INFUSE®Bone Graft in Transforaminal Lumbar Interbody Fusion for Degenerative Disease of Lumbosacral Spine (TLIF)
This investigation will provide safety and effectiveness information on the use of INFUSE® Bone Graft with the CAPSTONE® Spinal System and CD HORIZON® Spinal System with a Transforaminal Lumbar Interbody Fusion (TLIF) surgical approach at one or two adjacent levels from L2-S1 to treat subjects with advanced degenerative disease of the lumbosacral spine. These data will be used to seek regulatory approval for the use of INFUSE® Bone Graft for this indication.
Lumbar Spine Degeneration
Device: INFUSE Bone Graft
Other: Iliac Crest Bone Graft
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective, Multi-center, Pivotal Trial for INFUSE® Bone Graft With CAPSTONE® Spinal System and Posterior Supplemental Fixation to Treat 1- or 2-level Advanced Degenerative Disease of the Lumbosacral Spine For a TLIF Approach|
- Overall Success [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
A subject will be considered an overall success if all of the following conditions are met:
- fusion at all treated levels (e.g., one level for a one level fusion and two levels for a two level fusion);
- pain/disability (Oswestry Disability Index) success;
- neurological status success;
- no serious adverse event classified as "implant associated" or "implant/surgical procedure" associated per the ISO definition of "serious;"
- no additional surgical procedure classified as a "failure."
- Radiographic Fusion [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Fusion success is defined radiographically as:
- Evidence of bridging bone.
- No evidence of motion.
- No evidence of radiolucency at greater than 50% of the superior or inferior PEEK spacer-vertebra interface.
- Pain/Disability Status [ Time Frame: 24 months ] [ Designated as safety issue: No ]
The self-administered Oswestry Disability Index will be used. Success will be defined as pain/disability improvement postoperatively according to the following definition:
Preoperative Score - Postoperative Score >= 15 points
- Neurological Status [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]Neurological status is based on six types of measurements: motor, sensory, reflexes, straight leg raising, bowel function, and bladder function. Each of the sections is comprised of a number of elements.Overall neurological success will be defined as maintenance or improvement in the three key neurological assessments—motor and sensory examinations and deep tendon reflexes.
- Pain Status (Back Pain and Leg Pain) [ Time Frame: 24 months ] [ Designated as safety issue: No ]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
- General Health Status [ Time Frame: 24 months ] [ Designated as safety issue: No ]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). To be classified as a success, the following criteria must be met for SF-36 PCS and MCS, respectively: PCSPostop - PCSPreop >= 0; MCSPostop - MCSPreop >= 0
- Additional Surgical Procedures/Interventions [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- Surgery and Hospitalization Information [ Time Frame: At the time of discharge ] [ Designated as safety issue: No ]Surgery and hospitalization information includes operative time, blood loss, and number of hospital days.
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||July 2017|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
|Active Comparator: Control Group||
Other: Iliac Crest Bone Graft
Subjects enrolled in the control group will receive the same surgical treatment as the investigational group, including the CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System), except for the use of autogenous bone graft (from the iliac crest) instead of INFUSE® Bone Graft. A TLIF surgical approach will also be used for implanting the control treatment.
Other Name: Autograft
|Experimental: Investigational Group||
Device: INFUSE Bone Graft
Subjects enrolled in the investigational treatment group will receive surgical treatment with INFUSE® Bone Graft, the CAPSTONE® Spinal System, and posterior supplemental fixation (in this study the CD HORIZON® Spinal System). The investigational treatment will be implanted using a TLIF surgical approach.
Other Name: rhBMP-2/ACS
The study is a prospective, multi-national study that compares INFUSE® Bone Graft (investigational group) to autogenous bone graft (control group). Control group subjects will receive the same surgical treatment except for the use of autogenous bone graft (from the iliac crest) instead of INFUSE® Bone Graft. All sites will follow a common Clinical Investigational Plan (CIP) that consists of the protocol and accompanying case report forms, risk analysis, investigator's agreement, subject informed consent, institutional review board (IRB) certification, labeling, and monitoring information.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01415908
|United States, Arizona|
|Sonoran Spine Center|
|Mesa, Arizona, United States, 85202|
|United States, California|
|USC Department of Neurological Surgery|
|Los Angeles, California, United States, 90033|
|United States, Florida|
|Gulf Breeze, Florida, United States, 32561|
|United States, Indiana|
|Fort Wayne Orthopaedics|
|Fort Wayne, Indiana, United States, 46804|
|United States, Pennsylvania|
|Pittsburgh, Pennsylvania, United States, 15213|