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
| ISRCTN | ISRCTN71676516 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71676516 |
| Secondary identifying numbers | Z0002 |
- Submission date
- 13/10/2006
- Registration date
- 04/12/2006
- Last edited
- 27/06/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Marietta van der Linden
Scientific
Scientific
School of Health Sciences
Queen Margaret University College
Duke Street
Edinburgh
EH6 8HF
United Kingdom
| Phone | +44 (0)131 3173820 |
|---|---|
| mvanderlinden@qmuc.ac.uk |
Study information
| Study design | Prospective, double blind, randomised controlled trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Does the use of the NexGen Legacy Flex knee replacement produce significantly better outcomes than those obtained with the standard NexGen Legacy knee replacement ? |
| Ethics approval(s) | The study was approved by the Lothian Research Ethics Committee on 17/2/2004 (ref: LREC2003/1/36). |
| Health condition(s) or problem(s) studied | Total knee replacement surgery in patients with osteoarthritis |
| Intervention | Standard NexGen Legacy knee replacement versus the NexGen Legacy Flex knee replacement |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Functional range of movement of the knee using flexible electrogoniometry |
| Secondary outcome measures | 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 |
| Overall study start date | 01/03/2004 |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 80, 40 in each group |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/03/2004 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
School of Health Sciences
Edinburgh
EH6 8HF
United Kingdom
EH6 8HF
United Kingdom
Sponsor information
Queen Margaret University College (UK)
University/education
University/education
Clerwood Terrace
Edinburgh
EH12 8TS
Scotland
United Kingdom
| Phone | +44 (0)131 3173000 |
|---|---|
| whardcastle@qmuc.ac.uk | |
| Website | http://www.qmuc.ac.uk |
"ROR" |
https://ror.org/002g3cb31 |
Funders
Funder type
Industry
Zimmer UK Ltd (ref: Z0002)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/01/2008 | Yes | No |
