Randomised controlled trial to assess an all-polyethylene tibia medial rotation knee implant compared to a metal-backed tibia implant
| ISRCTN | ISRCTN12532998 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12532998 |
| IRAS number | 164614 |
| Secondary identifying numbers | MOP0001, IRAS 164614 |
- Submission date
- 17/12/2014
- Registration date
- 15/04/2015
- Last edited
- 18/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Total knee replacement has been performed for over 40 years as last resort treatment of arthritis and damaged knee joints. A knee replacement aims to reduce pain, stiffness and immobility. The most common measures of success in joint replacement surgery to date has been the rate at which a revision is required (further surgery to replace worn out components etc). The success of an implant can also be determined using validated patient reported outcome measures (PROMs) which are defined as validated measures to assess any aspect of health which come from the patient themselves.
The Medial Rotation Knee (MRK) from MatOrtho Limited is a total knee replacement system that was CE marked in 1994. It has proven to be a very successful design of knee replacement and shows the best revision rates at only 1.83% in 7 years from the UK. This study will compare two types of knee replacement implants (all-polyethylene tibia medial rotation knee implant vs metal-backed tibial medial rotation knee).
Who can participate?
Adult patients undergoing total knee arthroplasty for any indication.
What does the study involve?
Participants will be allocated to one of the two groups: 75 will receive metal-backed MRK implants and 75 will receive all-polyethylene tibia MRK implants. They will then be followed up over a 2 year period, during which they will be asked to complete various PROMs questionnaires, before and after the operation.
What are the possible benefits and risks of participating?
Taking part in the study will not impose any further risks on to the patient. The patients will be asked to attend an extra follow up appointment 2 years post-operatively and travel expenses will be offered to the patients to minimise any inconvenience. The potential risks of the surgery will remain the same regardless of whether the patient takes part or not, this will be fully explained to the patient during the consent process.
Where is the study run from?
The study is run by the Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust and he patients will be recruited from 3 NHS sites across the UK.
When is the study starting and how long is it expected to run for?
July 2014 to December 2018 (updated 03/07/2019, previously: July 2018)
Who is funding the study?
MatOrtho Ltd.
Who is the main contact?
Dr Catherine Whitall
catherine.whittall@rjah.nhs.uk
Contact information
Public
MatOrtho Limited
13 Mole Business Park
Leatherhead
KT22 7BA
United Kingdom
| Phone | +44 (0)1372 224234 |
|---|---|
| laura.richards@matortho.com |
Scientific
MatOrtho Limited
13 Mole Business Park
Leatherhead
KT22 7BA
United Kingdom
| Phone | +44 (0)1372 224234 |
|---|---|
| laura.richards@matortho.com |
Study information
| Study design | Multi-centre randomised controlled imterventional study |
|---|---|
| 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 to request a patient information sheet |
| Scientific title | Medial Rotation Knee Randomised Controlled Trial Allpolyethylene versus Metal backed tibia |
| Study acronym | MRK Poly Vs Metal |
| Study objectives | There is no difference in range of motion between the all-polyethylene tibia and metal-backed tibial medial rotation knee implants. |
| Ethics approval(s) | NRES Committee North West - Greater Manchester South, 26/02/2015, ref: 15/NW/0005 |
| Health condition(s) or problem(s) studied | Patients undergoing total knee arthroplasty for any indication. |
| Intervention | Participants in the study will all be undergoing total knee arthroplasty, group A will receive the all-polyethylene tibia medial rotation knee implant whereas group B will receive the metal-backed tibial medial rotation knee. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Medial Rotation Total Knee Replacement |
| Primary outcome measure | Compare the mean range of motion (ROM) of the all-polyethylene tibia MRK to the metal-backed tibia MRK. A difference of means in ROM of 5 degrees or more will be used to determine if there is a difference in the clinical outcome of the all-polyethylene tibia and the metal-backed tibia. |
| Secondary outcome measures | Patient reported outcome measures will be compared for the two treatment arms, including the Oxford Knee Score, the EQ-5D, Modified Forgotten Joint Score, and the UCLA Activity score. |
| Overall study start date | 22/07/2014 |
| Completion date | 31/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 150 |
| Total final enrolment | 162 |
| Key inclusion criteria | 1. Primary total knee arthroplasty (for any indication) 2. Informed consent to participate in the study provided by the patient 3. Patients aged over 18 years 4. Able to understand and respond to Patient-reported outcome measures (PROMs) for the duration of the study period |
| Key exclusion criteria | 1. Severe muscular, neurological or vascular deficiencies which compromise the affected extremity 2. Bone deficiency or deficient bone quality likely to compromise the implant (as determined by surgical team on pre-operative radiographs) 3. Severe ligament instability 4. Hypersensitivity to the materials used 5. Alcoholism or other addictive disorders 6. Sepsis 7. Osteomyelitis 8. Osteomalacia 9. Severe osteoporosis – clinical judgement 10. Metabolic disorders which may impair bone formation 11. Patients lacking capacity to provide consent 12. Those whose prospects for a recovery to independent mobility would be compromised by known pre-existing medical conditions 13. Patients who have their contralateral knee already in the study |
| Date of first enrolment | 09/04/2015 |
| Date of final enrolment | 31/12/2018 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Shropshire
SY10 7AG
United Kingdom
Sponsor information
Industry
13 Mole Business Park
Leatherhead
KT22 7BA
United Kingdom
| Website | www.matortho.com |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/07/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Current publication and dissemination plan as of 24/08/2023: Target 2024 Previous publication and dissemination plan: To be confirmed at a later date |
| IPD sharing plan | Current individual participant data (IPD) sharing plan as of 24/08/2023: The datasets generated during and/or analysed during the current study are not expected to be made available Previous individual participant data (IPD) sharing plan: The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
18/12/2024: The intention to publish date was changed from 01/12/2024 to 01/07/2025.
24/08/2023: The following changes were made to the study record:
1. IRAS number added.
2. The intention to publish date was changed from 30/12/2023 to 01/12/2024.
3. IPD sharing plan and publication and dissemination plan updated.
07/12/2022: The intention to publish date was changed from 30/12/2022 to 30/12/2023.
24/01/2022: The following changes have been made:
1. The intention to publish date has been changed from 01/06/2022 to 30/12/2022.
2. The total final enrolment number has been added.
3. The individual participant data (IPD) sharing statement has been added and the IPD sharing summary has been changed from "Available on request" to "Published as a supplement to the results publication".
4. The study contact has been updated.
03/07/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 07/01/2016 to 31/12/2018.
2. The overall end date was changed from 06/07/2018 to 31/12/2021.
3. The intention to publish date was added.
4. The plain English summary was updated to reflect these changes.
30/03/2016: Ethics approval information added.
