AccuLIF® PROSPECTIVE PATIENT OUTCOMES STUDY (APROPOS)

A Prospective Multi-Center Evaluation of a Hydraulic Expandable TLIF Cage for the Treatment of Degenerative Disc Disease of the Lumbar Spine

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 Overview

• Status: Terminated
• Conditions: Degenerative Disc Disease; Spondylolisthesis, Grade 1; Retrolisthesis
• Intervention / Treatment: Device: AccuLIF expandable TLIF cage

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
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri Health Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Stryker Spine
• Investigators: Principal Investigator: Theodore Choma, MD, University of Missouri Health Care

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2016
• Primary Completion (Actual): January 19, 2017
• Study Completion (Actual): January 19, 2017

Study Registration Dates

• First Submitted: February 17, 2016
• First Submitted That Met QC Criteria: March 4, 2016
• First Posted (Estimate): March 10, 2016

Study Record Updates

• Last Update Posted (Actual): April 24, 2018
• Last Update Submitted That Met QC Criteria: April 20, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Intervertebral Disc Degeneration; Spondylolisthesis
• Other Study ID Numbers: 2015-L-001; 510(k) 132505 & K143616 (Other Identifier: U.S. Food and Drug Administration)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No