Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
21/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr D R Sandeman

ORCID ID

Contact details

Department of Neurosciences
North Bristol NHS Trust
Frenchay Hospital
Frenchay Park Road
Bristol
BS16 1LE
United Kingdom
+44 (0)117 970 1212
richard.nelson@north-bristol.swest.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0234095390

Study information

Scientific title

Acronym

Study hypothesis

To compare an artificial cervical joint with anterior cervical fusion after a single level discetomy for spondylitic radiculopathy.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Cervical injuries

Intervention

Randomised trial.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Spinal stability.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

19/05/2000

Overall trial end date

01/09/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Patients presenting with cervical injuries.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

19/05/2000

Recruitment end date

01/09/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Neurosciences
Bristol
BS16 1LE
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

North Bristol NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12435973

Publication citations

  1. Results

    Wigfield CC, Gill SS, Nelson RJ, Metcalf NH, Robertson JT, The new Frenchay artificial cervical joint: results from a two-year pilot study., Spine, 2002, 27, 22, 2446-2452, doi: 10.1097/01.BRS.0000032365.21711.5E.

Additional files

Editorial Notes