Orthopedics / Spine
ARTIFICIAL CERVICAL DISC-LP AT A SINGLE LEVEL (Orthopedics / Spine)
The purpose of this study is to evaluate the safety and effectiveness of the ACD-LP for the single-level surgical treatment of cervical (neck) disc disease in your spine. The ACD-LP is designed to replace the removed disc in your neck, and is intended to provide motion of your cervical spine at the treated level.
Cervical degenerative disc disease defined as:
a. intractable radiculopathy and/or
b.myelopathy with at least one of the following items producing symptomatic nerve root and/or spinal cord compression that is documented by patient history [(e.g., pain, functional deficit, and/or neurological deficit radiographic studies (e.g., CT, MRI, x-rays, etc.).
i. herniated disc.
ii. osteophyte formation; One level requiring surgical treatment; C3-C4 disc to C6-C7 disc level of involvement.
Unresponsive to nonoperative treatment for approximately six weeks or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued nonoperative management;
No previous surgical intervention at the involved level or any subsequent, planned/staged surgical procedure at the involved or adjacent level(s);
Is at least 18 years of age, inclusive, at the time of surgery.
Preoperative Neck Disability Index score ~ 30.
Has a preoperative neck pain score of ~ 20 based on the Preoperative Neck and Arm Pain Questionnaire.
If a female of child-bearing potential, patient is not pregnant, at the time of surgery.
ls willing to comply with the study plan and sign the Patient Informed Consent Form.
Has a cervical spinal condition other than symptomatic cervical disc disease requiring surgical treatment at the involved level.
Documented or diagnosed cervical instability defined by dynamic (flexion/extension) radiographs showing:
a) Sagittal plane translation> 3.5 mm or
b) Sagittal plane angulation> 20°.
More than one cervical level requiring surgical treatment;
Has a fused level adjacent to the level to be treated;
Has severe pathology of the facet joints of the involved vertebral bodies;
Previous surgical intervention at the involved level;
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):
a) Postmenopausal non-Black female over 60 years of age and weighs less than 140 pounds.
b) Postmenopausal female that has sustained a non-traumatic hip, spine, or wrist fracture.
c) Male over the age of 70.
d) Male over the age of 60 that 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 severe insulin dependent diabetes;
Has chronic or acute renal failure or prior history of renal disease;
Has fever (temperature> 101°F oral) at the time of surgery;
Has a documented allergy to stainless steel, titanium, or a titanium alloy;
ls mentally incompetent (If questionable, obtain psychiatric consult);
ls a prisoner;
ls an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse;
Has received drugs which 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 a history of 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), excluding 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 Artificial Cervical Disc-LP implantation.
Active - not Recruiting
Texas Health Harris Methodist Hospital Hurst-Euless-Bedford