Clinical trial NCT01494428: A Pilot Study of rhBMP-2/ACS/Allograft Bone Dowel for Anterior Lumbar Interbody Fusion in Patients With Symptomatic Degenerative Disc Disease
Official title: A Clinical Investigation of Recombinant Human Bone Morphogenetic Protein-2 and Absorbable Collagen Sponge With Allograft Bone Dowel for Anterior Lumbar Interbody Fusion in Patients With Symptomatic Degenerative Disc Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Degenerative Disc Disease
Keywords: symptomatic degenerative disc disease
Lead sponsor: Medtronic Spinal and Biologics
Sponsor class: INDUSTRY
First posted: 2011-12-19
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot clinical trial is to evaluate the device design as a method of facilitating spinal fusion.


Eligibility criteria: 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 \[leg, back, or symptoms in the sciatic nerve distribution\], function deficit and/or neurological deficit)and radiographic studies ( e.g., CT, MRl, X-Ray, etc.) to include one or more of the following:

   * instability( defined as angular motion \> 5° and/or translation \>= 2-4mm, based on Flex/Ext radiographs);
   * osteophyte formation;
   * decreased disc height;
   * thickening of ligamentous tissue;
   * disc degeneration or herniation; and/or
   * facet joint degeneration.
2. Has preoperative Oswestry score \> 35.
3. Has no greater than Grade 1 spondylolisthesis utilizing Meyerding's Classification (Meyerding HW, 1932.).
4. Has single-level symptomatic degenerative involvement from L4 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 at least 6 months.
7. If female of child-bearing potential, who is not pregnant or nursing, and who agrees to use adequate contraception for 16 weeks following surgery.
8. Is willing and able to comply with the study plan and sign the Patient Informed Consent Form.

Exclusion Criteria:

1. Had previous anterior spinal fusion surgical procedure at the involved level.
2. Has a condition which requires postoperative medications that interfere with fusion, such as steroids or nonsteroidal antiinflammatory drugs (this does not include low dose aspirin for prophylactic anticoagulation).
3. Has osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated.
4. Has presence of active malignancy.
5. Has overt or active bacterial infection, either local or systemic.
6. Is obese, i.e., weight greater than 40% over ideal for their age and height.
7. Has fever (temperature\> 101° F oral) at the time of surgery.
8. Is mentally incompetent. If questionable, obtain psychiatric consult.
9. Has a Waddell Signs of Inorganic Behavior score of 3 or greater.
10. Is a prisoner.
11. Is an alcohol and/or drug abuser.
12. Is a tobacco user at the time of surgery.
13. 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).
14. Patient has a history of autoimmune disease (Systemic Lupus Erythematosus or Dermatomyositis).
15. Patient has a history of exposure to injectable collagen implants.
16. Patient's history includes hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins) or collagen.
17. 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.
18. Patient has received any previous exposure to BMP.
19. Patient has a history of severe allergy, an allergy to bovine products, or a history of anaphylaxis.
20. 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).

Primary outcomes:
measure: Severity and Rate of Implant-Associated Adverse Events
timeFrame: 24 month
measure: Rate of Implant Revision, Removal and Supplemental Fixation Procedures
timeFrame: 24 month
measure: Incidence of Permanent Adverse Events
timeFrame: 24 month
measure: Fusion
timeFrame: 24 month
measure: Disc Height Measurement
timeFrame: 24 month
measure: Pain/Disability Status
timeFrame: 24 month
measure: Neurological Status
timeFrame: 24 month
Secondary outcomes:
measure: Nature and Frequency of Adverse Events Not Associated with the Implants
timeFrame: 24 month
measure: Rate of Reoperation Procedures
timeFrame: 24 month
measure: Hip (Donor Site) Pain Status
timeFrame: 24 month
measure: Patient Satisfaction/Quality of Life Status (SF-36)
timeFrame: 24 month
measure: Pain Status (Numerical Rating Scale)
timeFrame: 24 month
measure: Overall Success
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
References: