AccuLIF® PROSPECTIVE PATIENT OUTCOMES STUDY (NCT02704689) | Clinical Trial Compass
TerminatedNot Applicable
AccuLIF® PROSPECTIVE PATIENT OUTCOMES STUDY
Stopped: Lack of subject enrollment
United States9 participantsStarted 2016-06-08
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
âś“. Subject is skeletally mature and between 18 and 70 years of age.
âś“. DDD and up to Grade I spondylolisthesis or retrolisthesis, requiring decompression and arthrodesis at one or two contiguous levels between L2 and S1.
âś“. No previous surgery at the same or adjacent level (other than microdiscectomy / laminectomy) at the same or adjacent level.
âś“. Non-responsive to conservative (non-surgical) treatment for back pain for a minimum of 6 months.
âś“. Subject understands the conditions of enrollment and is willing to sign and date the Informed Consent.
âś“. Subject agrees to comply with visit schedule and completing study questionnaires.
Exclusion criteria
âś•. Significant instability of the spine.
âś•. Requires TLIF at more than 2 levels between L2 and S1.
âś•. Previously undergone lumbar spine surgery (other than microdiscectomy / laminectomy) at the same or adjacent level.
âś•. Younger than 18 years of age, or older than 70 years of age.
âś•. BMI of 40 or greater.
âś•. History of metabolic bone disease
âś•. Osteoporosis
What they're measuring
1
Post-operative Radiographic Measurements to Evaluate Segmental Lordosis as Measured by Degree of Change From Pre-operative X-rays.
Timeframe: 24 months
2
Pre-operative Comparison to Post-operative Radiographic Outcomes of Disc Height as Measured in mm.