Comparison of haptic assisted versus non-assisted uni-compartmental knee arthroplasty
| ISRCTN | ISRCTN77119437 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77119437 |
- Submission date
- 26/01/2010
- Registration date
- 05/02/2010
- Last edited
- 03/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Partial knee replacements are a common surgical treatment for knee arthritis and most patients are satisfied with manual surgery. However, robotic-assisted surgery has the potential to offer more precise implant placement with higher accuracy in bone removal and less blood loss during surgery. However, more evidence is needed to know whether manual or robotic-assisted surgery was of more benefit to patients. This study aims to compare the short and long-term patient-reported clinical outcomes from robotic-assisted or manual surgery in partial knee replacements.
Who can participate?
Patients with osteoarthritis who require a partial knee replacement
What does the study involve?
Participants will be randomly allocated to either receive manual or robotic-assisted partial knee replacement surgery. The study will also involve the completion of questionnaires at the start of the study and at 3 months, 1, 2, 5 and 10 years following their surgery. Participants will also need to undergo CT scans and x-rays which are required for surgical planning when using the robotic arm in surgery. Participants have an additional pre-operative, 3-month, 1-year and 5-year appointment with the human performance lab which will undertake clinical motion analysis to determine whether either type of intervention has an impact on how they walk.
What are the possible benefits and risks of participating?
Currently, clinicians do not know whether manual or robotic-assisted partial knee replacements offer better outcomes for patients. Manual partial knee replacements are currently the gold standard surgical option for patients needing a partial knee replacement with well-reported implant survivorship and good patient outcomes. However, robotic-assisted surgery offers improved implant placement, less blood loss and a more refined approach to bone removal when determining the implant size to be used. The benefits of robotic surgery have the potential to improve long-term implant survivorship and fewer long-term reinterventions. However, in order to have robot-assisted surgery patients need to undergo CT scans which carry an increased risk of radiation exposure.
Where is the study run from?
Glasgow Royal Infirmary (UK)
When is the study starting and how long is it expected to run for?
April 2010 to January 2023
Who is funding the study?
This study is funded by Stryker Ltd, the company that makes the robot which is used in this study. The study is sponsored by the NHS Greater Glasgow and Clyde and is run independently from the company and funder.
Who is the main contact?
1. Dr James Doonan, James.Doonan@glasgow.ac.uk
2. Mr Mark Blyth, Mark.Blyth@ggc.scot.nhs.uk
Contact information
Scientific
Glasgow Royal Infirmary
Department of Trauma and Orthopaedics
84 Castle Street
Glasgow
G4 0SF
United Kingdom
Public
Gatehouse Building
Glasgow Royal Infirmary
82 Castle street
Glasgow
G4 0RH
United Kingdom
Study information
| Study design | Prospective single-blind single-centre randomized controlled 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 to request a patient information sheet |
| Scientific title | Comparison of post-operative function following MAKOplasty® unicondylar knee arthroplasty, using MAKOplasty® and the MAKO RIO® System, versus OXFORD® partial knee arthroplasty |
| Study acronym | MAKO RCT |
| Study objectives | MAKOplasty® performed with assistive haptic arm technology will result in less variability in post-operative mechanical knee alignment, and an associated improvement in post-operative function, activity and satisfaction, as compared to the standard unicompartmental knee arthroplasty. |
| Ethics approval(s) | Approved 28/04/2010, West of Scotland Research Ethics Service REC 4 (Clinical Research and Development, West Glasgow Ambulatory Care Hospital, Dalnair Street, Glasgow, G3 8SJ, UK; +44 (0)141 232 1808; WoSREC4@ggc.scot.nhs.uk), ref: 10/S0704/12 |
| Health condition(s) or problem(s) studied | Early-mid stage osteoarthritis of the knee |
