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Feasibility study of cellular titanium cages in lumbar spondylodesis using posterolateral interbody fusion procedure


- candidate number28277
- NTR NumberNTR6870
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-nov-2017
- Secondary IDsNL64253.091.17 METC
- Public TitleFeasibility study of cellular titanium cages in lumbar spondylodesis using posterolateral interbody fusion procedure
- Scientific TitleFeasibility study of cellular titanium cages in lumbar spondylodesis using posterolateral interbody fusion procedure
- ACRONYM3D PLIF feasibility
- hypothesisThe bony-bridging-score is feasible to use to asses bon ingrowth on a CT-scan at 1 year follow up after postero lateral interbody fusion (PLIF) surgery.
the degree of radiological bone ingrowth in patients who are eligible for a lumbar spinal fusion with PLIF (EITŪ) cages.
- Healt Condition(s) or Problem(s) studiedPosterolateral interbody fusion (PLIF) surgery, Spondylosis
- Inclusion criteria- Posterior spinal fusion with PLIF procedure (L2-S1), maximal 2 levels
- Aged between 25 and 75 years
- Chronic low back pain with or without leg pain
- Failed conservative treatment at least six months prior to the posterior spinal fusion
- Willingness to participate
- Able to read and speak Dutch
- Exclusion criteria- Previous lumbar fusion at the same level
- Smoking
- BMI >30
- Osteoporosis
- Active, local or systemic infection (rheumatoid arthritis, spondylitis, previous spinal infections, previous spinal trauma)
- Physical, emotional, neurological comorbidities intervening with the compliance monitoring (drug or alcohol abuse, mental illness, general neurological disorders such as Parkinson's, Multiple Sclerosis)
- Oncological or hematological disorders
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jan-2018
- planned closingdate1-jan-2019
- Target number of participants15
- InterventionsPosterolateral interbody fusion surgery
- Primary outcomeBone ingroth in cages assessed on CT with bony bridging score
- Secondary outcomeFunctional status, quality of life, pain intenstity in beack and leg, satisfaction

Adverse evants: e.g. complications, re-operation
- Timepointspreoprative, 3 months and 1 year

Primary outcome is only assessed at1 year follow up.
- Trial web siteNA
- statusplanned
- CONTACT FOR PUBLIC QUERIESMSc Miranda van Hooff
- CONTACT for SCIENTIFIC QUERIESMSc Miranda van Hooff
- Sponsor/Initiator Sint Maartenskliniek Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
European Institute of Innovation and Technology (EIT)
- Publicationsplanned in future
- Brief summaryA posterior lumbar Interbody fusion (PLIF) is an effective surgical technique to reduce symptoms and improve function in patients with spondylolisthesis. The PLIF technique is performed with bilateral interbody cages, like the titanium cages of EITŪ. These cages are 3D printed and simulate the bone structure and bone geometry. The surface for bone Ingrowth is large and could result in bone ingrowth and fusion. It is expected that due to the bone growth into the cage a solid stable bony fusion can be achieved. If it appears that inter corporal fusion with EITŪ cages is possible, the use of posterolateral allografts in the PLIF technique will be unnecessary and the risk of subsidence of the cages will be reduced. In literature little is known about valid and reliable measuring and evaluating bone growth. The 'bony-bridging-score' is developed to evaluate the anterior lumbar interbody fusion (ALIF) procedure with PEEK cages. However, it is unknown whether this outcome measure is also useful for the PLIF procedure with 3D printed Titanium EIT cages. A single center prospective case series including 15 patients is planned to evaluate the primary objective. The objective is to determine the feasibility and usability of the bony bridging score and to investigate the degree of radiological bone ingrowth in patients who are eligible for a lumbar spinal fusion with PLIF (EITŪ) cages.
- Main changes (audit trail)
- RECORD29-nov-2017 - 15-dec-2017


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