Contact information
Type
Scientific
Primary contact
Dr Marietta van der Linden
ORCID ID
Contact details
School of Health Sciences
Queen Margaret University College
Duke Street
Edinburgh
EH6 8HF
United Kingdom
+44 (0)131 3173820
mvanderlinden@qmuc.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Z0002
Study information
Scientific title
Acronym
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 ?
Ethics approval
The study was approved by the Lothian Research Ethics Committee on 17/2/2004 (ref: LREC2003/1/36).
Study design
Prospective, double blind, randomised controlled trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/03/2004
Overall trial end date
31/12/2006
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
80, 40 in each group
Participant 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
Recruitment start date
01/03/2004
Recruitment end date
31/12/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
School of Health Sciences
Edinburgh
EH6 8HF
United Kingdom
Sponsor information
Organisation
Queen Margaret University College (UK)
Sponsor details
Clerwood Terrace
Edinburgh
EH12 8TS
United Kingdom
+44 (0)131 3173000
whardcastle@qmuc.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Zimmer UK Ltd (ref: Z0002)
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
Basic results (scientific)
Publication list
Results in http://www.ncbi.nlm.nih.gov/pubmed/18160497
Publication citations
-
Results
Nutton RW, van der Linden ML, Rowe PJ, Gaston P, Wade FA, A prospective randomised double-blind study of functional outcome and range of flexion following total knee replacement with the NexGen standard and high flexion components., J Bone Joint Surg Br, 2008, 90, 1, 37-42, doi: 10.1302/0301-620X.90B1.19702.