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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

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.

Condition or disease Intervention/treatment Phase
Degenerative Disc Disease Spondylolisthesis, Grade 1 Retrolisthesis Device: AccuLIF expandable TLIF cage Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Multi-Center Evaluation of a Hydraulic Expandable TLIF Cage for the Treatment of Degenerative Disc Disease of the Lumbar Spine
Actual Study Start Date : June 8, 2016
Actual Primary Completion Date : January 19, 2017
Actual Study Completion Date : January 19, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: AccuLIF 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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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.

  7. 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.

  8. 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).

  9. 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.

  10. 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.

  11. 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.

  12. 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02704689


Locations
United States, Missouri
University of Missouri Health Care
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
Stryker Spine
Investigators
Principal Investigator: Theodore Choma, MD University of Missouri Health Care
  Study Documents (Full-Text)

Documents provided by Stryker Spine:

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 Posted: March 10, 2016    Key Record Dates
Results First Posted: April 24, 2018
Last Update Posted: April 24, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Intervertebral Disc Degeneration
Spondylolisthesis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis