Trial Outcomes & Findings for Clinical and Radiological Evaluation of Patients With DDD Following TLIF With 3-D Printed Titanium Cage (NCT NCT03018392)
NCT ID: NCT03018392
Last Updated: 2022-09-07
Results Overview
Fusion status at 1 year post-operatively was graded as - fused (best outcome), progressing, or pseudoarthrosis (failed fusion)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
1 year
Results posted on
2022-09-07
Participant Flow
Participant milestones
| Measure |
Tritanium
TLIF with Tritanium® PL cage and pedicle screw fixation
Stryker Tritanium Spinal System: open transforaminal lumbar interbody fusion (TLIF) utilizing the Stryker Tritanium cages with pedicle screw fixation according to instructions for use and package labeling for on-label indications
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Tritanium
n=20 Participants
TLIF with Tritanium® PL cage and pedicle screw fixation
Stryker Tritanium Spinal System: open transforaminal lumbar interbody fusion (TLIF) utilizing the Stryker Tritanium cages with pedicle screw fixation according to instructions for use and package labeling for on-label indications
|
|---|---|
|
Age, Continuous
|
67.5 years
STANDARD_DEVIATION 7.8 • n=20 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=20 Participants
|
|
BMI
|
31.6 kg/m^2
STANDARD_DEVIATION 4 • n=20 Participants
|
PRIMARY outcome
Timeframe: 1 yearFusion status at 1 year post-operatively was graded as - fused (best outcome), progressing, or pseudoarthrosis (failed fusion)
Outcome measures
| Measure |
Tritanium
n=20 Participants
TLIF with Tritanium® PL cage and pedicle screw fixation
Stryker Tritanium Spinal System: open transforaminal lumbar interbody fusion (TLIF) utilizing the Stryker Tritanium cages with pedicle screw fixation according to instructions for use and package labeling for on-label indications
|
|---|---|
|
Fusion Rate
Pseudoarthrosis
|
1 Participants
|
|
Fusion Rate
Fused
|
19 Participants
|
|
Fusion Rate
Progressing
|
0 Participants
|
Adverse Events
Tritanium
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tritanium
n=20 participants at risk
TLIF with Tritanium® PL cage and pedicle screw fixation
Stryker Tritanium Spinal System: open transforaminal lumbar interbody fusion (TLIF) utilizing the Stryker Tritanium cages with pedicle screw fixation according to instructions for use and package labeling for on-label indications
|
|---|---|
|
Surgical and medical procedures
Extension of fusion
|
5.0%
1/20 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Tritanium
n=20 participants at risk
TLIF with Tritanium® PL cage and pedicle screw fixation
Stryker Tritanium Spinal System: open transforaminal lumbar interbody fusion (TLIF) utilizing the Stryker Tritanium cages with pedicle screw fixation according to instructions for use and package labeling for on-label indications
|
|---|---|
|
Product Issues
Cage Fracture
|
5.0%
1/20 • Number of events 1 • 1 year
|
Additional Information
Research Projects Director
Bone and Joint Clinic of Baton Rouge
Phone: 2254218207
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60