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Degenerative Disc DiseasePhase 3CRMNCT00707265

rhBMP-2/CRM/CD HORIZON® Spinal System Pivotal Study

A Phase 3 study testing rhBMP-2/CRM/CD HORIZON® Spinal System and Autograft/CD HORIZON® Spinal System in people with Degenerative Disc Disease, run by Medtronic Spinal and Biologics at 28 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Degenerative Disc Disease
What is being tested?
rhBMP-2/CRM/CD HORIZON® Spinal System and Autograft/CD HORIZON® Spinal System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
463 participants
Where
28 sitesUnited States
Study dates
Mar 2002to Feb 2010
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Each patient participating in this clinical trial must meet all of the following inclusion criteria:
  • 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:
  • Requires fusion of a single level disc space from L1 to S1.
  • 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.
  • If of child-bearing potential, patient is non-pregnant, non-nursing, and agrees to use adequate contraception for 1 year following surgery.

Who cannot join

  • A patient meeting any of the following criteria is to be excluded from this clinical trial:
  • Has primary diagnosis of a spinal disorder other than degenerative disc disease with Grade 1 or less spondylolisthesis at the involved level.
  • Had previous spinal fusion surgical procedure at the involved level.
  • Requires spinal fusion at more than one lumbar level.
  • Has been previously diagnosed with osteopenia.
  • Has presence of active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin).
Show all 10Show fewer
  • Has a history of autoimmune disease (e.g. Systemic Lupus Erythematosus or dermatomyositis).
  • Has a history of exposure to injectable collagen or silicone implants.
  • 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.
  • Has received any previous exposure to any/all BMP's of either human or animal extraction.

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

United States28 sites

  • Alvin & Lois Lapidus Cancer Insitute

    Baltimore, Maryland, 21215

  • The Spine Institute

    Carmel, Indiana, 46032

  • UVA Dept. of Neurosurgery

    Charlottesville, Virginia, 22908

  • The Hughston Clinic P.C.

    Columbus, Georgia, 31908

  • Duke University Hospital

    Durham, North Carolina, 27710

  • Fort Worth Brain & Spine

    Fort Worth, Texas, 76104

  • Barrington Orthopedic Specialists

    Hoffman Estates, Illinois, 60195

  • University of Iowa Hospitals & Clinics

    Iowa City, Iowa, 52241

  • East Tennessee Brain & Spine

    Johnson City, Tennessee, 37604

  • Spine Institute

    Louisville, Kentucky, 40202

  • Medford Neurological & Spine Clinic

    Medford, Oregon, 97504

  • Brevard Orthopaedic Clinic, Inc.

    Melbourne, Florida, 32901

  • Orthopedic Spine Care of Long Island, PC

    Melville, New York, 11747

  • Beth Israel Medical Center

    New York, New York, 10003

  • Orthopaedic Specialty Institute

    Orange, California, 92868

  • Lutheran Spine Center

    Park Ridge, Illinois, 60068

  • Barrow Neurosurgical Associates

    Phoenix, Arizona, 85013

  • Brain and Spine Center of Texas

    Plano, Texas, 75093

  • University of Utah

    Salt Lake City, Utah, 84132

  • UCLA Orthopedic Hospital

    Santa Monica, California, 90404

  • Jeffrey S. Fischgrund

    Southfield, Michigan, 48034

  • Florida Ortho Institute

    Tampa, Florida, 33637

  • Central States Orthopedic Specialists

    Tulsa, Oklahoma, 74136

  • Azalea Orthopedic & Sports Medicine Clinic

    Tyler, Texas, 75701

  • Georgetown University Dept. of Orthopaedic Spine Surgery

    Washington D.C., District of Columbia, 20007

  • Des Moines Orthopaedic Surgeons

    West Des Moines, Iowa, 50266

  • Florida Neurological Consultants

    Winter Park, Florida, 32789

  • The Reading Neck & Spine Center

    Wyomissing, Pennsylvania, 19610

Other trials in United States

About this 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

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.

Read the 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.

Being tested
rhBMP-2/CRM/CD HORIZON® Spinal System, Autograft/CD HORIZON® Spinal System
Medical subject headings
Intervertebral Disc Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rhBMP-2/CRM/CD HORIZON® Spinal SystemDevice

    Also called rhBMP-2, CRM, CD HORIZON® Spinal System

    The rhBMP-2/CRM component of the investigational device consists of recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) and a compression resistant matrix (CRM) carrier consisting of an absorbable collagen sponge imbedded with biphasic calcium phosphate.

