Radiculopathy, CervicalNORCATNCT00735176
The Norwegian Cervical Arthroplasty Trial
A study testing Cervical arthroplasty and Anterior cervical discectomy and fusion (ACDF) in people with Radiculopathy, Cervical, run by Norwegian University of Science and Technology at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Radiculopathy, Cervical
- What is being tested?
- Cervical arthroplasty and Anterior cervical discectomy and fusion (ACDF)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2008to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Significant spondylosis involving more than one level
- Intramedullary changes on MRI
- Ankylosis at adjacent level
- Clinical suspicion of myelopathy
- Chronic generalised pain syndrome
- Infection
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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).
- Conditions
- Radiculopathy, Cervical
- Being tested
- Cervical arthroplasty, Anterior cervical discectomy and fusion (ACDF)
- Keywords
- Radiculopathy, cervical, Nerve Root Compression, Disc, intervertebral, Intervertebral Disk Displacement, Spondylosis, Spinal Osteophytosis, Arthroplasty, replacement, Diskectomy, Spinal Fusion
- Medical subject headings
- Radiculopathy, Intervertebral Disc Displacement, Spondylosis, Spinal Osteophytosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical arthroplastyProcedure or surgery
Also called Discover™ Artificial Cervical Disc
Anterior cervical discectomy, followed by insertion of the Discover™ Artificial Cervical Disc
Anterior cervical discectomy and fusion (ACDF)Procedure or surgery
Also called Cage is made of polyetheretherketone (PEEK)
Anterior cervical discectomy and decompression, followed by insertion of a PEEK cage, which induces fusion.
| Study group | Role | What they receive |
|---|---|---|
| Artificial Cervical Disc | Experimental | Anterior cervical discectomy, followed by insertion of the Discover™ Artificial Cervical Disc Receives: Procedure: Cervical arthroplasty |
| ACDF | Active comparator | Anterior cervical discectomy and fusion (ACDF) Receives: Procedure: Anterior cervical discectomy and fusion (ACDF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Neck Disability Index (NDI)
Measured: up to 5 years
Secondary outcomes (4)
Clinical effect, measured by use of EQ5-D, SF-36, numeric arm/neck pain registration, dysphagia score, rate of complications/reoperations/morbidity
Measured: 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.
Measured: Postoperatively: 3 months, 6 months, 1 year, 2 years
Adjacent level disc disease, measured by use of MRI scans.
Measured: 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)
Measured: Preoperatively. Postoperatively: 1 day, 6 weeks, 1 year, 2 years, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2008 (estimated)
- Study startSep 2008
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Radiculopathy, CervicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Rikshospitalet University Hospital, Haukeland University Hospital, Ullevaal University Hospital, University Hospital of North Norway, St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Øystein P Nygaard, Professor MD, Study chair, Department of Neurosurgery, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00735176
- Sponsor's protocol ID
- 4.2008.211 (REK)
- Other IDs
- 18809/2/AMS
- Acronym
- NORCAT
- Status last verified
- Jan 2019
- First submitted
- 13 Aug 2008
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27061727Sundseth 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.
PubMed 28012081Johansen 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.
PubMed 34351401
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00735176
- Acronym / sponsor ID
- NORCAT / 4.2008.211 (REK)
- Conditions
- Radiculopathy, Cervical
- Keywords
- Radiculopathy, cervical, Nerve Root Compression, Disc, intervertebral, Intervertebral Disk Displacement, Spondylosis, Spinal Osteophytosis, Arthroplasty, replacement, Diskectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Rikshospitalet University Hospital, Haukeland University Hospital, Ullevaal University Hospital, University Hospital of North Norway, St. Olavs Hospital
- Study start
- Sep 2008 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 14 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Artificial Cervical Disc | Experimental | Procedure: Cervical arthroplastyAnterior cervical discectomy, followed by insertion of the Discover™ Artificial Cervical Disc |
| ACDF | Active comparator | Procedure: Anterior cervical discectomy and fusion (ACDF)Anterior cervical discectomy and fusion (ACDF) |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- Significant spondylosis involving more than one level
- Intramedullary changes on MRI
- Ankylosis at adjacent level
- Clinical suspicion of myelopathy
- Chronic generalised pain syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervical arthroplastyAlso: Discover™ Artificial Cervical DiscAnterior cervical discectomy, followed by insertion of the Discover™ Artificial Cervical Disc | Procedure or surgery | Artificial Cervical Disc |
| Anterior cervical discectomy and fusion (ACDF)Also: Cage is made of polyetheretherketone (PEEK)Anterior cervical discectomy and decompression, followed by insertion of a PEEK cage, which induces fusion. | Procedure or surgery | ACDF |
Primary outcome
change in Neck Disability Index (NDI)
Time frame: up to 5 years
4 secondary outcomes
Clinical effect, measured by use of EQ5-D, SF-36, numeric arm/neck pain registration, dysphagia score, rate of complications/reoperations/morbidity
Time frame: 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.
Time frame: Postoperatively: 3 months, 6 months, 1 year, 2 years
Adjacent level disc disease, measured by use of MRI scans.
Time frame: 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)
Time frame: Preoperatively. Postoperatively: 1 day, 6 weeks, 1 year, 2 years, 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
- Background: PubMed 27061727Sundseth 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.
- Results publication: PubMed 28012081Sundseth 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.
- Derived from this study: PubMed 34351401Johansen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Øystein P Nygaard, Professor MD study chair
Department of Neurosurgery, St. Olavs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical arthroplasty and Anterior cervical discectomy and fusion (ACDF) in people with Radiculopathy, Cervical, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in Neck Disability Index (NDI) (time frame: up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00735176, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2019.