Trial Outcomes & Findings for Lumbar Fusion With Nexxt Spine 3D-Printed Titanium Interbody Cages (NCT NCT03647501)
NCT ID: NCT03647501
Last Updated: 2023-06-15
Results Overview
Interbody fusion will be graded using the Brantigan, Steffee, Fraser (BSF) Scale which classifies fusion between the interbody cage and adjacent bone on a scale of 1-3 where a higher score indicates a better outcome. The grades are defined as follows: Brantigan, Steffee, Fraser-Grade 1 (BSF-1) indicates radiographical pseudarthrosis, Brantigan, Steffee, Fraser-Grade 2 (BSF-2) is defined by radiographical locked pseudarthrosis, and Brantigan, Steffee, Fraser-Grade 3 (BSF-3) is radiographical fusion, indicating the best outcome. The subject will be considered a success if fusion is a Grade BSF-3 at 6 months.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
53 participants
Primary outcome timeframe
6 months post-operatively
Results posted on
2023-06-15
Participant Flow
Participant milestones
| Measure |
3D-printed Titanium Cage
Subjects enrolled in this arm will have the Nexxt Spine Nexxt MatrixxTM 3D-printed titanium cage (interbody cage) implanted at each level of 1 or 2-level lumbar arthrodesis procedures. All constructs will be supplemented with a pedicle screw system (Depuy Synthes Expedium) cleared for lumbar spinal fusion.
Interbody cage (titanium): Subject will be implanted with a 3D-printed titanium cage during their lumbar interbody fusion surgery.
|
Poly-ether-ether-ketone (PEEK) Cage
Subjects enrolled in this arm will have the HonourTM poly-ether-ether-ketone (PEEK) cage (interbody cage) implanted at each level of 1 or 2-level lumbar arthrodesis procedures. All constructs will be supplemented with a pedicle screw system (Depuy Synthes Expedium) cleared for lumbar spinal fusion.
Interbody cage (PEEK): Subject will be implanted with a poly-ether-ether-ketone (PEEK) cage during their lumbar interbody fusion surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
28
|
|
Overall Study
COMPLETED
|
24
|
26
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
3D-printed Titanium Cage
Subjects enrolled in this arm will have the Nexxt Spine Nexxt MatrixxTM 3D-printed titanium cage (interbody cage) implanted at each level of 1 or 2-level lumbar arthrodesis procedures. All constructs will be supplemented with a pedicle screw system (Depuy Synthes Expedium) cleared for lumbar spinal fusion.
Interbody cage (titanium): Subject will be implanted with a 3D-printed titanium cage during their lumbar interbody fusion surgery.
|
Poly-ether-ether-ketone (PEEK) Cage
Subjects enrolled in this arm will have the HonourTM poly-ether-ether-ketone (PEEK) cage (interbody cage) implanted at each level of 1 or 2-level lumbar arthrodesis procedures. All constructs will be supplemented with a pedicle screw system (Depuy Synthes Expedium) cleared for lumbar spinal fusion.
Interbody cage (PEEK): Subject will be implanted with a poly-ether-ether-ketone (PEEK) cage during their lumbar interbody fusion surgery.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Lumbar Fusion With Nexxt Spine 3D-Printed Titanium Interbody Cages
Baseline characteristics by cohort
| Measure |
3D-printed Titanium Cage
n=25 Participants
Subjects enrolled in this arm will have the Nexxt Spine Nexxt MatrixxTM 3D-printed titanium cage (interbody cage) implanted at each level of 1 or 2-level lumbar arthrodesis procedures. All constructs will be supplemented with a pedicle screw system (Depuy Synthes Expedium) cleared for lumbar spinal fusion.
Interbody cage (titanium): Subject will be implanted with a 3D-printed titanium cage during their lumbar interbody fusion surgery.
|
Poly-ether-ether-ketone (PEEK) Cage
n=28 Participants
Subjects enrolled in this arm will have the HonourTM poly-ether-ether-ketone (PEEK) cage (interbody cage) implanted at each level of 1 or 2-level lumbar arthrodesis procedures. All constructs will be supplemented with a pedicle screw system (Depuy Synthes Expedium) cleared for lumbar spinal fusion.
Interbody cage (PEEK): Subject will be implanted with a poly-ether-ether-ketone (PEEK) cage during their lumbar interbody fusion surgery.
