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AccuLIF® PROSPECTIVE PATIENT OUTCOMES STUDY (APROPOS)

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ClinicalTrials.gov Identifier: NCT02704689
Recruitment Status : Terminated (Lack of subject enrollment)
First Posted : March 10, 2016
Results First Posted : April 24, 2018
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
Stryker Spine

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Degenerative Disc Disease
Spondylolisthesis, Grade 1
Retrolisthesis
Intervention Device: AccuLIF expandable TLIF cage
Enrollment 9
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AccuLIF TL
Hide Arm/Group Description All subjects enrolled were assigned to receive lumbar interbody fusion via a TLIF approach with the AccuLIF TL cage.
Period Title: Overall Study
Started 9
Completed 6
Not Completed 3
Reason Not Completed
Physician Decision             1
Study device not implanted             2
Arm/Group Title AccuLIF TL
Hide Arm/Group Description All subjects enrolled were assigned to receive lumbar interbody fusion via a TLIF approach with the AccuLIF TL cage.
Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
Total enrollment
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants
55  (12.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
3
  33.3%
Male
6
  66.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Hispanic or Latino
1
  11.1%
Not Hispanic or Latino
8
  88.9%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
  11.1%
White
8
  88.9%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 9 participants
32  (5.4)
1.Primary Outcome
Title Post-operative Radiographic Measurements to Evaluate Segmental Lordosis as Measured by Degree of Change From Pre-operative X-rays.
Hide Description Post-operative radiographic measurements to evaluate segmental lordosis as measured by degree of change from pre-operative x-rays.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title AccuLIF TL
Hide Arm/Group Description:
All subjects enrolled were assigned to receive lumbar interbody fusion via a TLIF approach with the AccuLIF TL cage.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Pre-operative Comparison to Post-operative Radiographic Outcomes of Disc Height as Measured in mm.
Hide Description Pre-operative comparison to post-operative radiographic outcomes of disc height as measured in mm.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title AccuLIF TL
Hide Arm/Group Description:
All subjects enrolled were assigned to receive lumbar interbody fusion via a TLIF approach with the AccuLIF TL cage.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Surgical Outcomes: To Measure the Length of Surgery as Measured in Time of Surgery Duration.
Hide Description Surgical Outcomes: To measure the length of surgery as measured in time of surgery duration.
Time Frame Operative Visit
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects treated with the AccuLIF TL device
Arm/Group Title AccuLIF TL
Hide Arm/Group Description:
All subjects enrolled were assigned to receive lumbar interbody fusion via a TLIF approach with the AccuLIF TL cage.
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: minutes
192  (35)
4.Secondary Outcome
Title Surgical Outcomes: To Evaluate the Length of Time Hospitalized for the Index Procedure as Measured in Days.
Hide Description Surgical Outcomes: To evaluate the length of time hospitalized for the index procedure as measured in days.
Time Frame Peri-op
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects treated with the AccuLIF TL device
Arm/Group Title AccuLIF TL
Hide Arm/Group Description:
All subjects enrolled were assigned to receive lumbar interbody fusion via a TLIF approach with the AccuLIF TL cage.
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: days
4  (2.7)
5.Secondary Outcome
Title Surgical Outcomes: To Measure the Amount of Blood Loss at the Time of Surgery.
Hide Description Surgical Outcomes: To measure the amount of blood loss at the time of surgery.
Time Frame Operative Visit
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects treated with the AccuLIF TL device
Arm/Group Title AccuLIF TL
Hide Arm/Group Description:
All subjects enrolled were assigned to receive lumbar interbody fusion via a TLIF approach with the AccuLIF TL cage.
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: cc
383  (311)
6.Secondary Outcome
Title Medical Outcomes: Incidence of Complications Associated With the Procedure and/or Device.
Hide Description Medical Outcomes: Incidence of complications associated with the procedure and/or device.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title AccuLIF TL
Hide Arm/Group Description:
All subjects enrolled were assigned to receive lumbar interbody fusion via a TLIF approach with the AccuLIF TL cage.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Medical Outcomes: Comparison of Pre-operative Neurological Reflex Evaluations in the Lower Extremities to Post-operative Findings
Hide Description Medical Outcomes: Comparison of pre-operative neurological Reflex evaluations in the lower extremities to post-operative findings
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title AccuLIF TL
Hide Arm/Group Description:
All subjects enrolled were assigned to receive lumbar interbody fusion via a TLIF approach with the AccuLIF TL cage.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Medical Outcomes: Comparison of Pre-operative Neurological Sensory Responses in the Lower Extremities to Post-operative Findings.
Hide Description Medical Outcomes: Comparison of pre-operative neurological Sensory Responses in the lower extremities to post-operative findings.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title AccuLIF TL
Hide Arm/Group Description:
All subjects enrolled were assigned to receive lumbar interbody fusion via a TLIF approach with the AccuLIF TL cage.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Medical Outcomes: Comparison of Pre-operative Neurological Motors Assessments Evaluated by Straight Leg Raise, Femoral Stretch, and Strength Assessments, to Post-operative Findings.
Hide Description Medical Outcomes: Comparison of pre-operative neurological Motors assessments evaluated by Straight Leg Raise, Femoral Stretch, and Strength assessments, to post-operative findings.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title AccuLIF TL
Hide Arm/Group Description:
All subjects enrolled were assigned to receive lumbar interbody fusion via a TLIF approach with the AccuLIF TL cage.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Patient Reported Outcomes: Comparison of Pre-operative Back Pain Scores to Post-operative Levels as Measured by the (Visual Analog Scale (VAS).
Hide Description Patient Reported Outcomes: Comparison of pre-operative back pain scores to post-operative levels as measured by the (Visual Analog Scale (VAS).
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title AccuLIF TL
Hide Arm/Group Description:
All subjects enrolled were assigned to receive lumbar interbody fusion via a TLIF approach with the AccuLIF TL cage.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Patient Reported Outcomes: Oswestry Disability Index Measurements for Comparison of Pre-operative to Post-operative Evaluations.
Hide Description Patient Reported Outcomes: Oswestry Disability Index measurements for comparison of pre-operative to post-operative evaluations.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title AccuLIF TL
Hide Arm/Group Description:
All subjects enrolled were assigned to receive lumbar interbody fusion via a TLIF approach with the AccuLIF TL cage.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Patient Reported Outcomes: Evaluations of Quality of Life (QOL) as Measured by the SF-12.
Hide Description Patient Reported Outcomes: Evaluations of Quality of Life (QOL) as measured by the SF-12.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title AccuLIF TL
Hide Arm/Group Description:
All subjects enrolled were assigned to receive lumbar interbody fusion via a TLIF approach with the AccuLIF TL cage.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Radiographic Outcomes: Fusion Status Evaluated by X-ray and/or CT Assessments.
Hide Description Radiographic Outcomes: Fusion status evaluated by x-ray and/or CT assessments.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title AccuLIF TL
Hide Arm/Group Description:
All subjects enrolled were assigned to receive lumbar interbody fusion via a TLIF approach with the AccuLIF TL cage.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Radiographic Outcomes: Device Placement Status as Evaluated by X-ray and/or CT Imaging.
Hide Description Radiographic Outcomes: Device placement status as evaluated by x-ray and/or CT imaging.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title AccuLIF TL
Hide Arm/Group Description:
All subjects enrolled were assigned to receive lumbar interbody fusion via a TLIF approach with the AccuLIF TL cage.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 6 months
Adverse Event Reporting Description Adverse Event Reporting according to clinicaltrials.gov definitions
 
