Trial Outcomes & Findings for AccuLIF® PROSPECTIVE PATIENT OUTCOMES STUDY (NCT NCT02704689)

NCT ID: NCT02704689

Last Updated: 2018-04-24

Results Overview

Post-operative radiographic measurements to evaluate segmental lordosis as measured by degree of change from pre-operative x-rays.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 9 participants
• Primary outcome timeframe: 24 months
• Results posted on: 2018-04-24

Participant Flow

Participant milestones

Measure	AccuLIF TL All subjects enrolled were assigned to receive lumbar interbody fusion via a TLIF approach with the AccuLIF TL cage.
Overall Study STARTED	9
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	AccuLIF TL All subjects enrolled were assigned to receive lumbar interbody fusion via a TLIF approach with the AccuLIF TL cage.
Overall Study Physician Decision	1
Overall Study Study device not implanted	2

Baseline Characteristics

AccuLIF® PROSPECTIVE PATIENT OUTCOMES STUDY

Baseline characteristics by cohort

Measure	AccuLIF TL n=9 Participants All subjects enrolled were assigned to receive lumbar interbody fusion via a TLIF approach with the AccuLIF TL cage.
Age, Continuous	55 years STANDARD_DEVIATION 12.1 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 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	1 Participants n=5 Participants
Race (NIH/OMB) White	8 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
BMI	32 kg/m2 STANDARD_DEVIATION 5.4 • n=5 Participants

PRIMARY outcome

Timeframe: 24 months

Population: The Primary Outcome Measures were going to be analyzed at the 24 month visit. However, this study was terminated early due to lack of enrollment and no subjects reached the 24 month analysis visit. There is, therefore, no data to summarize for this Primary Outcome Measure.

Post-operative radiographic measurements to evaluate segmental lordosis as measured by degree of change from pre-operative x-rays.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 24 months

Population: The Primary Outcome Measures were going to be analyzed at the 24 month visit. However, this study was terminated early due to lack of enrollment and no subjects reached the 24 month analysis visit. There is, therefore, no data to summarize for this Primary Outcome Measure.

Pre-operative comparison to post-operative radiographic outcomes of disc height as measured in mm.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Operative Visit

Population: Subjects treated with the AccuLIF TL device

Surgical Outcomes: To measure the length of surgery as measured in time of surgery duration.

Outcome measures

Measure	AccuLIF TL n=6 Participants All subjects enrolled were assigned to receive lumbar interbody fusion via a TLIF approach with the AccuLIF TL cage.
Surgical Outcomes: To Measure the Length of Surgery as Measured in Time of Surgery Duration.	192 minutes Standard Deviation 35

SECONDARY outcome

Timeframe: Peri-op

Population: Subjects treated with the AccuLIF TL device

Surgical Outcomes: To evaluate the length of time hospitalized for the index procedure as measured in days.

Outcome measures

Measure	AccuLIF TL n=6 Participants All subjects enrolled were assigned to receive lumbar interbody fusion via a TLIF approach with the AccuLIF TL cage.
Surgical Outcomes: To Evaluate the Length of Time Hospitalized for the Index Procedure as Measured in Days.	4 days Standard Deviation 2.7

SECONDARY outcome

Timeframe: Operative Visit

Population: Subjects treated with the AccuLIF TL device

Surgical Outcomes: To measure the amount of blood loss at the time of surgery.

Outcome measures

Measure	AccuLIF TL n=6 Participants All subjects enrolled were assigned to receive lumbar interbody fusion via a TLIF approach with the AccuLIF TL cage.
Surgical Outcomes: To Measure the Amount of Blood Loss at the Time of Surgery.	383 cc Standard Deviation 311

SECONDARY outcome

Timeframe: 24 months

Population: The Secondary Outcome Measures were going to be analyzed at the 24 month visit. However, this study was terminated early due to lack of enrollment and no subjects reached the 24 month analysis visit. There is, therefore, no data to summarize for this Secondary Outcome Measure.

Medical Outcomes: Incidence of complications associated with the procedure and/or device.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Population: The Secondary Outcome Measures were going to be analyzed at the 24 month visit. However, this study was terminated early due to lack of enrollment and no subjects reached the 24 month analysis visit. There is, therefore, no data to summarize for this Secondary Outcome Measure.

