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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

Tracking Information
First Submitted Date  ICMJE February 17, 2016
First Posted Date  ICMJE March 10, 2016
Results First Submitted Date  ICMJE March 22, 2018
Results First Posted Date  ICMJE April 24, 2018
Last Update Posted Date April 24, 2018
Actual Study Start Date  ICMJE June 8, 2016
Actual Primary Completion Date January 19, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2018)
  • Post-operative Radiographic Measurements to Evaluate Segmental Lordosis as Measured by Degree of Change From Pre-operative X-rays. [ Time Frame: 24 months ]
    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. [ Time Frame: 24 months ]
    Pre-operative comparison to post-operative radiographic outcomes of disc height as measured in mm.
Original Primary Outcome Measures  ICMJE
 (submitted: March 4, 2016)
  • Post-operative Radiographic Measurements to Evaluate Segmental Lordosis as Measured by Degree of Change From Pre-operative X-rays. [ Time Frame: 24 months ]
  • Pre-operative Comparison to Post-operative Radiographic Outcomes of Disc Height as Measured in mm. [ Time Frame: 24 months ]
Change History Complete list of historical versions of study NCT02704689 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2018)
  • Surgical Outcomes: To Measure the Length of Surgery as Measured in Time of Surgery Duration. [ Time Frame: Operative Visit ]
    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. [ Time Frame: Peri-op ]
    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. [ Time Frame: Operative Visit ]
    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. [ Time Frame: 24 months ]
    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 [ Time Frame: 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 Sensory Responses in the Lower Extremities to Post-operative Findings. [ Time Frame: 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 Motors Assessments Evaluated by Straight Leg Raise, Femoral Stretch, and Strength Assessments, to Post-operative Findings. [ Time Frame: 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.
  • 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 ]
    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. [ Time Frame: 24 months ]
    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. [ Time Frame: 24 months ]
    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. [ Time Frame: 24 months ]
    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. [ Time Frame: 24 months ]
    Radiographic Outcomes: Device placement status as evaluated by x-ray and/or CT imaging.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2016)
  • Surgical Outcomes: To Measure the Length of Surgery as Measured in Time of Surgery Duration. [ Time Frame: Operative Visit ]
  • Surgical Outcomes: To Evaluate the Length of Time Hospitalized for the Index Procedure as Measured in Days. [ Time Frame: 6-weeks ]
  • Surgical Outcomes: To Measure the Amount of Blood Loss at the Time of Surgery. [ Time Frame: Operative Visit ]
  • Medical Outcomes: Incidence of Complications Associated With the Procedure and/or Device. [ Time Frame: Through 24 months ]
  • Medical Outcomes: Comparison of pre-operative neurological evaluations to post-operative findings. [ Time Frame: Through 24 months ]
  • Patient Reported Outcomes: Comparison of Pre-operative Back Pain Scores to Post-operative Levels as Measured by the (Visual Analog Scale (VAS). [ Time Frame: Through 24 months ]
  • Patient Reported Outcomes: Oswestry Disability Index Measurements for Comparison of Pre-operative to Post-operative Evaluations. [ Time Frame: Through 24 months ]
  • Patient Reported Outcomes: Evaluations of Quality of Life (QOL) as Measured by the SF-12. [ Time Frame: Through 24 months ]
  • Radiographic Outcomes: Fusion Status Evaluated by X-ray and/or CT Assessments. [ Time Frame: Through 24 months ]
  • Radiographic Outcomes: Device Placement Status as Evaluated by X-ray and/or CT Imaging. [ Time Frame: Through 24 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AccuLIF® PROSPECTIVE PATIENT OUTCOMES STUDY
Official Title  ICMJE A Prospective Multi-Center Evaluation of a Hydraulic Expandable TLIF Cage for the Treatment of Degenerative Disc Disease of the Lumbar Spine
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Degenerative Disc Disease
  • Spondylolisthesis, Grade 1
  • Retrolisthesis
Intervention  ICMJE Device: AccuLIF expandable TLIF cage
AccuLIF TL expandable interbody cage used with autogenous bone and/or allograft (cancellous or corticocancellous allograft chips) and supplemental fixation.
Study Arms  ICMJE Experimental: AccuLIF
Intervention: Device: AccuLIF expandable TLIF cage
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 17, 2017)
9
Original Estimated Enrollment  ICMJE
 (submitted: March 4, 2016)
100
Actual Study Completion Date  ICMJE January 19, 2017
Actual Primary Completion Date January 19, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subject is skeletally mature and between 18 and 70 years of age.
  2. DDD and up to Grade I spondylolisthesis or retrolisthesis, requiring decompression and arthrodesis at one or two contiguous levels between L2 and S1.
  3. No previous surgery at the same or adjacent level (other than microdiscectomy / laminectomy) at the same or adjacent level.
  4. Non-responsive to conservative (non-surgical) treatment for back pain for a minimum of 6 months.
  5. Subject understands the conditions of enrollment and is willing to sign and date the Informed Consent.
  6. Subject agrees to comply with visit schedule and completing study questionnaires.

Exclusion Criteria:

  1. Significant instability of the spine.
  2. Requires TLIF at more than 2 levels between L2 and S1.
  3. Previously undergone lumbar spine surgery (other than microdiscectomy / laminectomy) at the same or adjacent level.
  4. Younger than 18 years of age, or older than 70 years of age.
  5. BMI of 40 or greater.
  6. History of metabolic bone disease
  7. Osteoporosis
  8. Diabetes mellitus requiring daily insulin management.
  9. Subject has any of the following:

    1. Progressive neuromuscular disease; OR
    2. Autoimmune disease; OR
    3. Active malignancy within the last 15 years; OR
    4. Active hepatitis; OR
    5. AIDS, ARC, or is HIV positive; OR
    6. Syringomyelia at any spinal level; OR
    7. Any other condition that would interfere with the subject self -assessment of pain, function or quality of life.
  10. Allergy to implant materials (titanium, titanium alloy).
  11. Active systemic infection or infection localized to the site of implantation.
  12. Primary or metastatic tumors involving the spine.
  13. Open wounds or inadequate issue tissue coverage over the operative site.
  14. History of significant mental illness or mental incapacity.
  15. Pregnancy or intent to become pregnant.
  16. Participating in another investigational study for a similar purpose.
  17. Belongs to a vulnerable population that would compromise ability to provide informed consent or compliance with follow-up requirements.
  18. Smokers unwilling to cease up to 3 months post-op or recent history of alcohol or other substance abuse within the past 2 years.
  19. Workers compensation.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02704689
Other Study ID Numbers  ICMJE 2015-L-001
510(k) 132505 & K143616 ( Other Identifier: U.S. Food and Drug Administration )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Stryker Spine
Study Sponsor  ICMJE Stryker Spine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Theodore Choma, MD University of Missouri Health Care
PRS Account Stryker Spine
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP