Treatment of Cervical Radiculopathy With Arthroplasty Compared With Discectomy With Fusion and Cage (ACDF. Clinical, Radiological and Biomechanical Aspects. A Randomized Multicenter Study.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Radiculopathy, Cervical
- Sponsor
- Norwegian University of Science and Technology
- Enrollment
- 136
- Locations
- 1
- Primary Endpoint
- change in Neck Disability Index (NDI)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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).
Investigators
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
Outcomes
Primary Outcomes
change in Neck Disability Index (NDI)
Time Frame: up to 5 years
Secondary Outcomes
- 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)
- 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)
- Adjacent level disc disease, measured by use of MRI scans.(Maximum 4 months preoperatively. Postoperatively:1 year, 2 years, 5 years)
- 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)