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

Degeneration of Lumbar Intervertebral Disc Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01491373
• Other study ID #: C-9504
• Status: Completed
• Phase: N/A
• First received: December 12, 2011
• Last updated: August 1, 2013
• Start date: January 1997
• Est. completion date: September 1999

Study information

• Verified date: December 2011
• Source: Medtronic Spinal and Biologics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: September 1999
• Est. primary completion date: September 1999
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Degeneration of Lumbar Intervertebral Disc
• Intervertebral Disc Degeneration

Intervention

Device:
• rhBMP-2/ACS/LT-CAGE® Device
rhBMP-2/ACS inserted into Sofamor Danek's LT-CAGE® device.
• Autograft/LT-CAGE® Device
LT-CAGE® device filled with autogenous bone taken from the patient's iliac crest

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Spinal and Biologics

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fusion		24 month	No
Secondary	Pain Assessment (Oswestry Disability Index, ODI)		24 month	No
Secondary	Neurological Status Assessment		24 month	Yes
Secondary	Health status assessment (SF-36)		24 month	No