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
| ISRCTN | ISRCTN60834248 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60834248 |
| Secondary identifying numbers | 1.5 |
- Submission date
- 30/06/2011
- Registration date
- 01/08/2011
- Last edited
- 12/02/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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 September 2019
Who is funding the study?
DJO Surgical (USA)
Who is the main contact?
Professor Fares Haddad
Contact information
Scientific
Trauma & Orthopaedics
Ground Floor
250 Euston Road
London
NW1 2PG
United Kingdom
Study information
| Study design | Single centre prospective partially blinded randomised controlled parallel three group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | NRES Committee London City & East, 12/03/2012, ref: 11/LO/1390 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/08/2011 |
| Completion date | 30/09/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 90 |
| Key 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 surgeons 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 patients first TKR |
| Key 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 |
| Date of first enrolment | 01/08/2011 |
| Date of final enrolment | 25/08/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Ground Floor North
250 Euston Road
London
NW1 2PG
United Kingdom
Sponsor information
University/education
Ground Floor
Rosenheim Wing
25 Grafton Way
London
WC1E 6DB
England
United Kingdom
"ROR" |
https://ror.org/02jx3x895 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal in 2019. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Editorial Notes
12/02/2018: The following changes were made:
1. Ethics approval, publication and dissemination plan, and participant level data was added.
2. Recruitment end date was changed from 31/07/2014 to 25/08/2017.
3. Overall trial end date was changed from 31/07/2014 to 30/09/2019.
29/01/2018: No publications found, verifying study status with principal investigator.
