| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN71676516 |
| Date ISRCTN assigned | 04/12/2006 |
| Local reference number(s) | Z0002 |
| Public title | Randomised controlled trial to compare the functional outcome of the standard NexGen Legacy knee replacement to that of the NexGen Legacy Flex knee replacement which is designed to allow a greater range of flexion in the knee |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Total knee replacement surgery in patients with osteoarthritis |
| Study hypothesis | Does the use of the NexGen Legacy Flex knee replacement produce significantly better outcomes than those obtained with the standard NexGen Legacy knee replacement ? |
| Design/methodology | Prospective, double blind, randomised controlled trial. |
| Research ethics review | The study was approved by the Lothian Research Ethics Committee on 17/2/2004 (ref: LREC2003/1/36). |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Patients with knee osteoarthritis who are on the waiting list to undergo unilateral total knee arthroplasty at the New Royal Infirmary in Edinburgh and who can passively flex their knee 90 degrees or more. |
| Participants - exclusion criteria | 1. Inflammatory polyarthritis
2. Disorders of the feet, hips or spine causing abnormal gait or significant pain
3. Dementia
4. Severe visual impairment
5. Neurological conditions affecting movement
6. Inability to give informed consent |
| Patient information material |
|
| Anticipated start date | 01/03/2004 |
| Anticipated end date | 31/12/2006 |
| Status of trial | Completed |
| Target number of participants | 80, 40 in each group |
| Interventions | Standard NexGen Legacy knee replacement versus the NexGen Legacy Flex knee replacement |
| Primary outcome measure(s) | Functional range of movement of the knee using flexible electrogoniometry |
| Secondary outcome measure(s) | 1. Passive range of motion
2. Pain
3. Knee extensor and flexor strength
4. Walking speed
5. Woman on the Move Against Cancer (WOMAC)
6. Knee Society Score
7. Daily Physical Activity
8. Quality of Life |
| Publications | Results in http://www.ncbi.nlm.nih.gov/pubmed/18160497 |
| Sources of funding | Zimmer UK Ltd (ref: Z0002) |
| Sponsor name | Queen Margaret University College (UK) |
| Sponsor details | Clerwood Terrace
Edinburgh
United Kingdom
EH12 8TS |
| Sponsor telephone | +44 (0)131 3173000 |
| Sponsor email | whardcastle@qmuc.ac.uk |
| Sponsor website | http://www.qmuc.ac.uk |
| Contact name | Dr Marietta van der Linden |
| Contact details | School of Health Sciences
Queen Margaret University College
Duke Street
Edinburgh
United Kingdom
EH6 8HF |
| Contact telephone | +44 (0)131 3173820 |
| Contact email | mvanderlinden@qmuc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN71676516 |
| Date last extracted from ISRCTN register | 17/04/2008 |
