To document whether patients treated with minimally invasive surgery experience less back pain at 2 and 6 weeks after surgery, compared to patients treated with conventional open instrumented surgery.
ID
Source
Brief title
Condition
- Bone disorders (excl congenital and fractures)
- Spinal cord and nerve root disorders
- Nervous system, skull and spine therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Score on the Visual Analoge Scale (VAS) for low back pain (ranging from 0 - 100
mm) at 2 and 6 weeks after surgery.
Secondary outcome
Oswestry Disability Index (ODI), Roland Morris Disability Questionnaire for
Sciatica (RMDQ), self perceived recovery according to the patient (Likert), VAS
leg pain, quality of life (EQ-5D), re-surgery, complications, and fusion
(evaluated on CT).
Background summary
Spondylolisthesis is a relatively frequent pathology of the spine, in which
patients usually present with radicular leg pain, with or without low back
pain. Whenever the complaints are persistent and invalidating, patients will be
offered surgery. The most common procedure is the conventional instrumented
surgery with bilateral muscle dissection, decompression of the nerve roots, and
correction of the spondylolsthesis with pedicle screw fixation and
intercorporal fusion with cages. The last decade, minimally invasive surgery is
popularized whereby percutaneous pedicle screws are placed and the nerve roots
are decompressed through a small median incision. The rationale of minimally
invasive surgery is less muscle damage, reduced postoperative low back pain,
and faster recovery. However, until now no randomized controlled trial has been
performed on patients with spondylolisthesis, in which minimally invasive
fusion is compared with conventional open surgery.
Study objective
To document whether patients treated with minimally invasive surgery experience
less back pain at 2 and 6 weeks after surgery, compared to patients treated
with conventional open instrumented surgery.
Study design
Prospective randomized controlled trial.
Intervention
Minimally invasive spondylodesis versus conventional open spondylodesis.
Study burden and risks
Patients will frequently fill out questionnaires, have multiple outpatient
visits with radiographic examinations, but there are no disadvantages, risks,
or side-effects related to participation in the trial.
Lijnbaan 32
Den Haag 2512 VA
NL
Lijnbaan 32
Den Haag 2512 VA
NL
Listed location countries
Age
Inclusion criteria
* Age between 18 and 75 years.
* Neurogenic claudication or radicular leg pain with or without low back pain.
* Degenerative or spondylolytic spondylolisthesis grade I or II with spinal
stenosis.
* Persistent complaints for at least 3 months, regardless conservative
treatments.
* Be able to understand the Dutch language and comprehend the questionnaires
and patient information.
* Written informed consent given.
Exclusion criteria
* Previous spine fusion surgery at the same level.
* More than 1 symptomatic level that need fusion.
* Osteoporosis.
* Active infection or prior infection at the surgical site.
* Active cancer.
* Contraindication for surgery.
* Severe mental or psychiatric disorder.
* Alcoholism.
* Morbid obesity (BMI > 40).
* Pregnancy.
* Inadequate knowledge of Dutch language.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT |
| CCMO | NL49044.098.14 |