Chronic low back pain attributable to degenerative facet joints Musculoskeletal Diseases Low back pain
Conditions
Interventions
Thirty consecutive patients presenting at the investigators’ clinics with non-specific CLBP attributable to facet joint degeneration will be selected for FENIX implantation. After having obtained the
Sponsors
AZ Nikolaas
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject has a history of non-specific chronic low back pain (CLBP) for more than 6 months suggestive for “facet joint syndrome” (See clinical diagnosis in Attachment 1) 2. Subject age is between 20 and 70 years and is skeletally mature 3. Failed conservative treatment for 3 months, including rehabilitation treatment, pharmacological and minimal interventional treatment. 4. Positive diagnostic nerve block (See Section 10.3) 5. Condition involves at least one lumbar spine level between contiguous levels L1 to S1. 6. Back pain intensity of at least 5 on a scale of 10 (VAS). 7. Oswestry score > 40 (based on 100-point scale) 8. Pain frequency of at least 3 on a 5-point scale 9. Radiology features suggestive for facet joint pathology. (See Section 10.2 for definitions) That is, the patient must have radiographic evidence of facet joint degeneration on Magnetic Resonance Imaging, classified as 1 or 2 on the Weishaupt scale and the SPECT-CT must show a hotspot level 2 at the facet joint, suspected to be the cause of low back pain
Exclusion criteria
Exclusion criteria: 1. Subject has any isthmic spondylolisthesis or degenerative spondylolisthesis >3mm detected on plain X-rays 2. Subject has had prior spine surgery at the index level 3. Subject has disc herniation that is not contained (3 or 4 on the Milette scale) 4. Subject has central spinal canal stenosis 5. Subject has Cauda Equina Syndrome 6. Subject’s facet joints are absent or fractured. 7. Subject is morbidly obese, having a Body Mass Index (BMI) of 35 or greater 8. Kidney disease (serum creatinine >235 µmol) 9. Subject has an active systemic infection or at the operative site 10. Subject has a spinal tumor 11. Subject has a known Chrome-Cobalt allergy. 12. Subject is pregnant or plans to become pregnant during the study 13. Subject is at high risk for evolution to chronicity (StarT back screening tool)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain measured by VAS and functionality measured by the Oswestry Disability Index and radiological stability | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical examination consisting of: paravertebral tenderness, pain radiation pattern, absence of exacerbation with coughing, relief with recumbency, pain not worsened by forward flexion or rising from forward flexion, and pain not exacerbated by hyperextension or extension-rotation. The neurological examination should exclude radicular pain (weakness in the legs, positive Lasègue test). This is only done at intake 2. Patient’s assessment of the pain intensity using a 10-cm visual analogue scale at intake, 12, 26, 52 and 104 weeks 3. Pain frequency measured with a 5-point Likert scale (1 continuously pain, 2 pain most of the time, 3 regularly pain, 4 seldom pain, 5 no pain or only flare-up) at intake, 12, 26, 52 and 104 weeks 4. Functionality measured using the Oswestry Disability Questionnaire at intake, 12, 26, 52 and 104 weeks 5. The consumption of analgesic medication recorded at each visit, analysis will be done according to the Medication Quantification Scale at intake, 12, 26, 52 and 104 weeks 6. Radiographic examination using MRI and SPECT-CT at baseline 7. Flexion extension X-rays and AP and lateral X-rays performed at intake and at 26, 52 and 104 weeks 8. Side effects and complications noted during and post-surgery. These parameters are normally included in the patients’ file and are also included in the study record card. These involve blood loss, potentially infections. 9. Surgical parameters (duration of the surgery, blood loss, need for additional blood administration, type and size of the implant) noted immediately after surgery 10. Duration of incapacity to work. The patient is questioned regarding his work status at intake. If in incapacity to work the duration of this incapacity is questioned. At each of the follow-up visits 12, 26, 52 and 104 weeks the work status is controlled and the duration of incapacity to work is noted. 11. Patient social activities. The patient is questioned about social activities at intake and 12, 26, 52 and 104 week | — |
Countries
Belgium
Outcome results
None listed