Total disc replacement versus fusion in cervical radiculopathy

Not Applicable

Completed

• Conditions: Cervical radiculopathy; Musculoskeletal Diseases; Radiculopathy

• Registration Number: ISRCTN44347115
• Lead Sponsor: DePuy Spine (Sweden)

Brief Summary

2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30641852 results (added 16/01/2019) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33471181/ follow up results (added 22/01/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34920425/ 10-year results (added 20/12/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-19
• Study Completion: 2012-05-31
• Last Update Posted: 4 January 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
eck Disability Index (NDI) at 2 years follow up after intervention

Secondary Outcome Measures

Name	Time	Method
<br> 1. Visual Analaogue Scale (VAS) neck/arm<br> 2. EQ-5D<br> 3. Dysphagia Short Questionnaire (DSQ)<br> 4. Radiographic evaluation<br> 5. Sick leave<br> 6. Consumption of analgetics<br>