Medical Outcomes: Comparison of pre-operative neurological Reflex evaluations in the lower extremities to post-operative findings

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Population: The Secondary Outcome Measures were going to be analyzed at the 24 month visit. However, this study was terminated early due to lack of enrollment and no subjects reached the 24 month analysis visit. There is, therefore, no data to summarize for this Secondary Outcome Measure.

Medical Outcomes: Comparison of pre-operative neurological Sensory Responses in the lower extremities to post-operative findings.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Population: The Secondary Outcome Measures were going to be analyzed at the 24 month visit. However, this study was terminated early due to lack of enrollment and no subjects reached the 24 month analysis visit. There is, therefore, no data to summarize for this Secondary Outcome Measure.

Medical Outcomes: Comparison of pre-operative neurological Motors assessments evaluated by Straight Leg Raise, Femoral Stretch, and Strength assessments, to post-operative findings.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Population: The Secondary Outcome Measures were going to be analyzed at the 24 month visit. However, this study was terminated early due to lack of enrollment and no subjects reached the 24 month analysis visit. There is, therefore, no data to summarize for this Secondary Outcome Measure.

Patient Reported Outcomes: Comparison of pre-operative back pain scores to post-operative levels as measured by the (Visual Analog Scale (VAS).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Population: The Secondary Outcome Measures were going to be analyzed at the 24 month visit. However, this study was terminated early due to lack of enrollment and no subjects reached the 24 month analysis visit. There is, therefore, no data to summarize for this Secondary Outcome Measure.

Patient Reported Outcomes: Oswestry Disability Index measurements for comparison of pre-operative to post-operative evaluations.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Population: The Secondary Outcome Measures were going to be analyzed at the 24 month visit. However, this study was terminated early due to lack of enrollment and no subjects reached the 24 month analysis visit. There is, therefore, no data to summarize for this Secondary Outcome Measure.

Patient Reported Outcomes: Evaluations of Quality of Life (QOL) as measured by the SF-12.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Population: The Secondary Outcome Measures were going to be analyzed at the 24 month visit. However, this study was terminated early due to lack of enrollment and no subjects reached the 24 month analysis visit. There is, therefore, no data to summarize for this Secondary Outcome Measure.

Radiographic Outcomes: Fusion status evaluated by x-ray and/or CT assessments.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Population: The Secondary Outcome Measures were going to be analyzed at the 24 month visit. However, this study was terminated early due to lack of enrollment and no subjects reached the 24 month analysis visit. There is, therefore, no data to summarize for this Secondary Outcome Measure.

Radiographic Outcomes: Device placement status as evaluated by x-ray and/or CT imaging.

Outcome measures

Outcome data not reported

Adverse Events

AccuLIF TL

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	AccuLIF TL n=9 participants at risk All subjects enrolled were assigned to receive lumbar interbody fusion via a TLIF approach with the AccuLIF TL cage.
Cardiac disorders Paroxysmal Supraventricular Tachycardia	11.1% 1/9 • Number of events 1 • 6 months Adverse Event Reporting according to clinicaltrials.gov definitions
Infections and infestations Enterobacter Cloacae Bacteremia	11.1% 1/9 • Number of events 1 • 6 months Adverse Event Reporting according to clinicaltrials.gov definitions
Respiratory, thoracic and mediastinal disorders Pulmonary Eboli and Pleural Effusions Bilaterally	11.1% 1/9 • Number of events 1 • 6 months Adverse Event Reporting according to clinicaltrials.gov definitions
Renal and urinary disorders Kidney Stone	11.1% 1/9 • Number of events 1 • 6 months Adverse Event Reporting according to clinicaltrials.gov definitions
Infections and infestations Sepsis	11.1% 1/9 • Number of events 1 • 6 months Adverse Event Reporting according to clinicaltrials.gov definitions

Other adverse events

Measure	AccuLIF TL n=9 participants at risk All subjects enrolled were assigned to receive lumbar interbody fusion via a TLIF approach with the AccuLIF TL cage.
Nervous system disorders Radiculitis	11.1% 1/9 • Number of events 1 • 6 months Adverse Event Reporting according to clinicaltrials.gov definitions
Injury, poisoning and procedural complications Dural Tear	11.1% 1/9 • Number of events 1 • 6 months Adverse Event Reporting according to clinicaltrials.gov definitions

Additional Information

Jennifer Warnke

Stryker

Phone: (201) 749-8000

Email: jennifer.warnke@stryker.com

Results disclosure agreements

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