Clinical trial NCT00735176: The Norwegian Cervical Arthroplasty Trial
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radiculopathy, Cervical
Keywords: Radiculopathy, cervical
Nerve Root Compression
Disc, intervertebral
Intervertebral Disk Displacement
Spondylosis
Spinal Osteophytosis
Arthroplasty, replacement
Diskectomy
Spinal Fusion
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Rikshospitalet University Hospital
name: Haukeland University Hospital
name: Ullevaal University Hospital
name: University Hospital of North Norway
name: St. Olavs Hospital
First posted: 2008-08-14
Enrollment: 136
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: change in Neck Disability Index (NDI)
timeFrame: up to 5 years
Secondary outcomes:
measure: Clinical effect, measured by use of EQ5-D, SF-36, numeric arm/neck pain registration, dysphagia score, rate of complications/reoperations/morbidity
timeFrame: Preoperatively. Postoperatively: 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years
measure: Health economical aspects, measuring hospital costs, patient costs, primary health service costs, and performing cost-utility analyses.
timeFrame: Postoperatively: 3 months, 6 months, 1 year, 2 years
measure: Adjacent level disc disease, measured by use of MRI scans.
timeFrame: Maximum 4 months preoperatively. Postoperatively:1 year, 2 years, 5 years
measure: 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)
timeFrame: Preoperatively. Postoperatively: 1 day, 6 weeks, 1 year, 2 years, 5 years
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs Hospital
Study officials:
affiliation: Department of Neurosurgery, St. Olavs Hospital
name: Øystein P Nygaard, Professor MD
role: STUDY_CHAIR
References:
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.
citation: Sundseth J, Fredriksli OA, Kolstad F, Johnsen LG, Pripp AH, Andresen H, Myrseth E, Muller K, Nygaard OP, Zwart JA; NORCAT study group. The Norwegian Cervical Arthroplasty Trial (NORCAT): 2-year clinical outcome after single-level cervical arthroplasty versus fusion-a prospective, single-blinded, randomized, controlled multicenter study. Eur Spine J. 2017 Apr;26(4):1225-1235. doi: 10.1007/s00586-016-4922-5. Epub 2016 Dec 23.
citation: Johansen TO, Sundseth J, Fredriksli OA, Andresen H, Zwart JA, Kolstad F, Pripp AH, Gulati S, Nygaard OP. Effect of Arthroplasty vs Fusion for Patients With Cervical Radiculopathy: A Randomized Clinical Trial. JAMA Netw Open. 2021 Aug 2;4(8):e2119606. doi: 10.1001/jamanetworkopen.2021.19606.