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 | 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

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Osteoarthritis or rheumatoid arthritis affecting the knee
Prof Fares Haddad
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Primary Contact Details
Not Recruiting
Recruitment Status
Primary Trial ID Number
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
Not Applicable
Study Design
Single centre prospective partially blinded randomised controlled parallel three group trial
Study Type

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
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
Sorry, this information is not available
Result Reports
Sorry, this information is not available
Age Range
Who Can Participate
Number of Participants
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
Trial Location(s)
Trial Contact(s)
Primary Trial Contact
Prof Fares Haddad
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
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
  • DJO Surgical (USA)
Other Study ID Numbers
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 Assigned

01 Aug 2011

Last Updated

11 Sep 2015