Spine Fusion Instrumented With BMP-2 vs Uninstrumented With Infuse BMP-2 Alone

NCT00405600 | Completed

• 1 other identifier: CDHA016
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of spinal fusion is to relieve pain and/or increase stability in painful or unstable spine joints. A patient may or may not receive rods and screws with the use of bone graft materials to facilitate bone growth and a fusion thus preventing movement of the bones of the spine. In this research study, bone graft substitute material called Bone Morphogenetic Protein-2 known as BMP-2 Infuse will be used. No hip bone will be used. The surgical procedure will consist of BMP-2 Infuse with or without the use of rods and screws.

Conditions

Degenerative Lumbar Disc Disease; Spondylolisthesis; Spinal Stenosis

Keywords

Lumbar degenerative disease; spinal stenosis; spondylolisthesis; non instrumented surgery; instrumented surgery; BMP-2

Outcome Measures

Primary Outcomes (3)

• To evaluate bone fusion;

  3mon., 6mon., 12mon., 24mon

• Radiology tests; CT spine 24mon.

  3mon., 6mon., 12mon., 24mon

• Clinical neurological evaluations; patient questionnaires

  3mon., 6mon., 12mon., 24mon

Secondary Outcomes (2)

• Hospital and surgical data

  hospitalization;

• Adverse events

  hospitalization, clinic visits, unscheduled visits

Study Arms (1)

Device

ACTIVE COMPARATOR

Device used in surgery with or without instrumentation

Procedure: Device used in surgery with or without instrumentation

Interventions

Device used in surgery with or without instrumentation PROCEDURE

Infuse Bone Graft BMP-2, Large Kit will be used in all surgeries. Spine surgeries will be either instrumented or uninstrumented.

Device

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient not currently participating in a drug or medical clinical trial.
• Patient signed informed consent.
• Patient is willing to be available for each examination scheduled over the study duration.
• Patient has clinical and radiologic history of degenerative disc disease or spondylolisthesis (no greater than grade 1 utilizing Meyerding's classification (Meyerding HW, 1932)); spinal stenosis for which conservative treatment has failed and lumbar spinal fusion is indicated.
• Eligible for non-instrumented or instrumented surgical procedure
• Has one or two levels (contiguous) involvement from L1-S1 requiring fusion
• Has preoperative Oswestry score greater than 30
• Has not responded to non-operative treatment for a period of 6 months (bed rest, physical therapy, medication, manipulations, spinal injections, other).
• Is at least 20 years of age inclusive at the day of surgery
• If female of childbearing potential, patient is non-pregnant, non-nursing, and agrees to use adequate contraception for one year following surgery.

You may not qualify if:

• Patient has a systemic infection.
• Patient has had more than one previous non-fusion spinal surgery at the involved level.
• Patient requires fusion at more than 2 levels.
• Patient has pseudoarthroses from a previous fusion attempt.
• Patient has highly communicable diseases, inflammatory or autoimmune disease (e.g.osteomyelitis, crohn's, rheumatoid arthritis, systemic lupus, gout, HIV/AIDS, active tuberculosis, venereal disease, active hepatitis). A note to file written by the investigator will permit a patient into the study who experiences a mild case which will not affect the outcome of the study.
• Has been previously diagnosed with osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated
• Patient has a significant medical history that, in the Investigator's opinion would not make them a good study candidate.
• Patient requires interbody cage fusion or non-pedicle screw instrumentation.
• Pregnancy.
• Has presence of active malignancy (except basal cell carcinoma of the skin)
• Has a history of severe allergy (anaphylaxis)
• Is grossly obese, i.e. weight over 40% over ideal for their height and age.
• Has a fever (temperature over 101 F oral)
• Has an allergy to the BMP-2
• Has allergy to bovine products

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

Capital Health Health Authority, QEII Health Sciences Centre, Halifax Infirmary site,

Halifax, Nova Scotia, B3H-3A7, Canada

Location

MeSH Terms

Conditions

Spondylolisthesis; Spinal Stenosis

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Spondylolysis; Spondylosis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Dr. David Alexander, M.D.

  Capital Health District Authority, Centre for Clinical Research, Queen Elizabeth II, Health Sciences Centre, 1278 Tower Rd.,Halifax, Nova Scotia, B3H-9Z9, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 28, 2006
• First Posted: November 30, 2006
• Study Start: November 1, 2006
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: February 15, 2013

Record last verified: 2013-02

Locations

CA (1)