Arm/Group Title AccuLIF TL
Hide Arm/Group Description All subjects enrolled were assigned to receive lumbar interbody fusion via a TLIF approach with the AccuLIF TL cage.
All-Cause Mortality
AccuLIF TL
Affected / at Risk (%)
Total   0/9 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
AccuLIF TL
Affected / at Risk (%) # Events
Total   2/9 (22.22%)    
Cardiac disorders   
Paroxysmal Supraventricular Tachycardia   1/9 (11.11%)  1
Infections and infestations   
Enterobacter Cloacae Bacteremia   1/9 (11.11%)  1
Sepsis   1/9 (11.11%)  1
Renal and urinary disorders   
Kidney Stone   1/9 (11.11%)  1
Respiratory, thoracic and mediastinal disorders   
Pulmonary Eboli and Pleural Effusions Bilaterally   1/9 (11.11%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
AccuLIF TL
Affected / at Risk (%) # Events
Total   2/9 (22.22%)    
Injury, poisoning and procedural complications   
Dural Tear   1/9 (11.11%)  1
Nervous system disorders   
Radiculitis   1/9 (11.11%)  1
Indicates events were collected by systematic assessment
A total of 100 subjects were planned for enrollment. However, this study was terminated early due to lack of enrollment with only 9 enrolled subjects and 6 treated subjects. No subjects reached the 24 month analysis visit.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Jennifer Warnke
Organization: Stryker
Phone: (201) 749-8000
Responsible Party: Stryker Spine
ClinicalTrials.gov Identifier: NCT02704689     History of Changes
Other Study ID Numbers: 2015-L-001
510(k) 132505 & K143616 ( Other Identifier: U.S. Food and Drug Administration )
First Submitted: February 17, 2016
First Posted: March 10, 2016
Results First Submitted: March 22, 2018
Results First Posted: April 24, 2018
Last Update Posted: April 24, 2018