Back to resultsAccuLIF® PROSPECTIVE PATIENT OUTCOMES STUDY (APROPOS)
Primary Purpose
Degenerative Disc Disease, Spondylolisthesis, Grade 1, Retrolisthesis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AccuLIF expandable TLIF cage
Sponsored by
About this trial
This is an interventional treatment trial for Degenerative Disc Disease
Eligibility Criteria
Inclusion Criteria:
- Subject is skeletally mature and between 18 and 70 years of age.
- DDD and up to Grade I spondylolisthesis or retrolisthesis, requiring decompression and arthrodesis at one or two contiguous levels between L2 and S1.
- No previous surgery at the same or adjacent level (other than microdiscectomy / laminectomy) at the same or adjacent level.
- Non-responsive to conservative (non-surgical) treatment for back pain for a minimum of 6 months.
- Subject understands the conditions of enrollment and is willing to sign and date the Informed Consent.
- Subject agrees to comply with visit schedule and completing study questionnaires.
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:
- Progressive neuromuscular disease; OR
- Autoimmune disease; OR
- Active malignancy within the last 15 years; OR
- Active hepatitis; OR
- AIDS, ARC, or is HIV positive; OR
- Syringomyelia at any spinal level; OR
- Any other condition that would interfere with the subject self -assessment of pain, function or quality of life.
- 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.
Sites / Locations
- University of Missouri Health Care
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AccuLIF
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
Medical Outcomes: Incidence of Complications Associated With the Procedure and/or Device.
Medical Outcomes: Incidence of complications associated with the procedure and/or device.
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
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.
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.
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).
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.
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.
Radiographic Outcomes: Fusion Status Evaluated by X-ray and/or CT Assessments.
Radiographic Outcomes: Fusion status evaluated by x-ray and/or CT assessments.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02704689
Brief Title
AccuLIF® PROSPECTIVE PATIENT OUTCOMES STUDY
Acronym
APROPOS
Official Title
A Prospective Multi-Center Evaluation of a Hydraulic Expandable TLIF Cage for the Treatment of Degenerative Disc Disease of the Lumbar Spine
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Why Stopped
Lack of subject enrollment
Study Start Date
June 8, 2016 (Actual)
Primary Completion Date
January 19, 2017 (Actual)
Study Completion Date
January 19, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stryker Spine
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Disc Disease, Spondylolisthesis, Grade 1, Retrolisthesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AccuLIF
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
AccuLIF expandable TLIF cage
Intervention Description
AccuLIF TL expandable interbody cage used with autogenous bone and/or allograft (cancellous or corticocancellous allograft chips) and supplemental fixation.
Primary Outcome Measure Information:
Title
Post-operative Radiographic Measurements to Evaluate Segmental Lordosis as Measured by Degree of Change From Pre-operative X-rays.
Description
Post-operative radiographic measurements to evaluate segmental lordosis as measured by degree of change from pre-operative x-rays.
Time Frame
24 months
Title
Pre-operative Comparison to Post-operative Radiographic Outcomes of Disc Height as Measured in mm.
Description
Pre-operative comparison to post-operative radiographic outcomes of disc height as measured in mm.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Surgical Outcomes: To Measure the Length of Surgery as Measured in Time of Surgery Duration.
Description
Surgical Outcomes: To measure the length of surgery as measured in time of surgery duration.
Time Frame
Operative Visit
Title
Surgical Outcomes: To Evaluate the Length of Time Hospitalized for the Index Procedure as Measured in Days.
Description
Surgical Outcomes: To evaluate the length of time hospitalized for the index procedure as measured in days.
Time Frame
Peri-op
Title
Surgical Outcomes: To Measure the Amount of Blood Loss at the Time of Surgery.
Description
Surgical Outcomes: To measure the amount of blood loss at the time of surgery.
Time Frame
Operative Visit
Title
Medical Outcomes: Incidence of Complications Associated With the Procedure and/or Device.
Description
Medical Outcomes: Incidence of complications associated with the procedure and/or device.
Time Frame
24 months
Title
Medical Outcomes: Comparison of Pre-operative Neurological Reflex Evaluations in the Lower Extremities to Post-operative Findings
Description
Medical Outcomes: Comparison of pre-operative neurological Reflex evaluations in the lower extremities to post-operative findings
Time Frame
24 months
Title
Medical Outcomes: Comparison of Pre-operative Neurological Sensory Responses in the Lower Extremities to Post-operative Findings.
Description
Medical Outcomes: Comparison of pre-operative neurological Sensory Responses in the lower extremities to post-operative findings.
Time Frame
24 months
Title
Medical Outcomes: Comparison of Pre-operative Neurological Motors Assessments Evaluated by Straight Leg Raise, Femoral Stretch, and Strength Assessments, to Post-operative Findings.
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
Title
Patient Reported Outcomes: Comparison of Pre-operative Back Pain Scores to Post-operative Levels as Measured by the (Visual Analog Scale (VAS).
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
Title
Patient Reported Outcomes: Oswestry Disability Index Measurements for Comparison of Pre-operative to Post-operative Evaluations.
Description
Patient Reported Outcomes: Oswestry Disability Index measurements for comparison of pre-operative to post-operative evaluations.
Time Frame
24 months
Title
Patient Reported Outcomes: Evaluations of Quality of Life (QOL) as Measured by the SF-12.
Description
Patient Reported Outcomes: Evaluations of Quality of Life (QOL) as measured by the SF-12.
Time Frame
24 months
Title
Radiographic Outcomes: Fusion Status Evaluated by X-ray and/or CT Assessments.
Description
Radiographic Outcomes: Fusion status evaluated by x-ray and/or CT assessments.
Time Frame
24 months
Title
Radiographic Outcomes: Device Placement Status as Evaluated by X-ray and/or CT Imaging.
Description
Radiographic Outcomes: Device placement status as evaluated by x-ray and/or CT imaging.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject is skeletally mature and between 18 and 70 years of age.
DDD and up to Grade I spondylolisthesis or retrolisthesis, requiring decompression and arthrodesis at one or two contiguous levels between L2 and S1.
No previous surgery at the same or adjacent level (other than microdiscectomy / laminectomy) at the same or adjacent level.
Non-responsive to conservative (non-surgical) treatment for back pain for a minimum of 6 months.
Subject understands the conditions of enrollment and is willing to sign and date the Informed Consent.
Subject agrees to comply with visit schedule and completing study questionnaires.
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:
Progressive neuromuscular disease; OR
Autoimmune disease; OR
Active malignancy within the last 15 years; OR
Active hepatitis; OR
AIDS, ARC, or is HIV positive; OR
Syringomyelia at any spinal level; OR
Any other condition that would interfere with the subject self -assessment of pain, function or quality of life.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theodore Choma, MD
Organizational Affiliation
University of Missouri Health Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri Health Care
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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AccuLIF® PROSPECTIVE PATIENT OUTCOMES STUDY
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