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| ID | Type | Description | Link |
|---|---|---|---|
| 510(k) 132505 & K143616 | Other Identifier | U.S. Food and Drug Administration |
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Lack of subject enrollment
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This is a post-market clinical study of the AccuLIF expandable transforaminal lumbar interbody fusion (TLIF) cage in patients requiring surgery for degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis, at one or two levels, between L2 and S1.
Study evaluations will be evaluated pre-operatively and at 6-weeks, 3-months, 6-months, 12-months and 24-months post-operatively to assess clinical outcomes, patient reported outcomes and radiographic status.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AccuLIF | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AccuLIF expandable TLIF cage | Device | AccuLIF TL expandable interbody cage used with autogenous bone and/or allograft (cancellous or corticocancellous allograft chips) and supplemental fixation. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Radiographic Measurements to Evaluate Segmental Lordosis as Measured by Degree of Change From Pre-operative X-rays. | Post-operative radiographic measurements to evaluate segmental lordosis as measured by degree of change from pre-operative x-rays. | 24 months |
| Pre-operative Comparison to Post-operative Radiographic Outcomes of Disc Height as Measured in mm. | Pre-operative comparison to post-operative radiographic outcomes of disc height as measured in mm. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical Outcomes: To Measure the Length of Surgery as Measured in Time of Surgery Duration. | Surgical Outcomes: To measure the length of surgery as measured in time of surgery duration. | Operative Visit |
| Surgical Outcomes: To Evaluate the Length of Time Hospitalized for the Index Procedure as Measured in Days. |
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Inclusion Criteria:
Exclusion Criteria:
Significant instability of the spine.
Requires TLIF at more than 2 levels between L2 and S1.
Previously undergone lumbar spine surgery (other than microdiscectomy / laminectomy) at the same or adjacent level.
Younger than 18 years of age, or older than 70 years of age.
BMI of 40 or greater.
History of metabolic bone disease
Osteoporosis
Diabetes mellitus requiring daily insulin management.
Subject has any of the following:
Allergy to implant materials (titanium, titanium alloy).
Active systemic infection or infection localized to the site of implantation.
Primary or metastatic tumors involving the spine.
Open wounds or inadequate issue tissue coverage over the operative site.
History of significant mental illness or mental incapacity.
Pregnancy or intent to become pregnant.
Participating in another investigational study for a similar purpose.
Belongs to a vulnerable population that would compromise ability to provide informed consent or compliance with follow-up requirements.
Smokers unwilling to cease up to 3 months post-op or recent history of alcohol or other substance abuse within the past 2 years.
Workers compensation.
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| Name | Affiliation | Role |
|---|---|---|
| Theodore Choma, MD | University of Missouri Health Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri Health Care | Columbia | Missouri | 65212 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | AccuLIF TL | All subjects enrolled were assigned to receive lumbar interbody fusion via a TLIF approach with the AccuLIF TL cage. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Total enrollment
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| ID | Title | Description |
|---|---|---|
| BG000 | AccuLIF TL | All subjects enrolled were assigned to receive lumbar interbody fusion via a TLIF approach with the AccuLIF TL cage. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Post-operative Radiographic Measurements to Evaluate Segmental Lordosis as Measured by Degree of Change From Pre-operative X-rays. | Post-operative radiographic measurements to evaluate segmental lordosis as measured by degree of change from pre-operative x-rays. | 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. | Posted | 24 months |
|
6 months
Adverse Event Reporting according to clinicaltrials.gov definitions
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AccuLIF TL | All subjects enrolled were assigned to receive lumbar interbody fusion via a TLIF approach with the AccuLIF TL cage. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Paroxysmal Supraventricular Tachycardia | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Radiculitis | Nervous system disorders | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Warnke | Stryker | (201) 749-8000 | jennifer.warnke@stryker.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 21, 2015 | Mar 22, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| D013168 | Spondylolisthesis |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013169 | Spondylolysis |
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Surgical Outcomes: To evaluate the length of time hospitalized for the index procedure as measured in days. |
| Peri-op |
| Surgical Outcomes: To Measure the Amount of Blood Loss at the Time of Surgery. | Surgical Outcomes: To measure the amount of blood loss at the time of surgery. | Operative Visit |
| Medical Outcomes: Incidence of Complications Associated With the Procedure and/or Device. | Medical Outcomes: Incidence of complications associated with the procedure and/or device. | 24 months |
| Medical Outcomes: Comparison of Pre-operative Neurological Reflex Evaluations in the Lower Extremities to Post-operative Findings | Medical Outcomes: Comparison of pre-operative neurological Reflex evaluations in the lower extremities to post-operative findings | 24 months |
| Medical Outcomes: Comparison of Pre-operative Neurological Sensory Responses in the Lower Extremities to Post-operative Findings. | Medical Outcomes: Comparison of pre-operative neurological Sensory Responses in the lower extremities to post-operative findings. | 24 months |
| Medical Outcomes: Comparison of Pre-operative Neurological Motors Assessments Evaluated by Straight Leg Raise, Femoral Stretch, and Strength Assessments, to Post-operative Findings. | Medical Outcomes: Comparison of pre-operative neurological Motors assessments evaluated by Straight Leg Raise, Femoral Stretch, and Strength assessments, to post-operative findings. | 24 months |
