A Prospective, Multicenter, Randomized Study Comparing the Use of HEALOS® to Autograft in a Transforaminal Lumbar Interbody Fusion (TLIF) Approach
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 138
- Locations
- 17
- Primary Endpoint
- Subject Success (Success is Defined Only if All of These Criteria Are Fulfilled)
Study Overview
Brief Summary
The purpose of this study is to determine the safety and effectiveness of HEALOS compared with autograft using the transforaminal lumbar interbody fusion (TLIF) method.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Persistent back and/or leg pain refractory to 6 months of non-surgical therapy
- •Male or female 18 to 70 years of age (inclusive)
- •Objective evidence of significant disc degeneration at one or two adjacent lumbar level(s) from L2/L3 to L5/S1
Exclusion Criteria
- •Significant disc degeneration at more than two adjacent levels
- •Greater than Grade II spondylolisthesis
- •Prior fusion surgery of the lumbar spine (prior discectomies and intradiscal electrothermal therapy [IDET] are allowed)
- •Insulin-dependent diabetes mellitus
- •Pregnant or lactating, or wishes to become pregnant within the 24 month duration of the study
Outcomes
Primary Outcomes
Subject Success (Success is Defined Only if All of These Criteria Are Fulfilled)
Time Frame: 24 months
Success is bridging bone, slip of study level versus adjacent levels less than 3 millimeters, angulation less than 5 degrees, 15 point increase in Oswestry Disability Index (ODI) (how back/leg trouble affects activities of daily living), no new problems in motor strength in legs, presence/absence of pain on leg raise, sensation intact on thigh/leg/foot reflexes of the knees/ankles, no permanent/serious complications, no revision/removal/reoperation/supplemental fixation. The ODI is on a 6 point scale from 0 (no pain/no impact on duties) to 5 (worst pain ever/unable to perform duties).
Secondary Outcomes
No secondary outcomes reported