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

Degenerative Disc Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00707265
• Other study ID #: P01-05
• Status: Completed
• Phase: Phase 3
• Start date: March 2002
• Est. completion date: February 2010

Study information

• Verified date: May 2023
• Source: Medtronic Spinal and Biologics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 463
• Est. completion date: February 2010
• Est. primary completion date: May 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration

Intervention

Device:
• 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 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.

Locations

Country	Name	City	State
United States	Alvin & Lois Lapidus Cancer Insitute	Baltimore	Maryland
United States	The Spine Institute	Carmel	Indiana
United States	UVA Dept. of Neurosurgery	Charlottesville	Virginia
United States	The Hughston Clinic P.C.	Columbus	Georgia
United States	Duke University Hospital	Durham	North Carolina
United States	Fort Worth Brain & Spine	Fort Worth	Texas
United States	Barrington Orthopedic Specialists	Hoffman Estates	Illinois
United States	University of Iowa Hospitals & Clinics	Iowa City	Iowa
United States	East Tennessee Brain & Spine	Johnson City	Tennessee
United States	Spine Institute	Louisville	Kentucky
United States	Medford Neurological & Spine Clinic	Medford	Oregon
United States	Brevard Orthopaedic Clinic, Inc.	Melbourne	Florida
United States	Orthopedic Spine Care of Long Island, PC	Melville	New York
United States	Beth Israel Medical Center	New York	New York
United States	Orthopaedic Specialty Institute	Orange	California
United States	Lutheran Spine Center	Park Ridge	Illinois
United States	Barrow Neurosurgical Associates	Phoenix	Arizona
United States	Brain and Spine Center of Texas	Plano	Texas
United States	University of Utah	Salt Lake City	Utah
United States	UCLA Orthopedic Hospital	Santa Monica	California
United States	Jeffrey S. Fischgrund	Southfield	Michigan
United States	Florida Ortho Institute	Tampa	Florida
United States	Central States Orthopedic Specialists	Tulsa	Oklahoma
United States	Azalea Orthopedic & Sports Medicine Clinic	Tyler	Texas
United States	Georgetown University Dept. of Orthopaedic Spine Surgery	Washington	District of Columbia
United States	Des Moines Orthopaedic Surgeons	West Des Moines	Iowa
United States	Florida Neurological Consultants	Winter Park	Florida
United States	The Reading Neck & Spine Center	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Spinal and Biologics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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."	24 months
Secondary	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.	24 months
Secondary	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	24 months
Secondary	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.	24 months
Secondary	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	24 months
Secondary	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	24 months
Secondary	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	24 months
Secondary	Operative Time		At the time of operation
Secondary	Blood Loss		At the time of operation
Secondary	Hospital Days		At the time of discharge