Investigation into patient characteristics and treatment factors associated with short-term and medium-term outcome following Anterior Cruciate Ligament Reconstruction
| ISRCTN | ISRCTN30554985 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30554985 |
| Secondary identifying numbers | N0209181918 |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 23/05/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Fares S Haddad
Scientific
Scientific
Department of Trauma & Orthopaedics
University College Hospital
235 Euston Road
London
NW1 2BU
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant 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. |
| Scientific title | Investigation into patient characteristics and treatment factors associated with short-term and medium-term outcome following Anterior Cruciate Ligament Reconstruction |
| Study objectives | 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(s) | 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. |
| Health condition(s) or problem(s) studied | Surgery: Anterior cruciate ligament reconstruction |
| Intervention | Randomised between 2 groups: normal management vs measures to reduce swelling |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Questionnaire - International Knee Documentation committee (IKDC) form |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/04/2006 |
| Completion date | 01/03/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 100 |
| Key inclusion criteria | 100 patients recruited from UCLH Foundation Trust, in need of Arthroscopic anterior cruciate ligament reconstruction (ACL) for uncomplicated ACL reconstruction. |
| Key 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). |
| Date of first enrolment | 01/04/2006 |
| Date of final enrolment | 01/03/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Trauma & Orthopaedics
London
NW1 2BU
United Kingdom
NW1 2BU
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
UCL Hospitals NHS Foundation Trust (UK), NHS R&D Support Funding
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
23/05/2016: No publications found, verifying study status with principal investigator
