Contact information
Type
Scientific
Primary contact
Dr Wilco Peul
ORCID ID
Contact details
Albinusdreef 2
Leiden
2300 RC
Netherlands
+31 (0)715263957
w.peul@mchaaglanden.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
DAA 04-1-05; NTR474
Study information
Scientific title
The Delphi Trial I(RCT)2 international randomised clinical trial of rheumatoid craniocervical treatment: an intervention-prognostic trial comparing 'early' surgery with natural history
Acronym
The Delphi I(RCT)2
Study hypothesis
There is no difference between early surgery and prolonged conservative treatment.
The prevalence of rheumatoid arthritis is 0.8 - 1%. The upper cervical spine shows signs of damage in 17 - 86% of patients with rheumatoid arthritis (RA). Once neurological deficits develop prognosis is poor. Surgery is advocated by most international centres in an early stage to prevent neurological deterioration and radiological progression of abnormalities.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Rheumatoid arthritis
Intervention
Early surgery versus prolonged conservative treatment:
1. Surgical treatment (A) Operation technique: C1C2 screw fixation according to Magerl or Harms with or without wiring techniques
2. Prolonged conservative treatment (B): The treatment of rheumatoid arthritis patients is aimed primarily at rapid reduction of disease activity by disease-modifying anti-rheumatic drugs, thus preventing (progression of) damage, including subluxation, and maintenance/restoration of physical (including neurological) function
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
The primary outcome is the occurrence of a major event:
1. Neurological disability
2. Radiological progression
3. Surgery (B) or resurgery (A)
4. Death (all causes)
Secondary outcome measures
1. Ranawat
2. ASIA
3. DAS-28 instrument
4. Visual Analogue Scale (VAS)
5. EuroQol instrument
6. ST-36 instrument
7. Functional X-ray
8. Magnetic resonance imaging (MRI)
Overall trial start date
01/03/2005
Overall trial end date
30/06/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Rheumatoid arthritis patients
2. Aged 18 to 70
3. Ranawat I and II: no neurological impairment
4. C1-C2 subluxation: anterior atlanto-dental interval (AADI) 5 to 12 mm, posterior atlanto-dental interval (PADI) more than 10 mm
5. C1-C2 subluxation may be reducible as well as irreducible
6. Informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
250
Participant exclusion criteria
1. Ranawat IIIA and IIIB: neurological impairment
2. Severe comorbidity
3. Previous craniocervical operations
4. Klippel Feil syndrome
5. C1-C2 subluxation: AADI less than 5 mm or more than 12 mm or PADI less than 10 mm
6. Magnetic resonance imaging (MRI) incompatibility
Recruitment start date
01/03/2005
Recruitment end date
30/06/2007
Locations
Countries of recruitment
Belgium, Canada, Denmark, France, Germany, Italy, Latvia, Netherlands, Portugal, Spain, Sweden, Switzerland, United Kingdom, United States of America
Trial participating centre
Albinusdreef 2
Leiden
2300 RC
Netherlands
Funders
Funder type
Research organisation
Funder name
Reumafonds (Dutch Rheumatoid Arthritis Foundation) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Protocol in http://www.ncbi.nlm.nih.gov/pubmed/16483360
Publication citations
-
Protocol
Wolfs JF, Peul WC, Boers M, van Tulder MW, Brand R, van Houwelingen HJ, Thomeer RT, 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]., BMC Musculoskelet Disord, 2006, 7, 14, doi: 10.1186/1471-2474-7-14.