NCT05981222Enrolling by invitation
Osteo Match Cages Versus PEEK Cages in Osteoporotic Patients
Biomechanical-matched Titanium Cages(Osteo Match) Versus PEEK Cages in Osteoporotic Lumbar Spine: a Multicenter, Prospective Cohort Study
Source: ClinicalTrials.gov · Last updated 22 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This is a multicenter, prospective cohort study. The osteoporotic patients requiring posterior lumbar interbody fusion(LIF) with cages are prospectively enrolled and followed up. The patients undergoing LIF with the biomechanical-matched 3D-printed titanium cages (Osteo Match) are compared with those using routine PEEK cages. The hypothesis is that the use of Osteo Match cages can reduce the rate of cage subsidence and increase the rate of lumbar fusion in osteoporotic patients.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 1500 (estimated)
- First submitted
- 1 Aug 2023
- Start date
- 1 Aug 2023
- Primary completion date
- 1 Aug 2026
- Lead sponsor
- Peking University Third Hospital
- Diseases
- Osteoporosis
- NCT number
- NCT05981222
What you commit to
- Study type: Observational
- Planned participants: 1500
- From 1 Aug 2023 to the primary completion date, 1 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- the surgical plan includes any unconventional techniques used to strengthen the fixation, such as augmentation of the pedicle screw with bone cement
Other illness
- history of lumbar fusion surgery
- cervical myelopathy, thoracic spinal stenosis, motor neuron disease,tuberculosis of spine,spinal tumor
Other
- lumbar spondylolisthesis of ≥II degree
- lumbar scoliosis of \>20° or imbalance of spinal alignment
- vertebral fracture within interbody fusion segement
- ASA of ≥IV
Who the study is looking for
- aged≥ 50 years old
- lumbar degenerative diseases requiring lumbar fusion with pedicle screw fixation, such as degenerative lumbar spinal stenosis, degenerative lumbar spondylolisthesis.
- no response to nonoperative treatment of at least 3 months
- osteoporosis diagnosed by any method for bone mineral density evaluation, such as DXA, QCTor CT Hounsfield units
- requiring lumbar interbody fusion with cages within L3-S1
- the type of fusion cage has been chosen by the patients
- informed consent
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.