Treatment of Cervical Radiculopathy With Arthroplasty Compared With Discectomy With Fusion and Cage (ACDF) - Full Text View

Sponsors and Collaborators:	Norwegian University of Science and Technology Rikshospitalet University Hospital Haukeland University Hospital Ullevaal University Hospital University Hospital of North Norway St. Olavs Hospital
Information provided by:	Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT00735176

Purpose

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.

Condition	Intervention	Phase
Radiculopathy, Cervical	Procedure: Cervical arthroplasty Procedure: Anterior cervical discectomy and fusion (ACDF)	Phase II

Study Type:

Interventional

Study Design:

Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy 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.

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:

Clinical effect, measured by use of the Neck Disability Index (NDI) [ Time Frame: Preoperatively. Postoperatively: 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
Adjacent level disc disease, measured by use of MRI scans. [ Time Frame: Maximum 4 months preoperatively. Postoperatively:1 year, 2 years, 5 years ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	146
Study Start Date:	September 2008
Estimated Study Completion Date:	September 2018
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Anterior cervical discectomy, followed by insertion of the Discover™ Artificial Cervical Disc	Procedure: Cervical arthroplasty Anterior cervical discectomy, followed by insertion of the Discover™ Artificial Cervical Disc
B: Active Comparator Anterior cervical discectomy and fusion (ACDF)	Procedure: Anterior cervical discectomy and fusion (ACDF) Anterior cervical discectomy and decompression, followed by insertion of a PEEK cage, which induces fusion.

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

Ages Eligible for Study:	25 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 points
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00735176

Contacts

Contact: Hege Andresen, Secretary	0047-73866536	Hege.Andresen@stolav.no
Contact: Øystein P Nygaard, Professor MD	0047-72575246	oystein.nygaard@ntnu.no

Locations

Norway
St. Olavs Hospital	Recruiting
Trondheim, Norway, 7004
Contact: Hege Andresen, Secretary 0047-73866536 Hege.Andresen@stolav.no
Contact: Oystein P Nygaard, Professor MD 0047-72575246 oystein.nygaard@ntnu.no
Principal Investigator: Oystein P Nygaard, Professor MD

Sponsors and Collaborators

Norwegian University of Science and Technology

Rikshospitalet University Hospital

Haukeland University Hospital

Ullevaal University Hospital

University Hospital of North Norway

St. Olavs Hospital

Investigators

Study Chair:	Øystein P Nygaard, Professor MD	Department of Neurosurgery, St. Olavs Hospital. The National Centre for Spinal Diseases.
Principal Investigator:	Andreas Bliksås, Cand.Med.	Department of Neurosurgery, St. Olavs Hospital
Principal Investigator:	Jarle Sundseth, Cand.Med.	Department of Neurosurgery, Rikshospitalet University Hospital

More Information

No publications provided

Responsible Party:	The National Centre for Spinal Diseases ( The National Centre for Spinal Diseases )
Study ID Numbers:	4.2008.211 (REK), 18809/2/AMS(NSD)
Study First Received:	August 13, 2008
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00735176 History of Changes
Health Authority:	Norway: The National Committees for Research Ethics in Norway; Norway: Norwegian Social Science Data Services; Norway: Directorate for Health and Social Affairs

Keywords provided by Norwegian University of Science and Technology:

Radiculopathy, cervical
Nerve Root Compression
Disc, intervertebral
Intervertebral Disk Displacement
Spondylosis

Spinal Osteophytosis
Arthroplasty, replacement
Diskectomy
Spinal Fusion

Study placed in the following topic categories:

Neuromuscular Diseases
Peripheral Nervous System Diseases
Radiculopathy
Intervertebral Disk Displacement

Additional relevant MeSH terms:

Neuromuscular Diseases
Peripheral Nervous System Diseases
Nervous System Diseases
Radiculopathy

ClinicalTrials.gov processed this record on September 04, 2009