Phase 3
Completed N=138
Safety and Efficacy Study of Healos as a Bone Replacement to Treat Degenerative Disc Disease
Source: ClinicalTrials.gov NCT00316121 ↗Enrolled (actual)
138
Serious AEs
26.1%
Results posted
Mar 2011
Primary outcomePrimary: Subject Success (Success is Defined Only if All of These Criteria Are Fulfilled) — 0; 0 Subjects
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subject Success (Success is Defined Only if All of These Criteria Are Fulfilled) |
0; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00316121). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.