NCT00735176

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 14, 2008

Completed
18 days until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

January 11, 2019

Status Verified

January 1, 2019

Enrollment Period

8.9 years

First QC Date

August 13, 2008

Last Update Submit

January 10, 2019

Conditions

Radiculopathy, Cervical

Keywords

Radiculopathy, cervicalNerve Root CompressionDisc, intervertebralIntervertebral Disk DisplacementSpondylosisSpinal OsteophytosisArthroplasty, replacementDiskectomySpinal Fusion

Outcome Measures

Primary Outcomes (1)

  • change in Neck Disability Index (NDI)

    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

    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

Study Arms (2)

Artificial Cervical Disc

EXPERIMENTAL

Anterior cervical discectomy, followed by insertion of the Discover™ Artificial Cervical Disc

Procedure: Cervical arthroplasty

ACDF

ACTIVE COMPARATOR

Anterior cervical discectomy and fusion (ACDF)

Procedure: Anterior cervical discectomy and fusion (ACDF)

Interventions

Cervical arthroplastyPROCEDURE

Anterior cervical discectomy, followed by insertion of the Discover™ Artificial Cervical Disc

Also known as: Discover™ Artificial Cervical Disc
Artificial Cervical Disc
Anterior cervical discectomy and fusion (ACDF)PROCEDURE

Anterior cervical discectomy and decompression, followed by insertion of a PEEK cage, which induces fusion.

Also known as: Cage is made of polyetheretherketone (PEEK)
ACDF

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Olavs Hospital

Trondheim, 7004, Norway

Location

Related Publications (3)

  • 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.

    PMID: 27061727BACKGROUND

  • 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.

    PMID: 28012081RESULT

  • 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.

    PMID: 34351401DERIVED

MeSH Terms

Conditions

RadiculopathyIntervertebral Disc DisplacementSpondylosisSpinal Osteophytosis

Interventions

Gene Fusion

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesSpinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Recombination, GeneticGenetic Phenomena

Study Officials

  • Øystein P Nygaard, Professor MD

    Department of Neurosurgery, St. Olavs Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2008

First Posted

August 14, 2008

Study Start

September 1, 2008

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

January 11, 2019

Record last verified: 2019-01

Locations

NO(1)