Skip to content

Total disc replacement versus fusion in cervical radiculopathy

Total disc replacement versus fusion in cervical radiculopathy: a multicenter randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN44347115
Enrollment
150
Registered
2012-03-19
Start date
2007-05-20
Completion date
Unknown
Last updated
2022-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical radiculopathy Musculoskeletal Diseases Radiculopathy

Interventions

1. Decompression and fusion of 1-2 cervical levels. Fusion is done with bone graft from iliac crest and anterior plate stabilisation 2. Decompression and disc replacement with Discover

Sponsors

DePuy Spine (Sweden)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. At least 3 months of radiculopathy 2. Associated findings on Magnetic resonance imaging (MRI) at 1-2 levels in cervical spine 3. 18-60 years old

Exclusion criteria

Exclusion criteria: 1. Previous cervical surgery 2. Drug abuse or other obvious reason for bad compliance 3. History of Whiplash associated disorder (WAD) or severe cervical trauma 4. Rheumatoid arthritis, known malignancy, active infection or other systemic disease 5. Pregnancy 6. Cervical malformations

Design outcomes

Primary

MeasureTime frame
Neck Disability Index (NDI) at 2 years follow up after intervention

Secondary

MeasureTime frame
1. Visual Analaogue Scale (VAS) neck/arm 2. EQ-5D 3. Dysphagia Short Questionnaire (DSQ) 4. Radiographic evaluation 5. Sick leave 6. Consumption of analgetics

Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026