rhBMP-2/CRM/CD HORIZON® Spinal System Pivotal Study
- Conditions
- Degenerative Disc Disease
- Registration Number
- NCT00707265
- Lead Sponsor
- Medtronic Spinal and Biologics
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 463
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Overall Success 24 months 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."
- Secondary Outcome Measures
Name Time Method Fusion 24 months 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.Overall Neurological Status 24 months 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.
Pain/Disability Status 24 months 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
General Health Status 24 months 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 \>= 0Leg Pain 24 months 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 \>=0Hospital Days At the time of discharge Back Pain 24 months 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 \>=0Blood Loss At the time of operation Operative Time At the time of operation
Trial Locations
- Locations (28)
Barrow Neurosurgical Associates
🇺🇸Phoenix, Arizona, United States
Orthopaedic Specialty Institute
🇺🇸Orange, California, United States
UCLA Orthopedic Hospital
🇺🇸Santa Monica, California, United States
Georgetown University Dept. of Orthopaedic Spine Surgery
🇺🇸Washington, District of Columbia, United States
Brevard Orthopaedic Clinic, Inc.
🇺🇸Melbourne, Florida, United States
Florida Ortho Institute
🇺🇸Tampa, Florida, United States
Florida Neurological Consultants
🇺🇸Winter Park, Florida, United States
The Hughston Clinic P.C.
🇺🇸Columbus, Georgia, United States
Barrington Orthopedic Specialists
🇺🇸Hoffman Estates, Illinois, United States
Lutheran Spine Center
🇺🇸Park Ridge, Illinois, United States
Scroll for more (18 remaining)Barrow Neurosurgical Associates🇺🇸Phoenix, Arizona, United States