The Fixed Bearing Lateral Stabilised DJO 3D Knee™ versus the Finsbury Media... | Not Recruiting
The Fixed Bearing Lateral Stabilise... | Not Recruiting
The Fixed Bearing Lateral Stabilised DJO 3D Knee™ versus the Finsbury Medial Rotation Knee™ System versus the Stryker Triathlon® knee in primary total knee replacement for osteoarthritis and rheumatoid arthritis

Trial Source

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Medical Conditions
  • Osteoarthritis or rheumatoid arthritis affecting the knee
Prof Fares Haddad
See all trial contact details
Primary Contact Details
Not Recruiting
Recruitment Status
ISRCTN60834248
Primary Trial ID Number

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Summary
Background and study aims
Arthritis is a common condition that causes pain and inflammation in the joints. The two most common types of arthritis are rheumatoid arthritis (RA) and osteoarthritis (OA). Osteoarthritis (OA) is the most common type, affecting millions of people worldwide. It occurs when the protective cartilage on the end of bones wears away. The bones then rub against one another, which can cause stiffness, pain, and a reduction in the range of movement. Rheumatoid arthritis (RA) is a disease of the immune system, known as an autoimmune disease. This happens when the cells in the immune system do not behave as they should do, and start to attack healthy joints. In both OA and RA, the most common joint to be affected is the knee. In severe cases, surgery may be the only treatment that can provide patients with relief. A total knee arthroplasty (TKA), also known as a total knee replacement, is recommended if the pain in the knee is so severe that it is causing disability. In the operation, diseased cartilage and bone is removed from the surface of the knee joint and replaced with a man-made surface of metal or plastic (prosthesis). The “new” joint is more stable and helps a person to recover their range of motion (ROM), the amount that the joint can be bent (flexion) and straightened (extension). The most successful operations are able to give patients a greater ROM, and the design of the prosthesis may play an important part in this. The aim of this study is to find out whether newer, more flexible designs of prosthesis are able to give people a better ROM than traditional designs of prosthesis.

Who can participate?
Adults who are having a total knee replacement due to osteoarthritis or rheumatoid arthritis.

What does the study involve?
Participants are randomly allocated into three groups, each of which receiving a different design of knee prosthesis: the Lateral Stabilised 3D Knee™, the Medial Rotation Knee™ or the Triathlon® Knee. Six weeks after the operation, participants complete a ROM test, designed to find out the degree of flexion and extension of the knee joint. This test is repeated six months, one year and two years after the operation.

What are the possible benefits and risks of participating?
Not provided at time of registration.

Where is the study run from?
Orthopaedics and Trauma, University College London Hospitals (UK)

When is the study starting and how long is it expected to run for?
August 2011 to July 2014

Who is funding the study?
DJO Surgical (USA)

Who is the main contact?
Professor Fares Haddad
Research Details
  • The null hypothesis is that there is no difference in range of motion (ROM) at six months post operative, between the three different designs of prosthesis.

    On the basis of the 3D knee prosthesis design, primary study hypotheses are:
    1. Greater range of motion through posterior femoral roll back and maximum posterior condyler offset
    2. Intrinsic stability will achieve functional strength comparable to other intrinsically stable designs

    The secondary study hypothesis is:
    Greater patient satisfaction as a result of the above
Phase
Not Applicable
Study Design
Single centre prospective partially blinded randomised controlled parallel three group trial
Study Type
Interventional
Intervention

The study is a partially blinded, randomised controlled trial of the three knee implants. Adult patients requiring a primary knee replacement for osteoarthritis or rheumatoid arthritis will be randomised to one of the implants.

Intervention Type
Other
Primary Outcome Measures
    1. Knee range of motion measured in degrees, at six months post-operative
    2. The study has been powered to detect a difference of 10 degrees between any two implants
    3. The primary outcome will be analysed by linear regression with study group as the explanatory variable
Secondary Outcome Measures
    1. Validated Health Related Quality of Life measures
    1.1. American Knee Society Score
    1.2. Oxford Knee Score
    1.3. Western Ontario and McMasters University Osteoarthitis (WOMAC)
    1.4. SF-36 Health Survey
    1.5. UCLH functional score
    2. Radiological analysis
    3. Survivorship information
    4. Complication rates
    5. Knee ROM
    Measured at six months post-operative
Publication(s)
Sorry, this information is not available
Result Reports
Sorry, this information is not available
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
Adult
Who Can Participate
Patient
Number of Participants
90
Participant Inclusion Criteria
    1. The patient and surgeon must agree that total knee replacement (TKR) is necessary
    2. The patient must be fit for TKR in the opinion of the Investigator
    3. The patient must be 18 years of age or older at the time of recruitment
    4. The inclusion of minors would introduce an extremely rare subset of TKR patients in which the surgeon’s choice of implant is desirable
    5. The patient must be able to fully understand the study and must therefore be fluent in English. If they are not fluent in English, a translator will be used
    6. The patient must be a permanent resident in an area accessible to the study site
    7. The indication for TKR must be osteoarthritis or rheumatoid arthritis
    8. This must be the patient’s first TKR
Participant Exclusion Criteria
    1. Patient has clinical contra-indications for use of the 3D, MRK or Triathlon Knee systems in the opinion of the Investigator
    2. Underlying neuromuscular/neurovascular problems
    3. The patient already has a TKR on the contralateral side
    4. Patient lacks the capacity to consent, is unwilling or unable to sign the consent form
    5. Patient aged <18 years at time of consenting to study
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
London
NW1 2PG
Trial Contact(s)
Primary Trial Contact
Prof Fares Haddad
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
A prospective randomised controlled study of the Fixed Bearing Lateral Stabilised DJO 3D Knee™ versus the Finsbury Medial Rotation Knee™ System versus the Stryker Triathlon® knee in primary total knee replacement for osteoarthritis and rheumatoid arthritis
EudraCT Number
Sorry, this information is not available
Funder(s)
  • DJO Surgical (USA)
Other Study ID Numbers
1.5
Sponsor(s)
Joint UCL/UCLH/Royal Free Biomedical Research Unit (UK)
Key Dates

Recruitment Start Date

01 Aug 2011

Recruitment End Date

31 Jul 2014

Trial Start Date

01 Aug 2011

Trial End Date

31 Jul 2014

Date added to source

01 Aug 2011

Date updated in source

11 Sep 2015