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
28 participants
n=7 Participants
|
53 participants
n=5 Participants
|
|
Current Smoker
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months post-operativelyInterbody fusion will be graded using the Brantigan, Steffee, Fraser (BSF) Scale which classifies fusion between the interbody cage and adjacent bone on a scale of 1-3 where a higher score indicates a better outcome. The grades are defined as follows: Brantigan, Steffee, Fraser-Grade 1 (BSF-1) indicates radiographical pseudarthrosis, Brantigan, Steffee, Fraser-Grade 2 (BSF-2) is defined by radiographical locked pseudarthrosis, and Brantigan, Steffee, Fraser-Grade 3 (BSF-3) is radiographical fusion, indicating the best outcome. The subject will be considered a success if fusion is a Grade BSF-3 at 6 months.
Outcome measures
| Measure |
3D-printed Titanium Cage
n=34 Fusion Levels (Number of cages used)
Subjects enrolled in this arm will have the Nexxt Spine Nexxt MatrixxTM 3D-printed titanium cage (interbody cage) implanted at each level of 1 or 2-level lumbar arthrodesis procedures. All constructs will be supplemented with a pedicle screw system (Depuy Synthes Expedium) cleared for lumbar spinal fusion.
Interbody cage (titanium): Subject will be implanted with a 3D-printed titanium cage during their lumbar interbody fusion surgery.
|
Poly-ether-ether-ketone (PEEK) Cage
n=40 Fusion Levels (Number of cages used)
Subjects enrolled in this arm will have the HonourTM poly-ether-ether-ketone (PEEK) cage (interbody cage) implanted at each level of 1 or 2-level lumbar arthrodesis procedures. All constructs will be supplemented with a pedicle screw system (Depuy Synthes Expedium) cleared for lumbar spinal fusion.
Interbody cage (PEEK): Subject will be implanted with a poly-ether-ether-ketone (PEEK) cage during their lumbar interbody fusion surgery.
|
|---|---|---|
|
Interbody Radiographic Fusion Rate
Level with BSF Grade 3
|
27 Cages/Spinal Levels
|
10 Cages/Spinal Levels
|
|
Interbody Radiographic Fusion Rate
Level with BSF Grade 2
|
6 Cages/Spinal Levels
|
24 Cages/Spinal Levels
|
|
Interbody Radiographic Fusion Rate
Level with BSF Grade 1
|
0 Cages/Spinal Levels
|
6 Cages/Spinal Levels
|
|
Interbody Radiographic Fusion Rate
Level with Cage Removed- Grade Not Applicable
|
1 Cages/Spinal Levels
|
0 Cages/Spinal Levels
|
SECONDARY outcome
Timeframe: 12 months post-operativelyPopulation: Overall Number of Participants and Units Analyzed relied on available imaging at one year: Flexion extension films at one year were available for 18 (69.2%) PEEK patients and 16 (66.7%) of titanium patients.
Secondary measures of effectiveness will be determined by timing of fusion observed in X-rays post-operatively. Fusion at one year was defined as a difference in cobb angle of the operated levels between flexion and extension views. More than 2 degrees of change between views indicated non-union at one year.
Outcome measures
| Measure |
3D-printed Titanium Cage
n=24 Surgical Levels
Subjects enrolled in this arm will have the Nexxt Spine Nexxt MatrixxTM 3D-printed titanium cage (interbody cage) implanted at each level of 1 or 2-level lumbar arthrodesis procedures. All constructs will be supplemented with a pedicle screw system (Depuy Synthes Expedium) cleared for lumbar spinal fusion.
Interbody cage (titanium): Subject will be implanted with a 3D-printed titanium cage during their lumbar interbody fusion surgery.
|
Poly-ether-ether-ketone (PEEK) Cage
n=29 Surgical Levels
Subjects enrolled in this arm will have the HonourTM poly-ether-ether-ketone (PEEK) cage (interbody cage) implanted at each level of 1 or 2-level lumbar arthrodesis procedures. All constructs will be supplemented with a pedicle screw system (Depuy Synthes Expedium) cleared for lumbar spinal fusion.
