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In This Section Texas Health Research & Education Institute

Clinical Trials

Disease or Condition   Orthopedics / Spine
Title   ARTIFICIAL CERVICAL DISC-LP AT A SINGLE LEVEL (Orthopedics / Spine)
Description   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.
IRB Number   Pro159
Inclusion/Notes   INCLUSION:
  • 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.

EXCLUSION:
  • 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;
  • Is pregnant;
  • 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.
Status   Active - not Recruiting
Location   Texas Health Harris Methodist Hospital Hurst-Euless-Bedford
Principal Name    Rebecca Elizabeth Stachniak MD
Contact Name   Jennifer Dunkin
Phone   (972) 943-9779

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