Clinical trial NCT01495234: Pilot Study of rhBMP-2/BCP in Patients With Spinal Degeneration With Instability Requiring Surgical Fusion
Official title: A Pilot Investigation of Recombinant Human Bone Morphogenetic Protein- 2/Biphasic Calcium Phosphate in Patients With Spinal Degeneration With Instability Requiring Surgical Fusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Degenerative Disc Disease
Keywords: Spinal degeneration
Lead sponsor: Medtronic Spinal and Biologics
Sponsor class: INDUSTRY
First posted: 2011-12-19
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to generate data relating to patient safety, bone generating activity associated with the use of the rhBMP-2/BCP device as compared to autograft and to evaluate the feasibility of conducting a larger clinical trial in a patient population requiring spinal fusion.


Eligibility criteria: Inclusion Criteria:

* Subject has radiographically documented spinal degeneration with instability as documented by the presence of translation \>= 4mm or angulation \>= 5°.
* Subject has intractable back pain which does not respond to conservative treatment and in the investigator's opinion, requires surgical spinal fusion.
* Subject's pain is predominantly associated with the back.
* Subject has only one level involvement at L3-L4, L4-L5, or L5-S1.
* Subject is 18 years of age or greater at the time consent is given to participate in the study.
* Subject is willing to comply with the study plan and sign the informed consent.
* Subject is male or a non-pregnant, non-nursing female. All females of child-bearing age must agree to use adequate contraception for a period of no less than 16 weeks following surgery.

Exclusion Criteria:

* Subject has primary spinal diagnosis of a disorder other than spinal degeneration with instability at the involved surgical level.
* Subject has spinal stenosis or condition which requires a full laminectomy procedure.
* Subject has had a previous fusion, discectomy or laminectomy procedure at L3-L4, L4-L5 or L5-S1.
* Subject has received drugs which may interfere with bone metabolism within two weeks prior to the planned date of spinal fusion surgery (e.g., steroids, methotrexate) or has a condition which requires postoperative medications that interfere with fusion (e.g., steroids, nonsteroidal antiinflammatory drugs, or methotrexate).
* Subject has overt or active infection near the operative spinal region.
* Subject has active systemic infection.
* Subject has history of autoimmune disease (Systemic Lupus Erythematosus or Dermatomyositis).
* Subject's history includes hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins).
* Subject 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/BCP implantation.
* The subject requires electrical bone growth stimulation, allograft, or bone substitute as part of treatment.
* Subject has history of endocrine or metabolic disorder known to affect osteogenesis (e.g. Paget's disease, renal osteodystrophy, Ehlers Danlos syndrome, or osteogenesis imperfecta).
* Subject has a known diagnosis of diabetes which requires treatment with medication.
* Subject has received previous radiation therapy at the site to be fused.
* Subject is unwilling to return for required follow-up visits.
* Subject is a prisoner.
* Subject has insufficient bone mass which precludes surgery (e.g., severe osteopenia or osteoporosis).

Primary outcomes:
measure: Fusion Status
timeFrame: 12 month
Secondary outcomes:
measure: Oswestry Low Back Pain Disability Questionnaire Status
timeFrame: 12 month
measure: Neuro/Functional Status
timeFrame: 12 month
measure: Neurological Status
timeFrame: 12 month
measure: General Health Status (SF-36)
timeFrame: 12 month
Other outcomes:
Locations:
Study officials:
References: