The primary objective is to determine the 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.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the radiological bone (in)growth one year after the
cages are placed and will be determined by the use of a CT-scan. The *bony-
bridging score* as developed by SMK radiology will be used.
Secondary outcome
The secondary outcome include the stability of the cages in the intercorporate
space. Movement is determined on a lateral X-ray by using the Vertebral Corner
Assessment (VCA) based on the Distortion Compensated Rontgen Analysis (DCRA)
method. Stability is defined as the absence of micro-movements and migration in
the form of subsidence in the underlying adjacent vertebra. Migration is
defined as the amount of subsidence of the underlying adjacent vertebral cage
(translation (in mm)).
The following parameters are evaluated by using Patient Reported Outcome
Measurements (PROMs):
- Function: Oswestry Disabilty Index (v.2.1a)
- Pain intensity: NRS back (0-10) and NRS leg (0-10)
- Quality of Life: MOS-Short Form-36 (SF-36) and EQ5D-3L
- Satisfaction treatment outcome: NRS (0-10)
In addition, the following clinical parameters are evaluated:
- Complications (number and type) in terms of (Serious) Adverse
(Device-related) Events defined prior to the study.
- Re-operations (number) related to the same problem.
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 cages have a porous architecture similar to the trabecular
bone structure. 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. It seems
that 60% bone ingrowth is possible, however it is unknown whether this outcome
measure is also useful for the PLIF procedure with 3D printed Titanium EIT
cages.
Study objective
The primary objective is to determine the 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 design
This study has been designed as a single center prospective case series.
Study burden and risks
Patients participating in this study will not be exposed to any barred by any
additional risk other than the regular risks for a PLIF procedure. The
surgeries will be performed by an experienced orthopaedic surgeon. The
questionnaires and physical examinations will take some extra time, but do not
bring any extra burden and are part of routine clinical practice. The
additional radiological assessments (1 CT-scan) has a total amount of radiation
of 4 mSv per fusion level. Maximal 2 vertebral segments will be included in the
study, with a maximum radiation of 8 mSv. This is comparable to the radiation a
ski instructor receives during one year of work. A new CT-scanner, the Philips
Ingenuity 128, will be purchased in Q3 2018. The CT-scan for this study is
planned at the 1 year follow-up assessment. With the new CT-scanner the maximum
radiation dose will be reduced to 3 to 4 mSv.
Hengstdal 3
Ubbergen (bij Nijmegen) 6574 NA
NL
Hengstdal 3
Ubbergen (bij Nijmegen) 6574 NA
NL
Listed location countries
Age
Inclusion criteria
Patients with lumbar spondylolisthesis
- Posterior spinal fusion with posterior lumbar interbody fusion (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
- Vertebral body fractures
- Pregnancy
- Severe instabilities
- Demonstrated allergy or foreign body sensitivity to the implant material
- Any medical or surgical condition precluding the potential benefit of spinal surgery
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL64253.091.17 |
| OMON | NL-OMON20071 |