Functional outcome in two different designs of knee replacements

ISRCTN	ISRCTN05635855
DOI	https://doi.org/10.1186/ISRCTN05635855
Protocol serial number	N/A
Sponsor	Queen Margaret University (UK)
Funder	DePuy International Ltd (UK)

Submission date: 19/05/2008
Registration date: 24/07/2008
Last edited: 09/11/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

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

School of Health Sciences
Queen Margaret University
Queen Margaret University Drive
Musselburgh
EH21 6UU
United Kingdom

Phone	+44 (0)131 4740000
Email	mvanderlinden@qmu.ac.uk

Study information

Primary study design	Interventional
Study design	Prospective, double blind randomised controlled trial, single centre study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	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(s)	Ethics approval received from the Lothian Research Ethics Committee 2 on the 22nd May 2007 (ref: 07/S1102/12).
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	01/09/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	90
Key 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.
Key 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.
Date of first enrolment	01/09/2007
Date of final enrolment	01/09/2009

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centre

School of Health Sciences

Musselburgh
EH21 6UU
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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	01/08/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes