Rocky Mountain Associates in Orthopaedic Medicine Newport Beach, California, United States, 92660

Los Angeles, California, United States, 90045 Huntsville, Alabama, United States, 35801ĭaly City, California, United States, 94015 Has any disease that would preclude accurate clinical evaluation.Has history of any endocrine or metabolic disorder known to affect osteogenesis.Has history of allergy to bovine products or a history of anaphylaxis.Has received any previous exposure to any/all BMP's of either human or animal extraction.Has received treatment with an investigational therapy within 30 days prior to implantation surgery or treatment is planned during 24 months following the implantation surgery.Has history of hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins) or collagen.Has history of exposure to injectable collagen implants.Has received drugs that may interfere with bone metabolism within 2 weeks prior to the surgery date, excluding routine perioperative, non-steroidal anti-inflammatory drugs.Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse.Has chronic or acute renal and/or hepatic failure or prior history of renal and/or hepatic parenchymal disease.Has a Waddell Signs of Inorganic Behavior score of 3 or greater.Has documented metal allergy, titanium alloy intolerance or cobalt-chrome-molybdenum alloy.Has presence or prior history of malignancy (except for basal cell carcinoma of skin).Has overt or active bacterial infection, either local or systemic and/or potential for bacteremia.Does not include low dose aspirin for prophylactic anticoagulation Has a condition that requires postop medications that interfere with fusion, such as steroids or prolonged use of non-steroidal anti-inflammatory drugs, excluding routine perioperative, non-steroidal anti-inflammatory drugs.Has fever (temp > 101☏ oral) at time of surgery.If level of BMD is -3.5 or lower or -2.5 or lower with vertebral crush fracture, the patient is excluded Has any of the following that may be associated with a diagnosis of osteoporosis (if Yes, a DEXA Scan is required): Postmenopausal Non-Black female over 60 yrs of age and weighs less than 140 pounds Postmenopausal female that has sustained a non-traumatic hip, spine or wrist fracture Male over the age of 60 that has sustained a non-traumatic hip or spine fracture.Level treated has fractures secondary to trauma.Has rotatory scoliosis at involved level.Has any posterior element insufficiency.Has severe pathology of facet joints of involved vertebral bodies.

Requires spinal fusion and/or arthroplasty at more than 1 lumbar level.Had previous anterior lumbar spinal surgery at involved level.Had prior posterior lumbar surgery resulting in significant muscle/ligament morbidity, not including facet saving techniques.

Had previous posterior lumbar spinal fusion surgical procedure at involved level.

Has primary diagnosis of a spinal disorder other than DDD at involved level.

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

If child-bearing potential, patient is non-pregnant, non-nursing, and agrees not to become pregnant for 1 yr after surgery.

Has not responded to non-operative treatment for 6 mos.

Age 18 to 70 yrs who are skeletally, mature, inclusive.

Has intact facet joints at the involved vertebral levels documented by CT and/or MRI.

Has single-level symptomatic degenerative involvement from L4-S1 requiring surgical treatment.

Has 1 or more of the following documented by CT, MRI, or plain x-rays: modic changes, high intensity zones in the annulus, loss of disc height, decreased hydration of the disc.

Has DDD as noted by back pain of discogenic origin, with or without leg pain, with degeneration of the disc confirmed by patient history.

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