Multicentre, prospective, randomised clinical survey to evaluate early fusion rate after instrumented lumbar stabilization with either MectaLIF PEEK lumbar cage or MectaLIF TiPEEK lumbar cage
Phase 4
- Conditions
- Disorders that are treated with lumbar intervertebral body fusion, such as lumbar spondylolisthesis
- Registration Number
- JPRN-UMIN000027744
- Lead Sponsor
- INCREASE Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 240
Inclusion Criteria
Not provided
Exclusion Criteria
- Patients with metabolic bone diseases, use of steroids or other drugs affecting bone metabolism. - Patients who are currently taking teriparatide or denosumab. - Patients who have taken teriparatide within 1 month. - Patients who have taken denosumab within 6 months. - Patients with neuromuscular disorders such as Parkinson's disease or athetosis. - Patients who are on dialysis. - Patients with previous spine surgeries at the level, excepting those who underwent decompression and/or nucleotomies. - Patients with restricted mobility. - Patients who are deemed unfit for participation by the Principal Investigator or the Sub-Investigators.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method