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Table 5 Primary outcome parameters: Events

From: Rationale and design of The Delphi Trial – I(RCT)2: international randomized clinical trial of rheumatoid craniocervical treatment, an intervention-prognostic trial comparing 'early' surgery with conservative treatment [ISRCTN65076841]

Event

 

1. Neurological disability

Worsened MDI > 3 points

Signs of myelopathy (Ranawat IIIA and IIIB)

2. Radiological progression

Signs of myelopathy on MRI

Vertical translocation/Impression brainstem AADI > 12 mm

3. Surgery

Conservative treatment group

- Intolerable pain

4. Resurgery

Surgical group

5. Death

All causes