In This SectionTexas Health Research & Education Institute
Disease or Condition
Orthopedics / Spine
Infuse bone graft with Peek Interbody spacer and an Anterior Cervical Plate in Patients with Cervical Degenerative Disc (Orthopedics / Spine)
Infuse bone graft with spacer for patients with cervical degernerative disc disease at any single level.
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.
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.