| Patient Reported Outcomes: Comparison of Pre-operative Back Pain Scores to Post-operative Levels as Measured by the (Visual Analog Scale (VAS). | Patient Reported Outcomes: Comparison of pre-operative back pain scores to post-operative levels as measured by the (Visual Analog Scale (VAS). | 24 months |
| Patient Reported Outcomes: Oswestry Disability Index Measurements for Comparison of Pre-operative to Post-operative Evaluations. | Patient Reported Outcomes: Oswestry Disability Index measurements for comparison of pre-operative to post-operative evaluations. | 24 months |
| Patient Reported Outcomes: Evaluations of Quality of Life (QOL) as Measured by the SF-12. | Patient Reported Outcomes: Evaluations of Quality of Life (QOL) as measured by the SF-12. | 24 months |
| Radiographic Outcomes: Fusion Status Evaluated by X-ray and/or CT Assessments. | Radiographic Outcomes: Fusion status evaluated by x-ray and/or CT assessments. | 24 months |
| Radiographic Outcomes: Device Placement Status as Evaluated by X-ray and/or CT Imaging. | Radiographic Outcomes: Device placement status as evaluated by x-ray and/or CT imaging. | 24 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
| Units | Counts |
|---|
| Participants |
|
| Primary | Pre-operative Comparison to Post-operative Radiographic Outcomes of Disc Height as Measured in mm. | Pre-operative comparison to post-operative radiographic outcomes of disc height as measured in mm. | 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. | Posted | 24 months |
|
|
| Secondary | Surgical Outcomes: To Measure the Length of Surgery as Measured in Time of Surgery Duration. | Surgical Outcomes: To measure the length of surgery as measured in time of surgery duration. | Subjects treated with the AccuLIF TL device | Posted | Mean | Standard Deviation | minutes | Operative Visit |
|
|
|
| Secondary | Surgical Outcomes: To Evaluate the Length of Time Hospitalized for the Index Procedure as Measured in Days. | Surgical Outcomes: To evaluate the length of time hospitalized for the index procedure as measured in days. | Subjects treated with the AccuLIF TL device | Posted | Mean | Standard Deviation | days | Peri-op |
|
|
|
| Secondary | Surgical Outcomes: To Measure the Amount of Blood Loss at the Time of Surgery. | Surgical Outcomes: To measure the amount of blood loss at the time of surgery. | Subjects treated with the AccuLIF TL device | Posted | Mean | Standard Deviation | cc | Operative Visit |
|
|
|
| Secondary | Medical Outcomes: Incidence of Complications Associated With the Procedure and/or Device. | Medical Outcomes: Incidence of complications associated with the procedure and/or device. | 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. | Posted | 24 months |
|
|
| Secondary | Medical Outcomes: Comparison of Pre-operative Neurological Reflex Evaluations in the Lower Extremities to Post-operative Findings | Medical Outcomes: Comparison of pre-operative neurological Reflex evaluations in the lower extremities to post-operative findings | 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. | Posted | 24 months |
|
|
| Secondary | Medical Outcomes: Comparison of Pre-operative Neurological Sensory Responses in the Lower Extremities to Post-operative Findings. | Medical Outcomes: Comparison of pre-operative neurological Sensory Responses in the lower extremities to post-operative findings. | 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. | Posted | 24 months |
|
|
| Secondary | Medical Outcomes: Comparison of Pre-operative Neurological Motors Assessments Evaluated by Straight Leg Raise, Femoral Stretch, and Strength Assessments, to Post-operative Findings. | Medical Outcomes: Comparison of pre-operative neurological Motors assessments evaluated by Straight Leg Raise, Femoral Stretch, and Strength assessments, to post-operative findings. | 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. | Posted | 24 months |
|
|
| Secondary | Patient Reported Outcomes: Comparison of Pre-operative Back Pain Scores to Post-operative Levels as Measured by the (Visual Analog Scale (VAS). | Patient Reported Outcomes: Comparison of pre-operative back pain scores to post-operative levels as measured by the (Visual Analog Scale (VAS). | 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. | Posted | 24 months |
|
|
| Secondary | Patient Reported Outcomes: Oswestry Disability Index Measurements for Comparison of Pre-operative to Post-operative Evaluations. | Patient Reported Outcomes: Oswestry Disability Index measurements for comparison of pre-operative to post-operative evaluations. | 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. | Posted | 24 months |
|
|
| Secondary | Patient Reported Outcomes: Evaluations of Quality of Life (QOL) as Measured by the SF-12. | Patient Reported Outcomes: Evaluations of Quality of Life (QOL) as measured by the SF-12. | 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. | Posted | 24 months |
|
|
| Secondary | Radiographic Outcomes: Fusion Status Evaluated by X-ray and/or CT Assessments. | Radiographic Outcomes: Fusion status evaluated by x-ray and/or CT assessments. | 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. | Posted | 24 months |
|
|
| Secondary | Radiographic Outcomes: Device Placement Status as Evaluated by X-ray and/or CT Imaging. | Radiographic Outcomes: Device placement status as evaluated by x-ray and/or CT imaging. | 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. | Posted | 24 months |
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| 0 |
| 9 |
| 2 |
| 9 |
| 2 |
| 9 |
| Enterobacter Cloacae Bacteremia | Infections and infestations | Systematic Assessment |
|
| Pulmonary Eboli and Pleural Effusions Bilaterally | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Kidney Stone | Renal and urinary disorders | Systematic Assessment |
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| Sepsis | Infections and infestations | Systematic Assessment |
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| Dural Tear | Injury, poisoning and procedural complications | Systematic Assessment |
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| D055009 |
| Spondylosis |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |