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| ID | Type | Description | Link |
|---|---|---|---|
| 18809/2/AMS | Other Identifier | NSD |
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| Name | Class |
|---|---|
| Rikshospitalet University Hospital | OTHER |
| Haukeland University Hospital | OTHER |
| Ullevaal University Hospital | OTHER |
| University Hospital of North Norway |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Artificial Cervical Disc | Experimental | Anterior cervical discectomy, followed by insertion of the Discoverâ„¢ Artificial Cervical Disc |
|
| ACDF | Active Comparator | Anterior cervical discectomy and fusion (ACDF) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cervical arthroplasty | Procedure | Anterior cervical discectomy, followed by insertion of the Discoverâ„¢ Artificial Cervical Disc |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in Neck Disability Index (NDI) | up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Øystein P Nygaard, Professor MD | Department of Neurosurgery, St. Olavs Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Olavs Hospital | Trondheim | 7004 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27061727 | Background | 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. | |
| 28012081 |
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| ID | Term |
|---|---|
| D011843 | Radiculopathy |
| D007405 | Intervertebral Disc Displacement |
| D055009 | Spondylosis |
| D013128 | Spinal Osteophytosis |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D013122 | Spinal Diseases |
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| ID | Term |
|---|---|
| D050939 | Gene Fusion |
| ID | Term |
|---|---|
| D011995 | Recombination, Genetic |
| D055614 | Genetic Phenomena |
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| OTHER |
| St. Olavs Hospital | OTHER |
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| Anterior cervical discectomy and fusion (ACDF) | Procedure | Anterior cervical discectomy and decompression, followed by insertion of a PEEK cage, which induces fusion. |
|
|
| 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 |
| Result |
| 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. |
| 34351401 | Derived | 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. |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |