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ID
Source
Brief title
Health condition
Patients with lumbar spondylosis requiring a posterior spinal fusion with PLIF procedure.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Bone ingroth in cages assessed on CT with bony bridging score
Secondary outcome
Functional status, quality of life, pain intenstity in beack and leg, satisfaction
Adverse evants: e.g. complications, re-operation
Background summary
A 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 EIT®. 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 EIT® 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 (EIT®) cages.
Study objective
The 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 (EIT®) cages.
Study design
preoprative, 3 months and 1 year
Primary outcome is only assessed at1 year follow up.
Intervention
Posterolateral interbody fusion surgery
Miranda van Hooff
Postbus 9011
Nijmegen 6500 GM
The Netherlands
024 365 9912
m.vanhooff@maartenskliniek.nl
Miranda van Hooff
Postbus 9011
Nijmegen 6500 GM
The Netherlands
024 365 9912
m.vanhooff@maartenskliniek.nl
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
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6700 |
| NTR-old | NTR6870 |
| CCMO | NL64253.091.17 |
| OMON | NL-OMON46506 |