Contact information
Type
Scientific
Primary contact
Dr Marietta van der Linden
ORCID ID
Contact details
School of Health Sciences
Queen Margaret University
Queen Margaret University Drive
Musselburgh
EH21 6UU
United Kingdom
+44 (0)131 4740000
mvanderlinden@qmu.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A randomised controlled trial to compare the functional outcome between the PFC Sigma fixed bearing posterior cruciate ligament (PCL) preserving implant with the PFC Sigma posterior stabilised mobile bearing implant
Acronym
Study hypothesis
The aim of this study is to compare the functional outcome of the cruciate substituting PFC Sigma rotating platform flexion (RPF) implant with the cruciate retaining PFC Sigma cruciate retaining (CR) in patients with osteoarthritis.
Ethics approval
Ethics approval received from the Lothian Research Ethics Committee 2 on the 22nd May 2007 (ref: 07/S1102/12).
Study design
Prospective, double blind randomised controlled trial, single centre study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Total knee replacement surgery
Intervention
Two groups of patients will be compared. The only difference in treatment between the two groups will be the use of the PFC Sigma RPF which has a mobile bearing and requires sacrificing of the posterior cruciate ligament and the posterior cruciate ligament retaining PFC Sigma implant which has a fixed bearing.
Follow-up will be one year after surgery when the primary and secondary outcome measures are collected.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Knee excursion during functional activities as measured using electrogoniometry. Primary and secondary outcome measures are collected around one to three weeks before surgery and one year after surgery for both groups.
Secondary outcome measures
1. The passive range of motion of the knee
2. Flexor and extensor strength as measured using a MIE myometer
3. Function as measured by the American Knee Society Score
4. Function, stiffness and pain as measured by the Western Ontario and McMaster Universities (WOMAC) questionnaire
5. Quality of life, using the 36-item short form health survey, version 2 (SF-36 v2)
6. Pain, using the Visual Analogue Score (0 = no pain to 10 = unbearable pain)
7. Walking speed
8. Physical mobility as measured by an activity monitor (activPAL)
9. Canadian Occupational Performance Measure
Primary and secondary outcome measures are collected around one to three weeks before surgery and one year after surgery for both groups.
Overall trial start date
01/09/2007
Overall trial end date
01/09/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Ninety suitable men and women (no age limits) with osteoarthritis undergoing a Total Knee Replacement (TKR) at the New Royal Infirmary, Edinburgh who are able to actively flex the knee more than 90 degrees will be recruited from the waiting list of three orthopaedic surgeons. Suitable patients will be identified from medical records and will be living in the Lothian region. All subjects will be medically fit for testing and have no other lower limb impairments.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
90
Participant exclusion criteria
1. Inflammatory polyarthritis
2. Disorders of the feet, ankles or 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
7. Any other disorders of the contra-lateral knee causing abnormal gait or significant pain. Subjects with radiological evidence of osteoarthritis of the contra-lateral knee will be included provided the patient does not report significant pain or restriction in motion of the contra-lateral knee. Similarly patients with total knee arthroplasty of the contra-lateral knee will be included provided the patient does not report significant pain or restriction in motion of the contra-lateral knee.
Recruitment start date
01/09/2007
Recruitment end date
01/09/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
School of Health Sciences
Musselburgh
EH21 6UU
United Kingdom
Sponsor information
Organisation
Queen Margaret University (UK)
Sponsor details
c/o Professor Marie Donaghy
School of Health Sciences
Queen Margaret University Drive
Musselburgh
EH21 6UU
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
DePuy International Ltd (UK)
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
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22844045
Publication citations
-
Results
Nutton RW, Wade FA, Coutts FJ, van der Linden ML, Does a mobile-bearing, high-flexion design increase knee flexion after total knee replacement?, J Bone Joint Surg Br, 2012, 94, 8, 1051-1057, doi: 10.1302/0301-620X.94B8.28828.