Condition category
Musculoskeletal Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
02/02/2015
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 Adrian TH Casey

ORCID ID

Contact details

Neuro-Urology Department
Spinal Injuries Unit
Royal National Orthopaedic Hospital NHS Trust
Brockley Hill
Stanmore
HA7 4LP
United Kingdom
+44 (0)20 8908 5720
athcasey@doctors.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0209121271

Study information

Scientific title

Cervical disc replacement versus inter-body cage for the treatment of spondylotic disease: a randomised, prospective double-blind clinical trial

Acronym

Study hypothesis

Is the Bryan disc a better alternative than traditional discectomy and fusion for the treatment of cervical spondylotic disease?

Ethics approval

Not provided at time of registration

Study design

Randomised prospective double-blind clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Musculoskeletal Diseases: Spondylotic disease

Intervention

Surgery, followed by clinical outcome measures and quality of life score.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

SF-36, Neck disease Index, Myelopathy Disability Index, Visual Analogue Scale.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/2003

Overall trial end date

01/06/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Patients having cervical discectomy and insertion of cervical disc replacement.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/06/2003

Recruitment end date

01/06/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal National Orthopaedic Hospital NHS Trust
Stanmore
HA7 4LP
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

Government

Funder name

Royal National Orthopaedic Hospital 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

Publication citations

Additional files

Editorial Notes