ISRCTN12002403
Active, not recruiting
Phase 4
Prospective evaluation of clinical and radiographic outcomes after lumbar lateral interbody fusion surgery using a JULIET® Ti LL interbody fusion cage
Spineart (Switzerland)0 sites74 target enrollmentMay 12, 2022
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Patients with symptomatic degenerative lumbar disc diseases (DDD) and spondylosisthesis, functionally disabling discogenic low back pain that does not improve after conservative care
- Sponsor
- Spineart (Switzerland)
- Enrollment
- 74
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Skeletally mature subjects, \=18 years old
- •2\. Indicated DDD defined as discogenic back pain with degeneration of the disc confirmed radiographically and by patient history
- •2\.1\. DDD, or
- •2\.2\. DDD with up to grade I Spondylolisthesis, or
- •2\.3\. DDD with up to grade I Retrolisthesis
- •3\. Psychosocially, mentally, and physically able to fully comply with the protocol including adhering to follow\-up schedule and filling out questionnaires.
- •4\. Written voluntary informed consent signed
Exclusion Criteria
- •1\. Mental illness
- •2\. Infection
- •3\. Severely damaged bone structures that could prevent stable implantation of the cage (bone density in SD \=\-2\.5\)
- •4\. Neuromuscular or vascular disorders or illness
- •5\. Inadequate activity (inability to follow postoperative rehab restriction)
- •6\. Pregnancy
- •7\. Bone tumor in the region of the implant
- •8\. Fractures (same level treated or adjacent level: active, non\-consolidated, or old osteoporotic fracture)
Outcomes
Primary Outcomes
Not specified
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