INFUSE®Bone Graft in Transforaminal Lumbar Interbody Fusion for Degenerative Disease of Lumbosacral Spine (TLIF)
|ClinicalTrials.gov Identifier: NCT01415908|
Recruitment Status : Terminated (Due to study design challenges including DMC enrollment suspension as required by the protocol stopping rules and recommended changes to the surgical technique)
First Posted : August 12, 2011
Results First Posted : October 28, 2015
Last Update Posted : February 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Lumbar Spine Degeneration||Device: INFUSE Bone Graft Other: Iliac Crest Bone Graft||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||January 2015|
|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.
- Rate of Overall Success [ Time Frame: 24 months ]
Rate of overall success is reported as percent of subjects who met all of the following criteria:
- 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";
- no additional surgical procedure classified as a "failure."
- Rate of Fusion Success [ Time Frame: 24 months ]
Rate of fusion success is reported as percent of subjects having fusion success. The fusion success was defined radiologically 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.
- Success Rate of Oswestry Disability Index [ Time Frame: 24 months ]ODI Questionnaire was used to assess patient back function. The ODI score ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability). Success rate of Oswestry Disability Index (ODI) is reported as percent of subjects whose ODI score met: pre-operative score - post-operative score ≥ 15.
- Success Rate of Neurological Status [ Time Frame: 24 months ]Neurological status was assessed in six sections: motor, sensory, reflexes, straight leg raising, bowel function, and bladder function. Each of the sections had a number of elements. Success rate of neurological status is reported as percent of subjects whose neurological status was maintained or improved in three key neurological assessments—motor, sensory, and deep tendon reflexes.
- Success Rate of Back Pain [ Time Frame: 24 months ]Numerical rating scales were used to evaluate back pain intensity and frequency. Subjects rated their back pain intensity on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be." Similarly, subjects recorded their back pain frequency on a scale from 0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time." The total back pain score were the sum of pain intensity and frequency scores. Success rate of back pain is reported as percent of subjects whose back pain improvement met: pre-operative score - post-operative score > 0.
- Success Rate of Leg Pain [ Time Frame: 24 months ]Numerical rating scales were used to evaluate leg pain intensity and frequency. Subjects rated their leg pain intensity on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be." Similarly, subjects recorded their leg pain frequency on a scale from 0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time." The total leg pain score were the sum of pain intensity and frequency scores. Success rate of leg pain is reported as percent of subjects whose leg pain improvement met: pre-operative score - post-operative score > 0.
- Success Rate of General Health Status [ Time Frame: 24 months ]The Medical Outcomes Study 36-Item Short Form (SF-36) health survey was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The scores for PCS and MCS are between 0 and 100, with higher scores denoting better quality of life. To be classified as a success, the following criteria must be met for SF-36 PCS and MCS, respectively: post-operative score - pre-operative score >= 0. The results are reported as percent of subjects who have SF-36 PCS success, SF-36 MCS success, and overall SF-36 success.
- Percent of Subjects Who Had Additional Surgical Procedures/Interventions [ Time Frame: 24 months ]
- Operative Time [ Time Frame: Operative time was recorded from skin incision to wound closure ]
- Blood Loss [ Time Frame: During the operation, an average of 200 minutes for investigational group and 281.5 minutes for control group ]
- Hospital Stay [ Time Frame: During the time of hospital stay ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|