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
Protocol serial number	Z0002
Sponsor	Queen Margaret University College (UK)
Funder	Zimmer UK Ltd (ref: Z0002)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Marietta van der Linden
Scientific

School of Health Sciences
Queen Margaret University College
Duke Street
Edinburgh
EH6 8HF
United Kingdom

Phone	+44 (0)131 3173820
Email	mvanderlinden@qmuc.ac.uk

Primary study design	Interventional
Study design	Prospective, double blind, randomised controlled trial.
Secondary study design	Randomised controlled trial
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(s)	Functional range of movement of the knee using flexible electrogoniometry
Key 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
Completion date	31/12/2006

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	80
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

School of Health Sciences

Edinburgh
EH6 8HF
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/01/2008		Yes	No