An interventional study of nanOss Bioactive 3D BVF in Degenerative Disc Disease, Spinal Stenosis and Spondylolisthesis, sponsored by Pioneer Surgical Technology, Inc.. Completed at 4 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2019-04-17.
Sponsored by Pioneer Surgical Technology, Inc. · Not applicable, Interventional, and Treatment
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.
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.
472 studies on the registry are indexed under Intervertebral Disc Degeneration; 100 are open to participants now.
This study's enrollment of 22 is below the median of 60 across 268 interventional studies indexed under Intervertebral Disc Degeneration.
Browse Intervertebral Disc Degeneration studies →Pioneer Surgical Technology, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Device: 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.
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
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
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
Number of Participants With Decreased Usage of Pain Medication
Number of participants with decreased usage of pain medication after surgery
Time frame: 12 months
Returning to Work
Time frame in which patient returned to work after surgery
Time frame: 12 Months
Satisfaction With Surgery
Overall satisfaction with the procedure
Time frame: 12 months
| Milestone | nanOss Bioactive 3D BVF |
|---|---|
| Started | 22 |
| Completed | 16 |
| Not completed | 6 |
Fusion is defined as the presence of bridging trabecular bone and less than 3mm of translational motion and less than 5mm of angular motion.
| Participants | nanOss Bioactive 3D BVF |
|---|---|
| Number of Patients With Fusion | 16 |
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.
| Participants | nanOss Bioactive 3D BVF |
|---|---|
| Number of Participants With Improvement in Quality of Life | 16 |
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.
| Participants | nanOss Bioactive 3D BVF |
|---|---|
| Number of Participants With Improvement in Pain Scores | 18 |
Number of participants with decreased usage of pain medication after surgery
No measurements were reported for this outcome.
Time frame in which patient returned to work after surgery
No measurements were reported for this outcome.
Overall satisfaction with the procedure
| Participants | nanOss Bioactive 3D BVF |
|---|---|
| Satisfaction With Surgery | 18 |
Collected over 2 years. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| nanOss Bioactive 3D BVF | 0/22 (0%) | 3/22 (13.6%) | 19/22 (86.4%) |
| Event | nanOss Bioactive 3D BVF |
|---|---|
| Continued leg painMusculoskeletal and connective tissue disorders | 1/22 |
| Increased bilateral leg painMusculoskeletal and connective tissue disorders | 1/22 |
| Right iliac implant painMusculoskeletal and connective tissue disorders | 1/22 |
| Event | nanOss Bioactive 3D BVF |
|---|---|
| Right leg painMusculoskeletal and connective tissue disorders | 7/22 |
| Bilateral leg painMusculoskeletal and connective tissue disorders | 2/22 |
| Lower back painMusculoskeletal and connective tissue disorders | 2/22 |
| Arm tinglingMusculoskeletal and connective tissue disorders | 2/22 |
| Continued leg painMusculoskeletal and connective tissue disorders | 1/22 |
| HerniaMusculoskeletal and connective tissue disorders | 1/22 |
| Neck painMusculoskeletal and connective tissue disorders | 1/22 |
| Bleeding hemorrhoidsGeneral disorders | 1/22 |
| Altered mental statusGeneral disorders | 1/22 |
| CSF LeakGeneral disorders | 1/22 |
| Age, Categorical(Participants) | nanOss Bioactive 3D BVF |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 19 |
| >=65 years | 3 |
| Age, Continuous(years) | nanOss Bioactive 3D BVF |
|---|---|
| Mean | 60 (37 to 76) |
| Sex: Female, Male(Participants) | nanOss Bioactive 3D BVF |
|---|---|
| Female | 14 |
| Male | 8 |
| Race (NIH/OMB)(Participants) | nanOss Bioactive 3D BVF |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 19 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | nanOss Bioactive 3D BVF |
|---|---|
| United States | 22 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Intervertebral Disc Degeneration →
Pioneer Surgical Technology, Inc.