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CompletedNCT01829997Updated Apr 17, 2019Results posted

Assessment of nanOss Bioactive 3D in the Posterolateral Spine

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

Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Not applicable
Ages
21 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Degenerative Disc Disease
  • Spinal Stenosis
  • Spondylolisthesis
03

In context

Intervertebral Disc Degeneration

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 →

Lead sponsor

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.

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Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    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.

    Device: nanOss Bioactive 3D BVF

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.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. Number of Participants With Decreased Usage of Pain Medication

    Number of participants with decreased usage of pain medication after surgery

    Time frame: 12 months

  4. Returning to Work

    Time frame in which patient returned to work after surgery

    Time frame: 12 Months

  5. Satisfaction With Surgery

    Overall satisfaction with the procedure

    Time frame: 12 months

07

Results

Posted Apr 17, 2019

Participant flow

Participant flow — Overall Study
MilestonenanOss Bioactive 3D BVF
Started22
Completed16
Not completed6

Outcome measures

PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Patients With Fusion
ParticipantsnanOss Bioactive 3D BVF
Number of Patients With Fusion16
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With Improvement in Quality of Life
ParticipantsnanOss Bioactive 3D BVF
Number of Participants With Improvement in Quality of Life16
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With Improvement in Pain Scores
ParticipantsnanOss Bioactive 3D BVF
Number of Participants With Improvement in Pain Scores18
SecondaryNumber of Participants With Decreased Usage of Pain Medication

Number of participants with decreased usage of pain medication after surgery

Time frame:
12 months

No measurements were reported for this outcome.

SecondaryReturning to Work

Time frame in which patient returned to work after surgery

Time frame:
12 Months

No measurements were reported for this outcome.

SecondarySatisfaction With Surgery

Overall satisfaction with the procedure

Time frame:
12 months
Reported as:
Count of participants · Participants
Satisfaction With Surgery
ParticipantsnanOss Bioactive 3D BVF
Satisfaction With Surgery18

Adverse events

Collected over 2 years. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
nanOss Bioactive 3D BVF0/22 (0%)3/22 (13.6%)19/22 (86.4%)
Most frequent serious events
Most frequent serious events
EventnanOss Bioactive 3D BVF
Continued leg painMusculoskeletal and connective tissue disorders1/22
Increased bilateral leg painMusculoskeletal and connective tissue disorders1/22
Right iliac implant painMusculoskeletal and connective tissue disorders1/22
Most frequent other events
Most frequent other events
EventnanOss Bioactive 3D BVF
Right leg painMusculoskeletal and connective tissue disorders7/22
Bilateral leg painMusculoskeletal and connective tissue disorders2/22
Lower back painMusculoskeletal and connective tissue disorders2/22
Arm tinglingMusculoskeletal and connective tissue disorders2/22
Continued leg painMusculoskeletal and connective tissue disorders1/22
HerniaMusculoskeletal and connective tissue disorders1/22
Neck painMusculoskeletal and connective tissue disorders1/22
Bleeding hemorrhoidsGeneral disorders1/22
Altered mental statusGeneral disorders1/22
CSF LeakGeneral disorders1/22

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)nanOss Bioactive 3D BVF
<=18 years0
Between 18 and 65 years19
>=65 years3
Age, Continuous
Age, Continuous(years)nanOss Bioactive 3D BVF
Mean60 (37 to 76)
Sex: Female, Male
Sex: Female, Male(Participants)nanOss Bioactive 3D BVF
Female14
Male8
Race (NIH/OMB)
Race (NIH/OMB)(Participants)nanOss Bioactive 3D BVF
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American3
White19
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)nanOss Bioactive 3D BVF
United States22
08

Study locations

4 sites
  • Hospital for Joint Disease
    New York, New York 10003, United States
  • Hospital for Special Surgery
    New York, New York 10021, United States
  • MUSC Neurosurgery & Spine Services
    Charleston, South Carolina 29425, United States
  • Milwaukee Spinal Specialists
    Glendale, Wisconsin 53212, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Jun 10, 2013

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01829997
Lead sponsor
Pioneer Surgical Technology, Inc.
Responsible party
Sponsor
First posted
Apr 11, 2013
Start date
Apr 2013
Primary completion
Apr 2018
Completion
Apr 2018
Results posted
Apr 17, 2019
Last update
Apr 17, 2019

Study contacts

Stephen Robbins, MD
principal investigator · Milwaukee Spinal Specialists

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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