OsteoporosisOMCNCT05981222
Osteo Match Cages Versus PEEK Cages in Osteoporotic Patients
An observational study of Osteoporosis and Degenerative Lumbar Disease, run by Peking University Third Hospital at 1 site in China.
Trial summary
This is a multicenter, prospective cohort study. The osteoporotic patients requiring posterior lumbar interbody fusion(LIF) with cages are prospectively enrolled and followed up. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoporosis, Degenerative Lumbar Disease, Degeneration Spine
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 1 Aug 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The osteoporotic patients requiring lumbar interbody fusion with cages for lumbar degenerative diseases are invited to participate in the study.
Who may be able to join
- 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
Who cannot join
- the surgical plan includes any unconventional techniques used to strengthen the fixation, such as augmentation of the pedicle screw with bone cement
- lumbar spondylolisthesis of ≥II degree
- lumbar scoliosis of >20° or imbalance of spinal alignment
- history of lumbar fusion surgery
- cervical myelopathy, thoracic spinal stenosis, motor neuron disease,tuberculosis of spine,spinal tumor
- vertebral fracture within interbody fusion segement
- ASA of ≥IV
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
Official title: Biomechanical-matched Titanium Cages(Osteo Match) Versus PEEK Cages in Osteoporotic Lumbar Spine: a Multicenter, Prospective Cohort Study
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.
Read the detailed description
Interbody fusion cages are widely used for the surgical treatment of degenerative lumbar diseases, which can stabilize the spine and promote solid fusion. However, because of population aging and the high rate of osteoporosis in the elderly with lumbar degenerative diseases, the cage subsidence and failure of fusion have been frequently reported. The biomechanical strength (such as elasticity modulus) of routine PEEK cages is mismatched with osteoporotic bone, leading to cage subsidence and nonunion.
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. However, most of the titanium cages still have much higher biomechanical strength than the osteoporotic bone. The new titanium cages named Osteo Match has been first clinically used in Peking University Third Hospital in China. The elastic modulus of Osteo Match cage is matched with that of lumbar spine with different degrees of osteoporosis. Therefore, we hypothesize that patients undergoing LIF with Osteo Match cages can achieve lower rate of cage subsidence and higher rate of lumbar fusion than those using PEEK cages.
The osteoporotic patients requiring posterior lumbar interbody fusion with cages 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 by DXA, CT Hounsfield units, or QCT), 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, CTand certain questions about the clinical outcomes.
The patients used Osteo Match cages are compared with those using conventional PEEK cages. The primary endpoints are the subsidence rate and fusion rate at 6 months follow-up. The secondary endpoints are the subsidence rate and fusion rate at other time point of follow-up , and the clinical outcomes(ODI/JOA/VAS) at every follow-up.
- Keywords
- Osteoporosis, Cage subsidence, Lumbar fusion, Osteo Match
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Osteo Match cage | Patients undergoing posterior lumbar interbody fusion with Osteo Match Cages | |
| Peek Cage | Patients undergoing posterior lumbar interbody fusion with PEEK Cages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cage subsidence rate
The presence of cage subsidence > 2mm at x-ray or CT images.
Measured: 6 months
Fusion rate
The presence of continuous fusion mass at bone graft site in CT scans and absence of intervertebral mobility on lateral flextion-extension x-ray images.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start1 Aug 2023
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Weishi Li, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05981222
- Sponsor's protocol ID
- 2019-397-04
- Acronym
- OMC
- Status last verified
- Jan 2025
- First submitted
- 1 Aug 2023
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zou D, Yue L, Fan Z, Zhao Y, Leng H, Sun Z, Li W. Biomechanical Analysis of Lumbar Interbody Fusion Cages With Various Elastic Moduli in Osteoporotic and Non-osteoporotic Lumbar Spine: A Finite Element Analysis. Global Spine J. 2024 Sep;14(7):2053-2061. doi: 10.1177/21925682231166612. Epub 2023 May 3.
PubMed 37132375McGilvray KC, Easley J, Seim HB, Regan D, Berven SH, Hsu WK, Mroz TE, Puttlitz CM. Bony ingrowth potential of 3D-printed porous titanium alloy: a direct comparison of interbody cage materials in an in vivo ovine lumbar fusion model. Spine J. 2018 Jul;18(7):1250-1260. doi: 10.1016/j.spinee.2018.02.018. Epub 2018 Feb 26.
PubMed 29496624Li P, Jiang W, Yan J, Hu K, Han Z, Wang B, Zhao Y, Cui G, Wang Z, Mao K, Wang Y, Cui F. A novel 3D printed cage with microporous structure and in vivo fusion function. J Biomed Mater Res A. 2019 Jul;107(7):1386-1392. doi: 10.1002/jbm.a.36652. Epub 2019 Mar 18.
PubMed 30724479Goldstein CL, Brodke DS, Choma TJ. Surgical Management of Spinal Conditions in the Elderly Osteoporotic Spine. Neurosurgery. 2015 Oct;77 Suppl 4:S98-107. doi: 10.1227/NEU.0000000000000948.
PubMed 26378363Zou D, Jiang S, Zhou S, Sun Z, Zhong W, Du G, Li W. Prevalence of Osteoporosis in Patients Undergoing Lumbar Fusion for Lumbar Degenerative Diseases: A Combination of DXA and Hounsfield Units. Spine (Phila Pa 1976). 2020 Apr 1;45(7):E406-E410. doi: 10.1097/BRS.0000000000003284.
PubMed 31725127