Condition category
Musculoskeletal Diseases
Date applied
30/06/2011
Date assigned
01/08/2011
Last edited
11/09/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English 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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Fares Haddad

ORCID ID

Contact details

Trauma & Orthopaedics
Ground Floor
250 Euston Road
London
NW1 2PG
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1.5

Study information

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

Acronym

Study hypothesis

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

Ethics approval

Not provided at time of registration

Study design

Single centre prospective partially blinded randomised controlled parallel three group trial

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

Osteoarthritis or rheumatoid arthritis affecting the knee

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

Phase

Not Applicable

Drug names

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

Overall trial start date

01/08/2011

Overall trial end date

31/07/2014

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

90

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

Recruitment start date

01/08/2011

Recruitment end date

31/07/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Orthopaedics and Trauma
University College London Hospitals Ground Floor North 250 Euston Road
London
NW1 2PG
United Kingdom

Sponsor information

Organisation

Joint UCL/UCLH/Royal Free Biomedical Research Unit (UK)

Sponsor details

Ground Floor
Rosenheim Wing
25 Grafton Way
London
WC1E 6DB
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

DJO Surgical (USA)

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

Publication citations

Additional files

Editorial Notes