Condition category
Musculoskeletal Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
05/06/2014
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 John O'Dowd

ORCID ID

Contact details

Spinal Disorder Unit
University Hospital NHS Trust
D Floor
West Block
Queen's Medical Centre
Nottingham
NG7 2UH
United Kingdom
+44 (0)115 924 9924

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

940139

Study information

Scientific title

Acronym

Study hypothesis

The main objective of this study is to measure the difference in outcome when internal fixation techniques are used to augment the spinal fusion.

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

Not specified

Trial type

Treatment

Patient information sheet

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

Condition

Spinal conditions, lumbosacral joint fixation

Intervention

1. Standard posterior lumbosacral fusion without instrumentation, using corticocancellous autograft from the patient's own iliac crest
2. An identical operation will be performed, with the addition of pedicle screw fixation system

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/02/1995

Overall trial end date

31/01/1998

Reason abandoned

Eligibility

Participant inclusion criteria

200 patients admitted to the Spinal Surgery Unit for L5-S1 and L4-S1 fusion for back pain and one of the following diagnostic groups will be entered into the trial:
1. Discogenic back pain
2. Lumbar spondylolysis
3. Degenerative spondylolisthesis
4. Isthmic spondylolisthesis
5. Segmental instability
6. Degenerative scoliosis
7. Failed decompressive surgery

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

1. Patients who have predominantly root symptoms
2. Patients who have had previous fusion or stabilisation surgery
3. Patients who are aged over 60

Recruitment start date

01/02/1995

Recruitment end date

31/01/1998

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Spinal Disorder Unit
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive Trent (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