Condition category
Surgery
Date applied
13/10/2006
Date assigned
04/12/2006
Last edited
27/06/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.qmuc.ac.uk

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

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/18160497

Publication citations

  1. 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.

Additional files

Editorial Notes