Interbody cage (PEEK): Subject will be implanted with a poly-ether-ether-ketone (PEEK) cage during their lumbar interbody fusion surgery.
|
|---|---|---|
|
Post-operative Timing of Fusion
Surgical levels over 2 degrees of change (non-union/non-fusion)
|
5 Surgical Levels
|
12 Surgical Levels
|
|
Post-operative Timing of Fusion
Surgical levels under 2 degrees of change (fusion)
|
19 Surgical Levels
|
17 Surgical Levels
|
Adverse Events
3D-printed Titanium Cage
Serious events: 7 serious events
Other events: 3 other events
Deaths: 0 deaths
Poly-ether-ether-ketone (PEEK) Cage
Serious events: 6 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
3D-printed Titanium Cage
n=25 participants at risk
Subjects enrolled in this arm will have the Nexxt Spine Nexxt MatrixxTM 3D-printed titanium cage (interbody cage) implanted at each level of 1 or 2-level lumbar arthrodesis procedures. All constructs will be supplemented with a pedicle screw system (Depuy Synthes Expedium) cleared for lumbar spinal fusion.
Interbody cage (titanium): Subject will be implanted with a 3D-printed titanium cage during their lumbar interbody fusion surgery.
|
Poly-ether-ether-ketone (PEEK) Cage
n=28 participants at risk
Subjects enrolled in this arm will have the HonourTM poly-ether-ether-ketone (PEEK) cage (interbody cage) implanted at each level of 1 or 2-level lumbar arthrodesis procedures. All constructs will be supplemented with a pedicle screw system (Depuy Synthes Expedium) cleared for lumbar spinal fusion.
Interbody cage (PEEK): Subject will be implanted with a poly-ether-ether-ketone (PEEK) cage during their lumbar interbody fusion surgery.
|
|---|---|---|
|
Blood and lymphatic system disorders
nausea, lactic acidosis
|
4.0%
1/25 • Number of events 1 • 1 year
|
0.00%
0/28 • 1 year
|
|
Infections and infestations
cellulitis or gout flair up
|
4.0%
1/25 • Number of events 1 • 1 year
|
7.1%
2/28 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
4.0%
1/25 • Number of events 1 • 1 year
|
0.00%
0/28 • 1 year
|
|
General disorders
Syncope, Fall
|
4.0%
1/25 • Number of events 1 • 1 year
|
0.00%
0/28 • 1 year
|
|
Surgical and medical procedures
Avulsed right bicep tendon - Repair
|
4.0%
1/25 • Number of events 1 • 1 year
|
0.00%
0/28 • 1 year
|
|
Surgical and medical procedures
thyroidectomy
|
4.0%
1/25 • Number of events 1 • 1 year
|
0.00%
0/28 • 1 year
|
|
Infections and infestations
wound dehiscense
|
4.0%
1/25 • Number of events 1 • 1 year
|
0.00%
0/28 • 1 year
|
|
Nervous system disorders
acute encephalopathy
|
0.00%
0/25 • 1 year
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
inguinal hernia repair with mesh
|
0.00%
0/25 • 1 year
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
General disorders
Joint Pain and Swelling
|
0.00%
0/25 • 1 year
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cardiac Catheterization/ Coronary Bypass Graft
|
0.00%
0/25 • 1 year
|
3.6%
1/28 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
3D-printed Titanium Cage
n=25 participants at risk
Subjects enrolled in this arm will have the Nexxt Spine Nexxt MatrixxTM 3D-printed titanium cage (interbody cage) implanted at each level of 1 or 2-level lumbar arthrodesis procedures. All constructs will be supplemented with a pedicle screw system (Depuy Synthes Expedium) cleared for lumbar spinal fusion.
Interbody cage (titanium): Subject will be implanted with a 3D-printed titanium cage during their lumbar interbody fusion surgery.
|
Poly-ether-ether-ketone (PEEK) Cage
n=28 participants at risk
Subjects enrolled in this arm will have the HonourTM poly-ether-ether-ketone (PEEK) cage (interbody cage) implanted at each level of 1 or 2-level lumbar arthrodesis procedures. All constructs will be supplemented with a pedicle screw system (Depuy Synthes Expedium) cleared for lumbar spinal fusion.
Interbody cage (PEEK): Subject will be implanted with a poly-ether-ether-ketone (PEEK) cage during their lumbar interbody fusion surgery.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
12.0%
3/25 • Number of events 4 • 1 year
|
14.3%
4/28 • Number of events 4 • 1 year
|
|
Nervous system disorders
Symptomatic Radiculopathy - Back and Leg Pain
|
0.00%
0/25 • 1 year
|
17.9%
5/28 • Number of events 6 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place