An observational study in Osteoporosis, Degenerative Disc Disease and Degenerative Lumbar Spinal Stenosis, sponsored by Peking University Third Hospital. Status unknown at 1 site in China. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2021-09-17.
Sponsored by Peking University Third Hospital · Observational
This is a prospective,observational single-center study. The osteoporotic patients requiring posterior lumbar interbody fusion(PLIF) with cages at the lowest fusion segment are prospectively enrolled and followed up. The patients undergoing PLIF with the 3D-printed porous titanium alloy cages are compared with those using PEEK cages. The hypothesis is that the use of 3D-printed porous titanium alloy cages can reduce the rate of pedicle screw loosening and increase the rate of lumbar fusion in osteoporotic patients.
Pedicle screw fixation is a widely used technique for the surgical treatment of degenerative lumbar diseases, which can stabilize the spine before solid fusion and restore spinal balance. However, because of population aging and the high rate of osteoporosis in the elderly with lumbar degenerative diseases, the pedicle screw loosening has become a frequently reported complication. The bone-screw interface in osteoporotic spine is unstable, leading to reduced pull-out force and cut-out force. Most of the previous studies only focused on the methods used to directly strengthen the pedicle screws, few of them explored the feasibility of reducing the loosening rate by accelerating the lumbar fusion precess.
The 3D-printed porous titanium alloy cages have been proved to have advantages in speeding up and enhancing the lumbar fusion over conventional PEEK cages. Therefore, we hypothesize that patients undergoing PLIF with 3D-printed cages can achieve lumbar fusion earlier than those using PEEK cages, thus the 3D-printed cages can reduce the load on pedicle screws sooner than PEEK cages. Finally, the 3D-printed cages can reduce the loosening rate and increase the fusion rate.
The osteoporotic patients requiring posterior lumbar interbody fusion(PLIF) with cages at the lowest fusion segment are prospectively enrolled and followed up. The researchers will invite appropriate patients to participate in the study after their surgical plans are determined. General patients data are collected after informed consent, such as age, gender, weight, height, bone mineral density measured in T-scores and Hounsfield units, detailed surgical plans, and etc. They are followed up at 3, 6, 12, and 24 months according to our clinical routine, including lumbar x-ray and certain questions about the clinical outcomes. In addition, this study requires the patients to have lumbar CT scans when the fusion status is unclear in x-ray, especially for the 6 months follow-up.
The patients undergoing PLIF with the 3D-printed porous titanium alloy cages are compared with those using conventional PEEK cages. The primary endpoints are the loosening rate and fusion rate at 6 months follow-up. The secondary endpoints are the loosening rate and fusion rate at other time point of follow-up , and the clinical outcomes(ODI and VAS) at every follow-up.
1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.
This study's planned enrollment of 90 is below the median of 174 across 446 observational studies indexed under Osteoporosis.
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In the orthopaedic department of the Peking University Third Hospital, the osteoporotic in-patients requiring lumbar fusion with pedicle screw for lumbar degenerative diseases are invited to participate in the study.
Exclusion Criteria:
Patients undergoing posterior lumbar interbody fusion with 3D-printed Porous Titanium Alloy Cages at the lowest fusion segment
Patients undergoing posterior lumbar interbody fusion with PEEK Cages at the lowest fusion segment
Pedicle screw loosening rate at the lowest instrumented vertebrae
The presence of radiolucent zones of ≥ 1mm thick around the pedicle screws, broken screws, or obvious screw back-out and cut-out on x-ray images.
Time frame: 6 months
Fusion rate at the lowest fusion level
The presence of continuous fusion mass at bone graft site in CT scans and less than 3 degree of intervertebral mobility on lateral flextion-extension x-ray images.
Time frame: 6 months
Pedicle screw loosening rate at the lowest instrumented vertebrae
The presence of radiolucent zones of ≥ 1mm thick around the pedicle screws, broken screws, or obvious screw back-out and cut-out on x-ray images.
Time frame: 3 months;12 months; 24 months
Fusion rate at the lowest fusion level
The presence of continuous fusion mass at bone graft site in CT scans and less than 3 degree of intervertebral mobility on lateral flextion-extension x-ray images.
Time frame: 3 months;12 months; 24 months
Disability
The Oswestry Disability Index (ODI) (0-100) is used to assess disability.
Time frame: 3 months; 6 months;12 months; 24 months
Back pain
The Visual Analog Scale (VAS 0-10) is used the evaluate back pain.
Time frame: 3 months; 6 months;12 months; 24 months
Leg pain
The Visual Analog Scale (VAS 0-10) is used the evaluate leg pain.
Time frame: 3 months; 6 months;12 months; 24 months
Plan to share: Yes — We will make the clinical study report available for half a year after the publication of the results of the study.
Supporting information: Csr
This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Peking University Third Hospital