Condition category
Musculoskeletal Diseases
Date applied
19/05/2008
Date assigned
24/07/2008
Last edited
09/11/2012
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
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 measures

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

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

http://www.qmu.ac.uk/

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

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22844045

Publication citations

  1. 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.

Additional files

Editorial Notes