Pilot Study of rhBMP-2/ACS/LT-CAGE® for Anterior Lumbar Interbody Fusion in Patients With Degenerative Disc Disease

A Feasibility Investigation of Recombinant Human Bone Morphogenetic Protein-2 and Absorbable Collagen Sponge With LT-CAGE® Device for Anterior Lumbar Interbody Fusion in Patients With Degenerative Disc Disease

This study is designed to evaluate the feasibility of recombinant human bone morphogenetic protein-2 and absorbable collagen sponge with the tapered interbody fusion device (LT-CAGE® ) for anterior lumbar interbody fusion in patients with degenerative disc disease.

Study Overview

• Status: Completed
• Conditions: Degeneration of Lumbar Intervertebral Disc
• Intervention / Treatment: Device: rhBMP-2/ACS/LT-CAGE® Device; Device: Autograft/LT-CAGE® Device

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Has degenerative disc disease as noted by back pain of discogenic origin with degeneration of the disc confirmed by radiographic studies.
2. Has no greater than Grade 1 spondylolisthesis utilizing Meyerding's Classification (Meyerding HW, 1932.)
3. Has single level symptomatic degenerative involvement from L2 to S1.
4. Is between the ages of 18 and 65, inclusive, at the time of surgery.
5. Is willing to comply with the study plan and sign the Patient Informed Consent Form.
6. Has not responded to conservative treatment for a period of 5 months.
7. If of child-bearing potential, subject is non-pregnant (documented by a negative Pregnancy test within 72 hours of surgery), non-nursing female who agrees to use adequate contraception for 16 weeks following surgery

Exclusion Criteria:

1. Has spinal condition other than symptomatic degenerative disc disease at the involved surgical level.
2. Had previous anterior surgical procedures at the involved spinal level.
3. Has a condition which requires postoperative medications that interfere with fusion such as steroids or nonsteroidal anti-inflammatory drugs. (This does not include low dose aspirin for prophylactic anticoagulation.)
4. Has osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated.
5. Has circulatory problems, such as thrombophlebitis, lymphedema, or vascular deficiency at the implant site.
6. Has symptomatic cardiac disease.
7. Has presence of active malignancy or history of cancer in the past 5 years.
8. Has overt or active infection.
9. Is obese, i.e., weight greater than 40% over ideal for their age and height.
10. Has fever (temperature > 101°F oral).
11. Has local inflammatory signs indicative of infection.
12. Has a documented metal allergy or intolerance.
13. Is involved in a worker's compensation or unresolved spinal litigation case.
14. Is mentally incompetent (either documented or in the opinion of the investigator).
15. Has psychogenic magnification of pain (in the opinion of the investigator).
16. Is a prisoner.
17. Is pregnant.
18. Is an alcohol and/or substance abuser.
19. Requires bone growth stimulation in the lumbar spine.
20. Is a tobacco user at the time of surgery.
21. Patient 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).
22. Patient has a history of autoimmune disease (systemic lupus erythematosus or dermatomyositis).
23. The subject has a history of exposure to injectable collagen implants.
24. Patient's history includes hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins) or collagen.
25. Patient 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 implantation.
26. Patient has received any previous exposure to BMP.
27. The patient requires allograft or bone substitute as part of treatment.
28. Patient has history of endocrine or metabolic disorder known to affect osteogenesis (e.g. Paget's disease, renal osteodystrophy, Ehlers-Danlos syndrome, or osteogenesis imperfecta).
29. Patient in the physician's opinion, would not be a good candidate for this surgical procedure.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: rhBMP-2/ACS	Device: rhBMP-2/ACS/LT-CAGE® Device; rhBMP-2/ACS inserted into Sofamor Danek's LT-CAGE® device.; Other Names: Recombinant human bone morphogenetic protein-2
Active Comparator: Autograft	Device: Autograft/LT-CAGE® Device; LT-CAGE® device filled with autogenous bone taken from the patient's iliac crest; Other Names: Autogenous bone graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Fusion	24 month

Secondary Outcome Measures

Outcome Measure	Time Frame
Pain Assessment (Oswestry Disability Index, ODI)	24 month
Neurological Status Assessment	24 month
Health status assessment (SF-36)	24 month

Collaborators and Investigators

• Sponsor: Medtronic Spinal and Biologics

Study record dates

Study Major Dates

• Study Start: January 1, 1997
• Primary Completion (Actual): September 1, 1999
• Study Completion (Actual): September 1, 1999

Study Registration Dates

• First Submitted: December 12, 2011
• First Submitted That Met QC Criteria: December 12, 2011
• First Posted (Estimate): December 14, 2011

Study Record Updates

• Last Update Posted (Estimate): August 2, 2013
• Last Update Submitted That Met QC Criteria: August 1, 2013
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: Degenerative Disc Disease; Symptomatic Degenerative Disc Disease
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: C-9504