Clinical trial NCT00707265: rhBMP-2/CRM/CD HORIZON® Spinal System Pivotal Study
Official title: A Prospective, Randomized Clinical Investigation of rhBMP-2 and Compression Resistant Matrix With the CD HORIZON® Spinal System for Posterolateral Lumbar Fusion in Patients With Symptomatic Degenerative Disc Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Degenerative Disc Disease
Lead sponsor: Medtronic Spinal and Biologics
Sponsor class: INDUSTRY
First posted: 2008-06-30
Enrollment: 463
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 study was to evaluate the rhBMP-2/CRM/CD HORIZON® Spinal System as a method of facilitating spinal fusion in patients with degenerative disc disease.

Detailed description: This clinical trial was conducted to evaluate the rhBMP-2/CRM/CD HORIZON® Spinal System for posterolateral fusion treatment of patients with symptomatic degenerative disc disease versus the control group of autogenous bone with the CD HORIZON® Spinal System.

The investigational treatment was the open bilateral posterolateral implantation of the rhBMP-2/CRM/CD HORIZON® Spinal System. One investigational implant was placed across two adjacent transverse processes on each side of the spine during the spinal fusion procedure.

The control treatment was the bilateral posterolateral implantation of the autogenous bone harvested from the iliac crest with the CD HORIZON® Spinal System.

Eligibility criteria: Inclusion Criteria:

Each patient participating in this clinical trial must meet all of the following 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 of pain and radiographic studies:
2. Requires fusion of a single level disc space from L1 to S1.
3. Has not responded to non-operative treatment (e.g., bed rest, physical therapy, medications, spinal injections, manipulation, and/or TENS) for a period of 6 months.
4. If of child-bearing potential, patient is non-pregnant, non-nursing, and agrees to use adequate contraception for 1 year following surgery.

Exclusion Criteria:

A patient meeting any of the following criteria is to be excluded from this clinical trial:

1. Has primary diagnosis of a spinal disorder other than degenerative disc disease with Grade 1 or less spondylolisthesis at the involved level.
2. Had previous spinal fusion surgical procedure at the involved level.
3. Requires spinal fusion at more than one lumbar level.
4. Has been previously diagnosed with osteopenia.
5. Has presence of active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin).
6. Has a history of autoimmune disease (e.g. Systemic Lupus Erythematosus or dermatomyositis).
7. Has a history of exposure to injectable collagen or silicone implants.
8. 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/CRM implantation.
9. Has received any previous exposure to any/all BMP's of either human or animal extraction.

Primary outcomes:
measure: Overall Success
timeFrame: 24 months
Secondary outcomes:
measure: Fusion
timeFrame: 24 months
measure: Pain/Disability Status
timeFrame: 24 months
measure: Overall Neurological Status
timeFrame: 24 months
measure: General Health Status
timeFrame: 24 months
measure: Back Pain
timeFrame: 24 months
measure: Leg Pain
timeFrame: 24 months
measure: Operative Time
timeFrame: At the time of operation
measure: Blood Loss
timeFrame: At the time of operation
measure: Hospital Days
timeFrame: At the time of discharge
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurosurgical Associates
state: Arizona
city: Orange
country: United States
facility: Orthopaedic Specialty Institute
state: California
city: Santa Monica
country: United States
facility: UCLA Orthopedic Hospital
state: California
city: Washington
country: United States
facility: Georgetown University Dept. of Orthopaedic Spine Surgery
state: District of Columbia
city: Melbourne
country: United States
facility: Brevard Orthopaedic Clinic, Inc.
state: Florida
city: Tampa
country: United States
facility: Florida Ortho Institute
state: Florida
city: Winter Park
country: United States
facility: Florida Neurological Consultants
state: Florida
city: Columbus
country: United States
facility: The Hughston Clinic P.C.
state: Georgia
city: Hoffman Estates
country: United States
facility: Barrington Orthopedic Specialists
state: Illinois
city: Park Ridge
country: United States
facility: Lutheran Spine Center
state: Illinois
city: Carmel
country: United States
facility: The Spine Institute
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinics
state: Iowa
city: West Des Moines
country: United States
facility: Des Moines Orthopaedic Surgeons
state: Iowa
city: Louisville
country: United States
facility: Spine Institute
state: Kentucky
city: Baltimore
country: United States
facility: Alvin & Lois Lapidus Cancer Insitute
state: Maryland
city: Southfield
country: United States
facility: Jeffrey S. Fischgrund
state: Michigan
city: Melville
country: United States
facility: Orthopedic Spine Care of Long Island, PC
state: New York
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
city: Tulsa
country: United States
facility: Central States Orthopedic Specialists
state: Oklahoma
city: Medford
country: United States
facility: Medford Neurological & Spine Clinic
state: Oregon
city: Wyomissing
country: United States
facility: The Reading Neck & Spine Center
state: Pennsylvania
city: Johnson City
country: United States
facility: East Tennessee Brain & Spine
state: Tennessee
city: Fort Worth
country: United States
facility: Fort Worth Brain & Spine
state: Texas
city: Plano
country: United States
facility: Brain and Spine Center of Texas
state: Texas
city: Tyler
country: United States
facility: Azalea Orthopedic & Sports Medicine Clinic
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Charlottesville
country: United States
facility: UVA Dept. of Neurosurgery
state: Virginia
Study officials:
affiliation: The Hughston Clinic, P.C.
name: Kenneth Burkus, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Spine Institute
name: John Dimar, MD
role: PRINCIPAL_INVESTIGATOR
References: