Trial Outcomes & Findings for A Comparison of Stryker's Tritanium Posterior Lumbar Cage and PEEK Implant (NCT NCT03817606)

NCT ID: NCT03817606

Last Updated: 2023-01-10

Results Overview

CT and X-ray imaging will be obtained at study visits and Fusion Success will be defined by the following criteria: no lucent area around the implant; no presences of herniated disk, central stenosis, lateral recess stenosis, foraminal stenosis, facet anthropathy; no fracture of the device, graft or vertebra; visible bone formation in or about the graft material; less than 3 degrees of inter-segmental position change on flexion and extension views; presence of subsidence: a migration of more than 3mm into the adjacent vertebra; and the proportion of bridging bone visually estimated over the surface area of the joint

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 4 participants
• Primary outcome timeframe: 12 Months
• Results posted on: 2023-01-10

Participant Flow

Participant milestones

Measure	Tritanium Posterior Lumbar Cage Surgical placement of the Tritanium Posterior Lumbar Cage Tritanium Posterior Lumbar Cage: Placement of Tritanium Posterior Lumbar Cage via TLIF procedure	AVS PEEK UniLIF Surgical placement of the AVS PEEK UniLIF Posterior Lumbar Cage AVS UniLIF PEEK Posterior Lumbar Cage: Placement of AVS UniLIF PEEK Posterior Lumbar Cage via TLIF procedure.
Overall Study STARTED	2	2
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The patients were enrolled; however, the study was not completed. No participants completed the study. There was no data to analyze.

Baseline characteristics by cohort

Measure	AVS PEEK UniLIF n=2 Participants Surgical placement of the AVS PEEK UniLIF Posterior Lumbar Cage AVS UniLIF PEEK Posterior Lumbar Cage: Placement of AVS UniLIF PEEK Posterior Lumbar Cage via TLIF procedure. Study not completed due to COVID-19	Tritanium Posterior Lumbar Cage n=2 Participants Surgical placement of the Tritanium Posterior Lumbar Cage Tritanium Posterior Lumbar Cage: Placement of Tritanium Posterior Lumbar Cage via TLIF procedure Study not completed due to COVID-19.	Total n=4 Participants Total of all reporting groups
Age, Continuous	64 years n=5 Participants	53.5 years n=7 Participants	58.75 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 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	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	2 Participants n=5 Participants • The patients were enrolled; however, the study was not completed. No participants completed the study. There was no data to analyze.	2 Participants n=7 Participants • The patients were enrolled; however, the study was not completed. No participants completed the study. There was no data to analyze.	4 Participants n=5 Participants • The patients were enrolled; however, the study was not completed. No participants completed the study. There was no data to analyze.

PRIMARY outcome

Timeframe: 12 Months

Population: Four patients were initially enrolled; however, due to COVID-19, study enrollment was suspended and patient follow up was limited to standard of care. The study was not continued. No data to analyze.

CT and X-ray imaging will be obtained at study visits and Fusion Success will be defined by the following criteria: no lucent area around the implant; no presences of herniated disk, central stenosis, lateral recess stenosis, foraminal stenosis, facet anthropathy; no fracture of the device, graft or vertebra; visible bone formation in or about the graft material; less than 3 degrees of inter-segmental position change on flexion and extension views; presence of subsidence: a migration of more than 3mm into the adjacent vertebra; and the proportion of bridging bone visually estimated over the surface area of the joint

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation

Population: Four patients were initially enrolled; however due to COVID-19 enrollment was suspended and patient follow up was limited to standard of care. The study was not continued. No Data to Analyze

Change in low back pain as indicated by Visual Analogue Scale (VAS). The VAS measures subjects' self-reported pain level on a 100 mm line on which the subject indicates their level of pain, where 0 is no pain and 100 is worst imaginable pain.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation

Population: Four patients were initially enrolled; however due to COVID-19 enrollment was suspended and patient follow up was limited to standard of care. The study was not continued. No Data to Analyze

Change in Oswestry Disability Index (ODI) score. The ODI assesses disability related to lower back pain using a Likert 0 to 5 scale. There are 10 sections to the assessment, and the scores are represented as a percentage ranging from 0 (no disability) to 100 (completely disabled).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation.

Population: Four patients were initially enrolled; however due to COVID-19 enrollment was suspended and patient follow up was limited to standard of care. The study was not continued. No Data to Analyze

Change in perception of quality of life, as measured by Short Form 36 Health Survey (SF-36 PCS). The SF-36 PCS is a 36-item patient reported health questionnaire to measure perceived quality of life across 8 domains. Higher scores indicate higher quality of life, and lower scores indicate lower quality of life. Scores range from 5 (poor physical function) to 80 (excellent clinical function).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation

Population: Four patients were initially enrolled; however due to COVID-19 enrollment was suspended and patient follow up was limited to standard of care. The study was not continued. No Data to Analyze

Subjects who were unable to work due to their back pain who return to work.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation

Population: Four patients were initially enrolled; however due to COVID-19 enrollment was suspended and patient follow up was limited to standard of care. The study was not continued. No Data to Analyze

Amount of time to full ambulation without assistance for study participants who had no or partial ambulation at baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks; 3 months; 6 months; and 12 months post operation

Population: Four patients were initially enrolled; however due to COVID-19 enrollment was suspended and patient follow up was limited to standard of care. The study was not continued. No Data to Analyze

Any event meeting the Serious Adverse Event reporting criteria detailed in the study protocol occurring at the following time intervals: TLIF procedure, hospital recovery and discharge, and 6 weeks-, 3 months-, 6 months- and 12 months post operation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation

Population: Four patients were initially enrolled; however due to COVID-19 enrollment was suspended and patient follow up was limited to standard of care. The study was not continued. No Data to Analyze

Change in perception of quality of life, as measured by the EuroQol-5d (EQ-5d). The EuroQol-5d is a five question broad quality of life measure that can be combined into a single index and represents current health. A score of 0.0 is the worst imaginable health while a score of 1.0 would be the best imaginable health.

Outcome measures

Outcome data not reported

Adverse Events

Tritanium Posterior Lumbar Cage

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

AVS PEEK UniLIF

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Cynthia Koehn, Clinical Research Nurse

Riverside Medical Center

Phone: 815-933-1671

Email: ckoehn@rhc.net

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place