Clinical investigation to examine the bone fusion by using PEEK interbody cage or titanium coated PEEK interbody cage for posterior lumbar interbody fusion, a multicenter, randomized, open-label, parallel-group trial
Not Applicable
- Conditions
- umbar canal stenosis, lumbar disc herniation, lumbar radiculopathy, spondylosis, spondylolisthesis, lumbar kyphoscoliosis, lumbar scoliosis, and lumbar kyphosis which need posterior interbody fusion
- Registration Number
- JPRN-UMIN000022618
- Lead Sponsor
- Department of Orthopaedic Surgery, Hamamatsu University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
Not provided
Exclusion Criteria
1.Patients 19 years of age or younger at the time of signing consent form 2.Patients whom the attending physician investigator has determined to be unsuitable for the conduct of the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method By X-ray or CT image at 2M,4M,6M,9M and 12M after surgery 1.Fusion rate 2.Rate of intervertebral disc narrowing and instability 3.Occurrence rate of screw loosening
- Secondary Outcome Measures
Name Time Method Improvement of ADL and QO