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Clinical Trials/ISRCTN44347115
ISRCTN44347115
Completed
未知

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

DePuy Spine (Sweden)0 sites150 target enrollmentMarch 19, 2012

Overview

Phase
未知
Intervention
Not specified
Conditions
Cervical radiculopathy
Sponsor
DePuy Spine (Sweden)
Enrollment
150
Status
Completed
Last Updated
4 years ago

Overview

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)

Registry
who.int
Start Date
March 19, 2012
End Date
May 31, 2012
Last Updated
4 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
DePuy Spine (Sweden)

Eligibility 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

  • 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

Outcomes

Primary Outcomes

Not specified

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