INFUSE® Bone Graft and MASTERGRAFT® Granules With CD HORIZON® for Posterolateral Lumbar Fusion in Patients With Degenerative Disc Disease - Pilot Study

A Pilot Prospective Randomized Clinical Investigation of INFUSE® Bone Graft and MASTERGRAFT® Granules With the CD HORIZON® Spinal System for Posterolateral Lumbar Fusion in Patients With Symptomatic Degenerative Disc Disease

The purpose of this pilot clinical trial is to evaluate the feasibility of using the investigational implant (INFUSE® Bone Graft and MASTERGRAFT® Granules with the CD HORIZON® Spinal System) as a method of facilitating spinal fusion in patients with symptomatic degenerative disc disease.

Inclusion Criteria:

1. Has degenerative disc disease as noted by back pain of discogenic origin, with or without leg pain, with degeneration of the disc confirmed by patient history (e.g., pain [leg, back, or symptoms in the sciatic nerve distribution], functional deficit and/or neurological deficit) and radiographic studies (e.g.,C T, MRl, X-Ray,etc.) to include one or more of the following:

   • instability (defined as angulation ≥ 5° and/or translation ≥ 4mm,based on flexion/extension radiographs);
   • osteophyte formation;
   • decreased disc height;
   • thickening of ligamentous tissue;
   • disc degeneration or herniation; and/or
   • facet joint degeneration.

2. Has preoperative Oswestry score ≥ 30.

3. Has no greater than Grade 1 spondylolisthesis utilizing Meyerding's Classification (Meyerding HW,1932).

4. Requires fusion of a single level disc space from L1 to S1.

5. Is at least 18 years of age, inclusive, at the time of surgery.

6. Has not responded to non-operative treatment (e.g., bed rest, physical therapy, medications, spinal injections, manipulation, and/or TENS) for a period of 6 months.

7. If of child-bearing potential, patient is non-pregnant,non-nursing,and agrees to use adequate contraception for 1 year following surgery.

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

Exclusion Criteria:

1. Has primary diagnosis of a spinal disorder other than degenerative disc disease with Grade 1 or less spondylolisthesis at the involved level.

2. Had previous spinal fusion surgical procedure at the involved level or an adjacent level.

3. Requires spinal fusion at more than one lumbar level.

4. Has a condition which requires postoperative medications that interfere with fusion, such as steroids or prolonged use of nonsteroidal anti-inflammatory drugs. This does not include low dose aspirin for prophylactic anticoagulation.

5. Has a documented history of osteopenia or osteomalacia.

6. Has any of the following that may be associated with diagnosis of osteoporosis (if "Yes" to any of the below risk factors,a dual x-ray absorptiometry (DEXA) scan will be required to determine eligibility.)

   • Postmenopausal non-black female over 60 years 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 70.
   • 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 a T score of -2.5 with vertebral crush fracture,then the patient is excluded from the study.

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

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

9. Has a documented titanium alloy allergy or intolerance.

10. Is mentally incompetent. If questionable, obtain psychiatric consult.

11. Has a 'Waddell Signs of Inorganic Behavior'score of 3 or greater.

12. Is a prisoner.

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

14. ls a tobacco user at the time of surgery.

15. Has received drugs which may interfere with bone metabolism within two weeks prior to the planned date of spinal fusion surgery (e.g., steroids or methotrexate).

16. Has a documented history of autoimmune disease ( e.g. Systemic Lupus Erythematosus or dermatomyositis).

17. Has a history of exposure to implanted collagen or silicone implants.

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

19. Has received treatment with an investigational therapy within 28 days prior to implantation surgery or such treatment is planned during the 16 weeks following rhBMP-2/ACS/MASTERGRAFT® Granules implantation.

20. Has received any previous exposure to any/all BMP's of either human or animal extraction.

21. Has a history of allergy to bovine products or a history of anaphylaxis.

22. 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).