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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Degenerative Disc Disease

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Trial Information

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


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 autogeneous 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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall Success

Outcome Description:

A patient will be considered an overall success if all of the following conditions are met: fusion; pain/disability (Oswestry) improvement; maintenance or improvement in neurological status; no serious adverse event classified as implant associated or implant/surgical procedure associated; no additional surgical procedure classified as a "failure."

Outcome Time Frame:

24 months

Safety Issue:

Yes

Principal Investigator

Kenneth Burkus, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Hughston Clinic, P.C.

Authority:

United States: Food and Drug Administration

Study ID:

P01-05

NCT ID:

NCT00707265

Start Date:

March 2002

Completion Date:

February 2010

Related Keywords:

  • Degenerative Disc Disease
  • Spinal Diseases
  • Intervertebral Disk Degeneration

Name

Location

Beth Israel Medical CenterNew York, New York  10003
University of UtahSalt Lake City, Utah  
Duke University HospitalDurham, North Carolina  27710
University of Iowa Hospitals & ClinicsIowa City, Iowa  52242
Barrow Neurosurgical AssociatesPhoenix, Arizona  85013
Orthopaedic Specialty InstituteOrange, California  92868
UCLA Orthopedic HospitalSanta Monica, California  90404
Georgetown University Dept. of Orthopaedic Spine SurgeryWashington, District of Columbia  20007
Brevard Orthopaedic Clinic, Inc.Melbourne, Florida  32901
Florida Ortho InstituteTampa, Florida  33637
Florida Neurological ConsultantsWinter Park, Florida  32789
The Hughston Clinic P.C.Columbus, Georgia  31908
Barrington Orthopedic SpecialistsHoffman Estates, Illinois  60195
Lutheran Spine CenterPark Ridge, Illinois  60068
The Spine InstituteCarmel, Indiana  46032
Des Moines Orthopaedic SurgeonsWest Des Moines, Iowa  50266
Spine InstituteLouisville, Kentucky  40202
Alvin & Lois Lapidus Cancer InsituteBaltimore, Maryland  21215
Jeffrey S. FischgrundSouthfield, Michigan  48034
Orthopedic Spine Care of Long Island, PCMelville, New York  11747
Central States Orthopedic SpecialistsTulsa, Oklahoma  74136
Medford Neurological & Spine ClinicMedford, Oregon  97504
The Reading Neck & Spine CenterWyomissing, Pennsylvania  19610
East Tennessee Brain & SpineJohnson City, Tennessee  37604
Fort Worth Brain & SpineFort Worth, Texas  76104
Brain and Spine Center of TexasPlano, Texas  75093
Azalea Orthopedic & Sports Medicine ClinicTyler, Texas  75701
UVA Dept. of NeurosurgeryCharlottesville, Virginia  22908