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In This Section Texas Health Research & Education Institute

Clinical Trials

Disease or Condition   Orthopedics / Spine
Title   Infuse bone graft with Peek Interbody spacer and an Anterior Cervical Plate in Patients with Cervical Degenerative Disc (Orthopedics / Spine)
Description   Infuse bone graft with spacer for patients with cervical degernerative disc disease at any single level.
IRB Number   Pro302
Inclusion/Notes   INCLUSION:
  • Has single-level cervical degenerative disc disease (from C3-C7) requiring surgical treatment and involving intractable radiculopathy and/or myelopathy.

  • Has a herniated disc and/or osteophyte formation at the 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 by radiographic studies (e.g., CT, MRI, x-rays).
  • Has been unresponsive to non-operative treatment for six weeks or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative management.

  • Is at least 18 years of age and skeletally mature at the time of surgery.

  • Has a preoperative Neck Disability Index (NDI) score =30.

  • Has a preoperative neck pain score (pain intensity + pain frequency) =8 (out of 20) based on the preoperative Neck and Arm Pain Questionnaire.

  • If a female of childbearing potential, patient is not pregnant or nursing and agrees not to become pregnant for one year following surgery.

  • Is willing and able to comply with the study plan and able to understand and sign the Patient Informed Consent Form.

EXCLUSION:
  • Has a cervical spinal condition other than symptomatic cervical degenerative disc disease requiring surgical treatment at the involved level.

  • Has documented or diagnosed cervical instability at the target level, defined by dynamic (flexion/extension) radiographs showing:
    a) Sagittal plane translation > 3.5 mm, or
    b) Sagittal plane angulation > 20°.

  • Has had previous surgical intervention at the involved level.

  • Has any subsequent planned/staged surgical procedure at the involved or adjacent level(s).

  • Has a fused level adjacent to the level to be treated.

  • Has severe pathology of the facet joints of the involved vertebral bodies.

  • Has any of the following (If “Yes” to any of the below risk factors, a DEXA Scan will be required to determine eligibility.):
    a) Previous diagnosis of osteoporosis, osteopenia, or osteomalacia.
    b) Postmenopausal female over 60 years of age who weighs less than 140 pounds.
    c) Postmenopausal female who has sustained a non-traumatic hip, spine, or wrist fracture.
    d) Male over the age of 70.
    e) Male over the age of 60 who has sustained a non-traumatic hip or spine fracture.
    If the level of DEXA T-score is -3.5 or lower (i.e., -3.6, -3.7, etc.) or is -2.5 or lower (i.e., -2.6, -2.7, etc.) with a history of a vertebral crush fracture, the patient is excluded from the study.

  • Has presence of active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin).

  • Has overt or active bacterial infection, either local or systemic.

  • Has insulin dependent diabetes.

  • Has chronic or acute renal failure or prior history of renal disease.

  • Has a documented allergy or intolerance to stainless steel, titanium, titanium alloy, polyetheretherketone (PEEK), or tantalum.

  • Is mentally incompetent. (If questionable, obtain psychiatric consult.)

  • Is a prisoner.

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

  • Has been on oral or injectable steroids for 6 weeks or more at the time of enrollment. (This does not include episodic steroid use; inhaled steroids; steroid medication [e.g., Epidural Steroid Injections, Medrol Dose Paks, etc.] within two weeks of surgery, specifically for the perioperative management of cervical disc disease symptoms; or routine perioperative anti-inflammatory drugs.)

  • Has a history of autoimmune disease. (Refer to Section IV.A.3 of this Clinical Investigational Plan for additional information.)

  • Has a history of exposure to injectable collagen or silicone implants.

  • Has a history of hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins) or collagen.

  • Has received any previous exposure to any/all BMPs (INFUSE Bone Graft, OP-1, etc.) of either human or animal extraction.

  • Has a history of allergy to bovine products.

  • Has a history of any allergy resulting in anaphylaxis.

  • Has a 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; routine perioperative drugs; episodic steroid use; inhaled steroids, etc.)

  • Has received treatment with an investigational therapy (drug, device, or biologic) within 28 days prior to implantation surgery or such treatment is planned during the 24-month period following the study surgery.

  • NOTE: If a patient does not meet the entry criteria during the initial enrollment, the patient should not be re-evaluated for entry into the study at a later time.
Status   Active - not Recruiting
Location   Texas Health Presbyterian Hospital Plano
Principal Name    Rebecca Elizabeth Stachniak MD
Contact Name   Jennifer Dunkin
Phone   (972) 943-9779

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