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Assessment of nanOss Bioactive 3D in the Posterolateral Spine

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ClinicalTrials.gov Identifier: NCT01829997
Recruitment Status : Completed
First Posted : April 11, 2013
Results First Posted : April 17, 2019
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Pioneer Surgical Technology, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Degenerative Disc Disease
Spinal Stenosis
Spondylolisthesis
Intervention Device: nanOss Bioactive 3D BVF
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title nanOss Bioactive 3D BVF
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 22
Completed 16
Not Completed 6
Arm/Group Title nanOss Bioactive 3D BVF
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
<=18 years 0
Between 18 and 65 years 19
>=65 years 3
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 22 participants
60
(37 to 76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Female
14
  63.6%
Male
8
  36.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
  13.6%
White
19
  86.4%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants
22
1.Primary Outcome
Title Number of Patients With Fusion
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title nanOss Bioactive 3D BVF
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
16
  88.9%
2.Secondary Outcome
Title Number of Participants With Improvement in Quality of Life
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title nanOss Bioactive 3D BVF
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 16
Measure Type: Count of Participants
Unit of Measure: Participants
16
 100.0%
3.Secondary Outcome
Title Number of Participants With Improvement in Pain Scores
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title nanOss Bioactive 3D BVF
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
18
 100.0%
4.Secondary Outcome
Title Number of Participants With Decreased Usage of Pain Medication
Hide Description Number of participants with decreased usage of pain medication after surgery
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected
Arm/Group Title nanOss Bioactive 3D BVF
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Returning to Work
Hide Description Time frame in which patient returned to work after surgery
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected
Arm/Group Title nanOss Bioactive 3D BVF
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Satisfaction With Surgery
Hide Description Overall satisfaction with the procedure
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title nanOss Bioactive 3D BVF
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
18
 100.0%
Time Frame 2 years
Adverse Event Reporting Description 0
 
Arm/Group Title nanOss Bioactive 3D BVF
Hide Arm/Group Description

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.

All-Cause Mortality
nanOss Bioactive 3D BVF
Affected / at Risk (%)
Total   0/22 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
nanOss Bioactive 3D BVF
Affected / at Risk (%)
Total   3/22 (13.64%) 
Musculoskeletal and connective tissue disorders   
Continued leg pain   1/22 (4.55%) 
Increased bilateral leg pain   1/22 (4.55%) 
Right iliac implant pain   1/22 (4.55%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
nanOss Bioactive 3D BVF
Affected / at Risk (%)
Total   19/22 (86.36%) 
General disorders   
Bleeding hemorrhoids   1/22 (4.55%) 
Altered mental status   1/22 (4.55%) 
CSF Leak   1/22 (4.55%) 
Musculoskeletal and connective tissue disorders   
Right leg pain   7/22 (31.82%) 
Bilateral leg pain   2/22 (9.09%) 
Continued leg pain   1/22 (4.55%) 
Lower back pain   2/22 (9.09%) 
Hernia   1/22 (4.55%) 
Neck pain   1/22 (4.55%) 
Arm tingling   2/22 (9.09%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kristina Shine
Organization: RTI Surgical
Phone: 386-418-8888 ext 4404
EMail: kshine@rtix.com
Layout table for additonal information
Responsible Party: Pioneer Surgical Technology, Inc.
ClinicalTrials.gov Identifier: NCT01829997     History of Changes
Other Study ID Numbers: NB3D012012
First Submitted: April 8, 2013
First Posted: April 11, 2013
Results First Submitted: February 12, 2019
Results First Posted: April 17, 2019
Last Update Posted: April 17, 2019