Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
30/08/2012
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 JM Webb

ORCID ID

Contact details

Department of Orthopaedic Surgery
North Bristol NHS Trust
Frenchay Hospital
Frenchay Park Road
Bristol
BS16 1LE
United Kingdom
+44 (0)117 950 5050

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0234098041

Study information

Scientific title

Acronym

Study hypothesis

Comparing two different methods of fixing an anterior cruciate ligament (ACL) graft to the tibia in patients undergoing ACL reconstruction. To identify any difference in knee stability, range of movement or return to pre-injury levels of activity between the two groups.

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

Anterior cruciate ligament (ACL) graft

Intervention

Randomised controlled trial. Patients randomised to one of two methods of fixation of ACL grafts.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Post operative knee laxity

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/2001

Overall trial end date

31/05/2003

Reason abandoned

Eligibility

Participant inclusion criteria

80 Patients undergoing ACL reconstruction.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

80

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/06/2001

Recruitment end date

31/05/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Orthopaedic Surgery
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

Publication citations

Additional files

Editorial Notes