Back to resultsrhBMP-2/CRM/CD HORIZON® Spinal System Pivotal Study (CRM)
Primary Purpose
Degenerative Disc Disease
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
rhBMP-2/CRM/CD HORIZON® Spinal System
Autograft/CD HORIZON® Spinal System
Sponsored by
About this trial
This is an interventional treatment trial for Degenerative Disc Disease
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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).
- 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.
Sites / Locations
- Barrow Neurosurgical Associates
- Orthopaedic Specialty Institute
- UCLA Orthopedic Hospital
- Georgetown University Dept. of Orthopaedic Spine Surgery
- Brevard Orthopaedic Clinic, Inc.
- Florida Ortho Institute
- Florida Neurological Consultants
- The Hughston Clinic P.C.
- Barrington Orthopedic Specialists
- Lutheran Spine Center
- The Spine Institute
- University of Iowa Hospitals & Clinics
- Des Moines Orthopaedic Surgeons
- Spine Institute
- Alvin & Lois Lapidus Cancer Insitute
- Jeffrey S. Fischgrund
- Orthopedic Spine Care of Long Island, PC
- Beth Israel Medical Center
- Duke University Hospital
- Central States Orthopedic Specialists
- Medford Neurological & Spine Clinic
- The Reading Neck & Spine Center
- East Tennessee Brain & Spine
- Fort Worth Brain & Spine
- Brain and Spine Center of Texas
- Azalea Orthopedic & Sports Medicine Clinic
- University of Utah
- UVA Dept. of Neurosurgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Investigational
Control
Arm Description
Open bilateral posterolateral implantation of the rhBMP-2/CRM/CD HORIZON® Spinal System.
The bilateral posterolateral implantation of the autogenous bone harvested from the iliac crest with the CD HORIZON® Spinal System.
Outcomes
Primary Outcome Measures
Overall Success
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."
Secondary Outcome Measures
Fusion
Fusion is defined as:
Evidence of bridging trabecular bone.
No evidence of motion.
Absence of cracking, as evidenced by radiolucent lines completely through the fusion mass.
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
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.
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
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
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
Operative Time
Blood Loss
Hospital Days
Full Information
NCT ID
NCT00707265
First Posted
June 26, 2008
Last Updated
May 9, 2023
Sponsor
Medtronic Spinal and Biologics
1. Study Identification
Unique Protocol Identification Number
NCT00707265
Brief Title
rhBMP-2/CRM/CD HORIZON® Spinal System Pivotal Study
Acronym
CRM
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
May 2005 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Spinal and Biologics
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Disc Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
463 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Investigational
Arm Type
Experimental
Arm Description
Open bilateral posterolateral implantation of the rhBMP-2/CRM/CD HORIZON® Spinal System.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
The bilateral posterolateral implantation of the autogenous bone harvested from the iliac crest with the CD HORIZON® Spinal System.
Intervention Type
Device
Intervention Name(s)
rhBMP-2/CRM/CD HORIZON® Spinal System
Other Intervention Name(s)
rhBMP-2, CRM, CD HORIZON® Spinal System
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Autograft/CD HORIZON® Spinal System
Other Intervention Name(s)
Autograft, CD HORIZON® Spinal System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall Success
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."
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Fusion
Description
Fusion is defined as:
Evidence of bridging trabecular bone.
No evidence of motion.
Absence of cracking, as evidenced by radiolucent lines completely through the fusion mass.
Time Frame
24 months
Title
Pain/Disability Status
Description
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
Time Frame
24 months
Title
Overall Neurological Status
Description
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.
Time Frame
24 months
Title
General Health Status
Description
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
Time Frame
24 months
Title
Back Pain
Description
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
Time Frame
24 months
Title
Leg Pain
Description
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
Time Frame
24 months
Title
Operative Time
Time Frame
At the time of operation
Title
Blood Loss
Time Frame
At the time of operation
Title
Hospital Days
Time Frame
At the time of discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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).
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Burkus, MD
Organizational Affiliation
The Hughston Clinic, P.C.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Dimar, MD
Organizational Affiliation
Spine Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barrow Neurosurgical Associates
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Orthopaedic Specialty Institute
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
UCLA Orthopedic Hospital
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Georgetown University Dept. of Orthopaedic Spine Surgery
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Brevard Orthopaedic Clinic, Inc.
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Florida Ortho Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33637
Country
United States
Facility Name
Florida Neurological Consultants
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
The Hughston Clinic P.C.
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31908
Country
United States
Facility Name
Barrington Orthopedic Specialists
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60195
Country
United States
Facility Name
Lutheran Spine Center
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
The Spine Institute
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
University of Iowa Hospitals & Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52241
Country
United States
Facility Name
Des Moines Orthopaedic Surgeons
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Spine Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Alvin & Lois Lapidus Cancer Insitute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Jeffrey S. Fischgrund
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48034
Country
United States
Facility Name
Orthopedic Spine Care of Long Island, PC
City
Melville
State/Province
New York
ZIP/Postal Code
11747
Country
United States
Facility Name
Beth Israel Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Central States Orthopedic Specialists
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Medford Neurological & Spine Clinic
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
The Reading Neck & Spine Center
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
East Tennessee Brain & Spine
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37604
Country
United States
Facility Name
Fort Worth Brain & Spine
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Brain and Spine Center of Texas
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Azalea Orthopedic & Sports Medicine Clinic
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
UVA Dept. of Neurosurgery
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
12. IPD Sharing Statement
Learn more about this trial
rhBMP-2/CRM/CD HORIZON® Spinal System Pivotal Study
We'll reach out to this number within 24 hrs