Rheumatoid arthritis, atlantoaxial subluxation without neurological deficits. AADI 5-12 mm
Conditions
Interventions
Surgical treatment: Different surgical opportunities and techniques for cervical fixation exist. The choice of technique depends on the severity of the cervical spine involvement and the surgeon’s pre
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: 1. Rheumatoid Arthritis patients, seropositive; 2. Age 18-70; 3. Ranawat I and II: no neurological impairment; 4. C1-C2 subluxation: AADI: 5-12 mm; 5. C1-C2 subluxation reducible or irreducible; 6. Informed consent.
Exclusion criteria
Exclusion criteria: 1. Ranawat IIIA and IIIB: neurological impairment; 2. Severe comorbidity; 3. Previous craniocervical operations; 4. C1-C2 subluxation: AADI 12 mm or PADI < 10 mm; 5. MRI incompatibility.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the occurrence of a major event: 1. Neurological disability (paraesthesias, worsened Myelopathy Disability Index > 3 points); 2. Radiological progression (signs of myelopathy on MRI, impression of brainstem by vertical translocation, AADI > 12 mm, Vertical translocation); 3. Surgery (B) or resurgery (A) in case of progression to a stadium that longer wait and see will result in inevitable neurological deficit or death; 4. Death (all causes). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures are Ranawat, ASIA, DAS-28, VAS, EuroQol, SF-36, functional X-ray and MRI. The outcome will be evaluated at fixed intervals and a Kaplan Meier Survival Analysis will be performed. | — |
Contacts
Public ContactJ.F.C. Wolfs
Leiden University Medical Center (LUMC) P.O. Box 9600
Outcome results
None listed