Trial Outcomes & Findings for Assessment of nanOss Bioactive 3D in the Posterolateral Spine (NCT NCT01829997)

Last Updated: 2019-04-17

Results Overview

Fusion is defined as the presence of bridging trabecular bone and less than 3mm of translational motion and less than 5mm of angular motion.

Recruitment status

COMPLETED

Study phase

Target enrollment

22 participants

Primary outcome timeframe

12 months

Results posted on

2019-04-17

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	22
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assessment of nanOss Bioactive 3D in the Posterolateral Spine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	nanOss Bioactive 3D BVF n=22 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	60 years n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	nanOss Bioactive 3D BVF n=18 Participants 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.
Number of Patients With Fusion	16 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	nanOss Bioactive 3D BVF n=16 Participants 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.
Number of Participants With Improvement in Quality of Life	16 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	nanOss Bioactive 3D BVF n=18 Participants 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.
Number of Participants With Improvement in Pain Scores	18 Participants

SECONDARY outcome

Timeframe: 12 months

Population: Data was not collected

Number of participants with decreased usage of pain medication after surgery

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 Months

Population: Data was not collected

Time frame in which patient returned to work after surgery

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Overall satisfaction with the procedure

Outcome measures

Outcome measures
Measure	nanOss Bioactive 3D BVF n=18 Participants 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.
Satisfaction With Surgery	18 Participants

Adverse Events

nanOss Bioactive 3D BVF

Serious events: 3 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	nanOss Bioactive 3D BVF n=22 participants at risk 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.
Musculoskeletal and connective tissue disorders Continued leg pain	4.5% 1/22 • 2 years 0
Musculoskeletal and connective tissue disorders Increased bilateral leg pain	4.5% 1/22 • 2 years 0
Musculoskeletal and connective tissue disorders Right iliac implant pain	4.5% 1/22 • 2 years 0

Other adverse events

Other adverse events
Measure	nanOss Bioactive 3D BVF n=22 participants at risk 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.
Musculoskeletal and connective tissue disorders Right leg pain	31.8% 7/22 • 2 years 0
Musculoskeletal and connective tissue disorders Bilateral leg pain	9.1% 2/22 • 2 years 0
Musculoskeletal and connective tissue disorders Continued leg pain	4.5% 1/22 • 2 years 0
Musculoskeletal and connective tissue disorders Lower back pain	9.1% 2/22 • 2 years 0
Musculoskeletal and connective tissue disorders Hernia	4.5% 1/22 • 2 years 0
Musculoskeletal and connective tissue disorders Neck pain	4.5% 1/22 • 2 years 0
Musculoskeletal and connective tissue disorders Arm tingling	9.1% 2/22 • 2 years 0
General disorders Bleeding hemorrhoids	4.5% 1/22 • 2 years 0
General disorders Altered mental status	4.5% 1/22 • 2 years 0
General disorders CSF Leak	4.5% 1/22 • 2 years 0

Additional Information

Kristina Shine

RTI Surgical

Phone: 386-418-8888

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place