The Delphi Trial I(RCT)2 international randomised clinical trial of rheumatoid craniocervical treatment: an intervention-prognostic trial comparing 'early' surgery with natural history
| ISRCTN | ISRCTN65076841 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65076841 |
| Secondary identifying numbers | DAA 04-1-05; NTR474 |
- Submission date
- 25/01/2005
- Registration date
- 19/04/2005
- Last edited
- 03/10/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Wilco Peul
Scientific
Scientific
Albinusdreef 2
Leiden
2300 RC
Netherlands
| Phone | +31 (0)715263957 |
|---|---|
| w.peul@mchaaglanden.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Study acronym | The Delphi I(RCT)2 |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/03/2005 |
| Completion date | 30/06/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 250 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/03/2005 |
| Date of final enrolment | 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
Study participating centre
Albinusdreef 2
Leiden
2300 RC
Netherlands
2300 RC
Netherlands
Sponsor information
Reumafonds (Dutch Rheumatoid Arthritis Foundation) (The Netherlands)
Research organisation
Research organisation
Dr Jan van Breemenstraat 4
Amsterdam
1040 KB
Netherlands
"ROR" |
https://ror.org/05dr3r825 |
|---|
Funders
Funder type
Research organisation
Reumafonds (Dutch Rheumatoid Arthritis Foundation) (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | Protocol | 16/02/2006 | Yes | No |
Editorial Notes
03/10/2018: No publications found, verifying study status with principal investigator.
