Condition category
Surgery
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
23/05/2016
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 Fares S Haddad

ORCID ID

Contact details

Department of Trauma & Orthopaedics
University College Hospital
235 Euston Road
London
NW1 2BU
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0209181918

Study information

Scientific title

Investigation into patient characteristics and treatment factors associated with short-term and medium-term outcome following Anterior Cruciate Ligament Reconstruction

Acronym

Study hypothesis

What are the factors pre-operatively, intra-operatively and post-operative and related to patient characteristics that have the most influence on outcomes of ACL reconstruction? Particular focus on post operative/rehabilitation factors (knee swelling and initial rehabilitation) and patient psychological factors (adherence to rehabilitation, motivation and sense of control).

Ethics approval

Added 28/08/09:
Joint UCL/UCLH Committees on the Ethics of Human Research (Committee A), Research & Development Directorate, 1st Floor Maple House, 149 Tottenham Court Road, London W1P 9LL. REC reference number: 05/Q0505/120. Meeting date 26th January 2006, approval letter dated 9th February 2006.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Please contact Bruce.Paton@uclh.nhs.uk or Bruce Paton, Extended Scope Practitioner, Physiotherapy Dept., University College Hospital, 235 Euston Road, London NW1 2BU.

Condition

Surgery: Anterior cruciate ligament reconstruction

Intervention

Randomised between 2 groups: normal management vs measures to reduce swelling

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Questionnaire - International Knee Documentation committee (IKDC) form

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/2006

Overall trial end date

01/03/2010

Reason abandoned

Eligibility

Participant inclusion criteria

100 patients recruited from UCLH Foundation Trust, in need of Arthroscopic anterior cruciate ligament reconstruction (ACL) for uncomplicated ACL reconstruction.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

100

Participant exclusion criteria

1. Concurrent surgery (meniscus repair, posterior cruciate ligament reconstruction, other ligament injuries)
2. Patients with gross pre-operative swelling/inflammation, pre-operative loss of normal movement (esp. leg straightening), heavy manual/impact type of work, compulsory return to work before 4 weeks post op).

Recruitment start date

01/04/2006

Recruitment end date

01/03/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Trauma & Orthopaedics
London
NW1 2BU
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2007 Update - Department of Health

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.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

UCL Hospitals NHS Foundation Trust (UK), NHS R&D Support Funding

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

23/05/2016: No publications found, verifying study status with principal investigator