    The posterior spinal fixation system, the CD HORIZON® Spinal System, is a commercially available rod-based spinal system intended for temporary stabilization of the spine in order to facilitate fusion. The CD HORIZON® Spinal System is available in either titanium or stainless steel. For this study, only titanium implant components will be used.

  • Autograft/CD HORIZON® Spinal SystemDevice

    Also called Autograft, CD HORIZON® Spinal System

    The control will be autogenous bone taken from the iliac crest of the patient and placed bilaterally across two adjacent transverse processes and used in conjunction with the CD HORIZON® Spinal System. When used as a posterior spine thoracic/lumbar system, the CD HORIZON® CANNULATED M8 MULTI-AXIAL SCREW components are intended for several indications including degenerative disc disease.

Study groups in NCT00707265
Study groupRoleWhat they receive
InvestigationalExperimentalOpen bilateral posterolateral implantation of the rhBMP-2/CRM/CD HORIZON® Spinal System.
Receives: Device: rhBMP-2/CRM/CD HORIZON® Spinal System
ControlActive comparatorThe bilateral posterolateral implantation of the autogenous bone harvested from the iliac crest with the CD HORIZON® Spinal System.
Receives: Device: Autograft/CD HORIZON® Spinal System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Success

    A patient will be considered an overall success if all of the following conditions are met:

    1. fusion;
    2. pain/disability (Oswestry) improvement;
    3. maintenance or improvement in neurological status;
    4. no serious adverse event classified as implant associated or implant/surgical procedure associated;
    5. no additional surgical procedure classified as a "failure."

    Measured: 24 months

Secondary outcomes (9)

  1. Fusion

    Fusion is defined as:

    1. Evidence of bridging trabecular bone.
    2. No evidence of motion.
    3. Absence of cracking, as evidenced by radiolucent lines completely through the fusion mass.

    Measured: 24 months

  2. Pain/Disability Status

    The self-administered Oswestry Low Back Pain Disability Questionnaire will be used. Success will be defined as pain/disability improvement postoperatively according to the definition: Preoperative Score - Postoperative Score >= 15 points

    Measured: 24 months

  3. Overall Neurological Status

    Neurological status will be assessed preoperatively and postoperatively using a neurological status scale. Neurological status is based on four types of measurements (sections): motor, sensory, reflexes, and straight leg raise. Overall measure of neurological status will be based on success statuses in the four parameters.

    Measured: 24 months

  4. General Health Status

    The Medical Outcomes Study 36-item Short Form Health Survey (SF-36) will be used to assess general health status. The SF-36 results can be summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). Success will be defined as a maintenance or improvement in status postoperatively as compared to the preoperative condition. To be classified as a success, the following criteria must be met:

    PCSPostop - PCSPreop >= 0; MCSPostop - MCSPreop >= 0

    Measured: 24 months

  5. Back Pain

    Numerical rating scales will be used to evaluate pain intensity and duration. The pain score (0 min, 20 Max) is derived by adding the numerical rating scores from the pain intensity (0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be.") and duration scales (0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time"). Success for back and leg pain is described as follows:

    Preoperative Score - Postoperative Score >=0

    Measured: 24 months

  6. Leg Pain

    Numerical rating scales will be used to evaluate pain intensity and duration. The pain score (0 min, 20 Max) is derived by adding the numerical rating scores from the pain intensity (0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be.") and duration scales (0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time"). Success for back and leg pain is described as follows:

    Preoperative Score - Postoperative Score >=0

    Measured: 24 months

  7. Operative Time

    Measured: At the time of operation

  8. Blood Loss

    Measured: At the time of operation

  9. Hospital Days

    Measured: At the time of discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2008 (estimated)
  2. Study startMar 2002
  3. Primary completionMay 2005
  4. Study completionFeb 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
463 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00707265
Sponsor's protocol ID
P01-05
Acronym
CRM
Status last verified
May 2023
First submitted
26 Jun 2008
Last updated
10 May 2023
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing rhBMP-2/CRM/CD HORIZON® Spinal System and Autograft/CD HORIZON® Spinal System in people with Degenerative Disc Disease, run by Medtronic Spinal and Biologics at 28 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Success (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00707265.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.

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rhBMP-2/CRM/CD HORIZON® Spinal System Pivotal Study | AzTrials