Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis
Conditions
Brief summary
Spine fusion is one of the most common procedures performed in spinal surgery. Several surgical techniques can achieve a solid union, but the intertransverse posterolateral fusion (PLF) is the most widely used. However, complications can develop when the bone graft material used is insufficient to achieve the desired fusion. With its unique properties, nanOss Bioactive 3D can be mixed with bone marrow aspirate (BMA) and autograft bone to obtain new bone growth during the healing process. nanOss Bioactive 3D is approved for use in the U.S., however, additional information is useful to assess its efficacy in the posterolateral spine. The purpose of this study is to assess fusion results in the posterolateral spine using nanOss Bioactive 3D mixed with autograft bone and BMA. It is hypothesized that the use of nanOss Bioactive 3D will result in fusion at 12 months, with CT evidence of bridging trabecular bone, less than 3mm of translational motion, and less than 5 degrees of angular motion.
Detailed description
The post market clinical investigation is designed to assess instrumented PLF using nanOss Bioactive 3D bone void filler with autograft bone and bone marrow aspirate in patients with symptomatic spinal stenosis secondary to degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at one or two adjacent levels from L2-S1 characterized by the inclusion and exclusion criteria. Patients will be evaluated at Preop, discharge, 6 and 12 months. X-rays will be obtained at each visit; Additionally, a CT scan will be performed at the 12 month postoperative visit to assess fusion status.
Interventions
DEVICEnanOss Bioactive 3D BVF
nanOss Bioactive 3D BVF, combined with autograft and bone marrow aspirate, used in the posterolateral spine between L2 and S1. Instrumentation is required. Interbody fusion with PEEK device and autograft may or may not be performed.
Sponsors
Pioneer Surgical Technology, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 21 years of age and skeletally mature. * Symptomatic spinal stenosis secondary to DDD with up to Grade 1 spondylolisthesis at one or two adjacent levels from L2-S1 requiring instrumented PLF surgery. * Completed a minimum of 6 months of non-operative treatment. * Pre-operative objective evidence of primary diagnosis confirmed by appropriate imaging studies (AP, Lateral, Flexion and Extension images and an MRI or CT scan). * Is willing and able to return for post-treatment exams according to the follow-up called for in the protocol. * Is able to review, understand and sign the informed consent document.
Exclusion criteria
* Symptomatic at more than two levels. * Has had previous fusion surgery at the level(s) to be treated (previous discectomy, laminotomy, laminectomy or nucleolysis at the level(s) to be treated \< 6 months ago is ok). * Has \> 11 degrees lumbar scoliosis. * Has \> 40 BMI. * Has \> Grade 1 spondylolisthesis. * Has osteoporosis (T-score of -2.5 or below), osteomalacia, Paget's disease or metabolic bone disease. * Has a disease that significantly inhibits bone healing (e.g., diabetes type 1, renal failure, impaired calcium metabolism). * Has a medical condition that requires or has a history of chronic steroid use (i.e., oral steroids), with the exception of inhaled/nasal corticosteroids steroids or has any medical condition that requires treatment with drugs known to interfere with bone healing. * Has a neurological disease (e.g., Parkinson's disease), a psychosocial disorder (e.g., suicidal, diminished capacity) or has a history of substance abuse which would preclude accurate evaluation or limit the ability to comply with study requirements. * Has either an active infection or infection at the site of surgery * Has a systemic disease (e.g., AIDS, HIV, active hepatitis, tuberculosis) * Has rheumatoid arthritis or other autoimmune disease. * Has spinal tumors. * Has an active malignancy (except non-melanoma skin cancer) or history of any invasive malignancy unless treated and in remission for at least five years. * Has a known sensitivity or allergies to porcine collagen, PEEK, tantalum or titanium. * Has active arachnoiditis. * Has fractures of the epiphyseal plate or fractures for which stabilization of the fracture is not possible. * Is a prisoner. * Is involved in spinal litigation at the treated level(s). * Is participating in another clinical study that would confound Study data. * Is pregnant or is interested in becoming pregnant while participating in the Study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Fusion | 12 months | Fusion is defined as the presence of bridging trabecular bone and less than 3mm of translational motion and less than 5mm of angular motion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Improvement in Quality of Life | 12 months | Number of participants with improvement in quality of life after surgery using the RAND-36 (a short form health survey). It is a 36 set of easily administered quality of life measures answered by the patient. |
| Number of Participants With Improvement in Pain Scores | 12 months | Number of participants with improvement in pain scores after surgery using the Visual Analog Scale. The scale measured from (0) no pain to (10) unbearable pain. |
| Number of Participants With Decreased Usage of Pain Medication | 12 months | Number of participants with decreased usage of pain medication after surgery |
| Returning to Work | 12 Months | Time frame in which patient returned to work after surgery |
| Satisfaction With Surgery | 12 months | Overall satisfaction with the procedure |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| nanOss Bioactive 3D BVF Bilateral, instrumented posterolateral fusion surgery where nanOss Bioactive 3D will be hydrated with autologous BMA and placed bilaterally on a bed of local autograft bone spanning the transverse processes of the treated segment. If an interbody fusion is performed, only a PLIF or TLIF with PEEK IBF devices may be performed.
nanOss Bioactive 3D BVF: nanOss Bioactive 3D BVF, combined with autograft and bone marrow aspirate, used in the posterolateral spine between L2 and S1. Instrumentation is required. Interbody fusion with PEEK device and autograft may or may not be performed. | 22 |
| Total | 22 |
Baseline characteristics
| Characteristic | nanOss Bioactive 3D BVF |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants |
| Age, Continuous | 60 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Region of Enrollment United States | 22 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 22 |
| other Total, other adverse events | 19 / 22 |
| serious Total, serious adverse events | 3 / 22 |
Outcome results
Primary
Number of Patients With Fusion
Fusion is defined as the presence of bridging trabecular bone and less than 3mm of translational motion and less than 5mm of angular motion.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| nanOss Bioactive 3D BVF | Number of Patients With Fusion | 16 Participants |
Secondary
Number of Participants With Decreased Usage of Pain Medication
Number of participants with decreased usage of pain medication after surgery
Time frame: 12 months
Population: Data was not collected
Secondary
Number of Participants With Improvement in Pain Scores
Number of participants with improvement in pain scores after surgery using the Visual Analog Scale. The scale measured from (0) no pain to (10) unbearable pain.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| nanOss Bioactive 3D BVF | Number of Participants With Improvement in Pain Scores | 18 Participants |
Secondary
Number of Participants With Improvement in Quality of Life
Number of participants with improvement in quality of life after surgery using the RAND-36 (a short form health survey). It is a 36 set of easily administered quality of life measures answered by the patient.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| nanOss Bioactive 3D BVF | Number of Participants With Improvement in Quality of Life | 16 Participants |
Secondary
Returning to Work
Time frame in which patient returned to work after surgery
Time frame: 12 Months
Population: Data was not collected
Secondary
Satisfaction With Surgery
Overall satisfaction with the procedure
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| nanOss Bioactive 3D BVF | Satisfaction With Surgery | 18 Participants |