JPRN-UMIN000027744
Not yet recruiting
Phase 4
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 - Study to evaluate early fusion rate using MectaLIF PEEK or MectaLIF TiPEEK lumbar cage
INCREASE Co., Ltd.0 sites240 target enrollmentJune 15, 2017
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Disorders that are treated with lumbar intervertebral body fusion, such as lumbar spondylolisthesis
- Sponsor
- INCREASE Co., Ltd.
- Enrollment
- 240
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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