Clinical trial NCT02704689: AccuLIF® PROSPECTIVE PATIENT OUTCOMES STUDY
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
Overall status: TERMINATED
Phase: NA
Conditions: Degenerative Disc Disease
Spondylolisthesis, Grade 1
Retrolisthesis
Lead sponsor: Stryker Spine
Sponsor class: INDUSTRY
First posted: 2016-03-10
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Post-operative Radiographic Measurements to Evaluate Segmental Lordosis as Measured by Degree of Change From Pre-operative X-rays.
timeFrame: 24 months
measure: Pre-operative Comparison to Post-operative Radiographic Outcomes of Disc Height as Measured in mm.
timeFrame: 24 months
Secondary outcomes:
measure: Surgical Outcomes: To Measure the Length of Surgery as Measured in Time of Surgery Duration.
timeFrame: Operative Visit
measure: Surgical Outcomes: To Evaluate the Length of Time Hospitalized for the Index Procedure as Measured in Days.
timeFrame: Peri-op
measure: Surgical Outcomes: To Measure the Amount of Blood Loss at the Time of Surgery.
timeFrame: Operative Visit
measure: Medical Outcomes: Incidence of Complications Associated With the Procedure and/or Device.
timeFrame: 24 months
measure: Medical Outcomes: Comparison of Pre-operative Neurological Reflex Evaluations in the Lower Extremities to Post-operative Findings
timeFrame: 24 months
measure: Medical Outcomes: Comparison of Pre-operative Neurological Sensory Responses in the Lower Extremities to Post-operative Findings.
timeFrame: 24 months
measure: Medical Outcomes: Comparison of Pre-operative Neurological Motors Assessments Evaluated by Straight Leg Raise, Femoral Stretch, and Strength Assessments, to Post-operative Findings.
timeFrame: 24 months
measure: Patient Reported Outcomes: Comparison of Pre-operative Back Pain Scores to Post-operative Levels as Measured by the (Visual Analog Scale (VAS).
timeFrame: 24 months
measure: Patient Reported Outcomes: Oswestry Disability Index Measurements for Comparison of Pre-operative to Post-operative Evaluations.
timeFrame: 24 months
measure: Patient Reported Outcomes: Evaluations of Quality of Life (QOL) as Measured by the SF-12.
timeFrame: 24 months
measure: Radiographic Outcomes: Fusion Status Evaluated by X-ray and/or CT Assessments.
timeFrame: 24 months
measure: Radiographic Outcomes: Device Placement Status as Evaluated by X-ray and/or CT Imaging.
timeFrame: 24 months
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri Health Care
state: Missouri
Study officials:
affiliation: University of Missouri Health Care
name: Theodore Choma, MD
role: PRINCIPAL_INVESTIGATOR
References: