The Norwegian Cervical Arthroplasty Trial

Radiculopathy, Cervical Clinical Trial

— NORCAT  

Official title:

Treatment of Cervical Radiculopathy With Arthroplasty Compared With Discectomy With Fusion and Cage (ACDF. Clinical, Radiological and Biomechanical Aspects. A Randomized Multicenter Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00735176
• Other study ID #: 4.2008.211 (REK)
• Secondary ID: 18809/2/AMS
• Status: Completed
• Phase: N/A
• Start date: September 2008
• Est. completion date: August 2017

Study information

• Verified date: January 2019
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will compare cervical arthroplasty with cervical discectomy and fusion, in the treatment of cervical radiculopathy. The 0-hypothesis is that there is no difference between the two methods, when comparing primary and secondary outcome variables.

Description:

Anterior discectomy and fusion (ACDF) is in Norway currently the most common operative method against cervical radiculopathy, caused by disc herniation and/or spondylosis. In the last decade cervical arthroplasty has emerged as a new alternative operative method. Arthroplasty is claimed to preserve the natural motion of the spine, thereby preventing adjacent level disc disease and providing better clinical results. However, this hypothesis has not yet been adequately proven. In our study, we will prove if there is any real difference in terms of clinical effect between cervical arthroplasty and ACDF.We will also compare the overall costs of the two methods, including cost-utility analyses. Moreover, we will study the development of adjacent level disease by use of MRI scans, and analyze cervical spine motion and disc height by use of Distortion Compensated Roentgen Analysis (DCRA).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 60 Years

Eligibility

Inclusion Criteria:

• Age 25 - 60 years

• Clinical C6 or C7 root radiculopathy with corresponding radiologic findings with or without neurological symptoms

• Mechanical provoked pain which aggravate with physical activity or positive Spurling test

• Radiological nerve root compression on the basis of disc herniation or spondylosis

• NDI =/> 30 percent

• The patient has not responded to non-operative treatment and shown no sign of improvement during the last 6 weeks

Exclusion Criteria:

• Significant spondylosis involving more than one level

• Intramedullary changes on MRI

• Ankylosis at adjacent level

• Clinical suspicion of myelopathy

• Chronic generalised pain syndrome

• Infection

• Active cancer

• Rheumatoid arthritis involving the cervical spine

• Previous trauma involving the cervical spine

• Pregnancy

• Allergy against contents in cage/artificial disc

• Previous neck surgery

• Psychological or somatic illness that causes the patient not to be suitable for the study

• The patient does not understand Norwegian orally or in writing.

• Abuse of medication/narcotics

Related Conditions & MeSH terms

• Radiculopathy
• Radiculopathy, Cervical

Intervention

Procedure:
• Cervical arthroplasty
Anterior cervical discectomy, followed by insertion of the Discover™ Artificial Cervical Disc
• Anterior cervical discectomy and fusion (ACDF)
Anterior cervical discectomy and decompression, followed by insertion of a PEEK cage, which induces fusion.

Locations

Country	Name	City	State
Norway	St. Olavs Hospital	Trondheim

Sponsors (6)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Haukeland University Hospital, Rikshospitalet University Hospital, St. Olavs Hospital, Ullevaal University Hospital, University Hospital of North Norway

Country where clinical trial is conducted

Norway, 

References & Publications (2)

Sundseth J, Fredriksli OA, Kolstad F, Johnsen LG, Pripp AH, Andresen H, Myrseth E, Müller K, Nygaard ØP, Zwart JA; NORCAT study group. The Norwegian Cervical Arthroplasty Trial (NORCAT): 2-year clinical outcome after single-level cervical arthroplasty ver — View Citation

Sundseth J, Jacobsen EA, Kolstad F, Sletteberg RO, Nygaard OP, Johnsen LG, Pripp AH, Andresen H, Fredriksli OA, Myrseth E, Zwart JA. Heterotopic ossification and clinical outcome in nonconstrained cervical arthroplasty 2 years after surgery: the Norwegian Cervical Arthroplasty Trial (NORCAT). Eur Spine J. 2016 Jul;25(7):2271-8. doi: 10.1007/s00586-016-4549-6. Epub 2016 Apr 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in Neck Disability Index (NDI)		up to 5 years
Secondary	Clinical effect, measured by use of EQ5-D, SF-36, numeric arm/neck pain registration, dysphagia score, rate of complications/reoperations/morbidity		Preoperatively. Postoperatively: 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years
Secondary	Health economical aspects, measuring hospital costs, patient costs, primary health service costs, and performing cost-utility analyses.		Postoperatively: 3 months, 6 months, 1 year, 2 years
Secondary	Adjacent level disc disease, measured by use of MRI scans.		Maximum 4 months preoperatively. Postoperatively:1 year, 2 years, 5 years
Secondary	Preservation of cervical translational and rotational segmental motion, disc height and dorsoventral displacement, by use of functional X-rays with Distortion Compensated Roentgen Analysis (DCRA)		Preoperatively. Postoperatively: 1 day, 6 weeks, 1 year, 2 years, 5 years