Condition category
Nervous System Diseases
Date applied
25/01/2005
Date assigned
19/04/2005
Last edited
15/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Study information

Scientific title

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

Multi-centre

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 measures

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

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

Sponsor information

Organisation

Reumafonds (Dutch Rheumatoid Arthritis Foundation) (The Netherlands)

Sponsor details

Dr Jan van Breemenstraat 4
Amsterdam
1040 KB
Netherlands

Sponsor type

Research organisation

Website

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

Results - basic reporting

Publication summary

Protocol in http://www.ncbi.nlm.nih.gov/pubmed/16483360

Publication citations

  1. 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.

Additional files

Editorial Notes