| Intervention | 1. Treatment group: MAKOplasty® unicondylar knee arthroplasty, using the RESTORIS implant and the MAKO RIO® Robotic Arm Interactive Orthopaedic System 2. Control group: OXFORD® Partial Knee Arthroplasty Total duration of treatment will be 1 - 2 hours. Total duration of follow-up will be 10 years. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Mechanical knee alignment (tibiofemoral angle, degrees) - measured from long-leg scans at 3 months post-operatively |
| Secondary outcome measures | 1. Oxford Knee Scores (OKS) - measured pre-operatively and 3 months, 1, 3, 5 and 10 years post-operatively 2. American Knee Society Score (AKSS) - measured pre-operatively and 3 months, 1, 3, 5 and 10 years post-operatively 3. Pain Visual Analogue Score (VAS) - measured daily for 1 week post-operatively, weekly for 8 weeks post-operatively and at 3 months, 1, 3, 5 and 10 years post-operatively 4. Fuctional section of AKSS - measured daily for 1 week post-operatively, weekly for 8 weeks post-operatively and at 3 months, 1, 3, 5 and 10 years post-operatively 5. 12-item short form health survey (SF-12) - measured pre-operatively and 1 year post-operatively 6. Canadian Occupational Performance Score (COPM) - measured pre-operatively and 1 year post-operatively 7. UCLA activity scale - measured pre-operatively and 1 year post-operatively 8. Hospital Anxiety and Depression (HAD) score - measured pre-operatively and 1 year post-operatively 9. Operation times - measured peri-operatively 10. Complications - measured any time following surgery 11. Knee angles during functional tasks - measured 1 year post-operatively 12. Frequency/type of activity - measured over 1 day at 1 year post-operatively 13. Gait velocity, knee angles and moments - measured 1 year post-operatively |
| Overall study start date | 19/04/2010 |
| Completion date | 31/01/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | All |
| Sex | Both |
| Target number of participants | 150 (75 within each treatment group) |
| Total final enrolment | 139 |
| Key inclusion criteria | 1. Male or female subjects may be recruited to the evaluation 2. Age - there are no restrictions relating to age of the patient. The patient's age must be considered suitable by the clinical investigator for a unicondylar knee arthroplasty using either of the two systems available in the evaluation. 3. Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained 4. Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigation procedures and are willing to return to the hospital for all the required post-operative follow-ups 5. Subjects who require a unicondylar knee arthroplasty for primary surgical management of idiopathic osteoarthritis 6. Patients who in the opinion of the Chief Investigator are considered to be suitable for treatment with a MAKOplasty® and OXFORD® unicondylar knee replacement |
| Key exclusion criteria | 1. Patients who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in the study 2. Patients who require revision knee arthroplasty surgery 3. Patients with any tibial deformity requiring tibial component augmentation 4. Patients whom, in the opinion of the Chief Investigator, require a total knee prosthesis 5. Patients with inflammatory polyarthritis 6. Disorders of the feet, ankles, hips or spine causing significant abnormal gait or significant pain 7. Neurological conditions affecting movement 8. Patients with a pathology which, in the opinion of the Chief Investigator, will adversely affect healing 9. Patients with other disorders which, in the opinion of the Chief Investigator, will/could impair rehabilitation 10. Contra-indications for use of the device, as detailed in the package insert 11. Women who are pregnant. If there is uncertainty over pregnancy then a pregnancy test will be conducted. 12. Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes 13. Subjects who are currently involved in another clinical study with an investigational product 14. Subjects who are currently involved in any injury litigation claims |
| Date of first enrolment | 19/04/2010 |
| Date of final enrolment | 01/01/2013 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Gatehouse Building
Glasgow
G4 0SF
United Kingdom
Sponsor information
Hospital/treatment centre
4th Floor Walton Building
Glasgow Royal Infirmary
84 Castle Street
Glasgow
G4 0SF
United Kingdom
| Website | http://www.nhsggc.org.uk/content/ |
|---|---|
"ROR" |
https://ror.org/05kdz4d87 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Mako Surgical
- Location
- United States of America
Results and Publications
| Intention to publish date | 31/01/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Current publication and dissemination plan as of 12/01/2023: Multiple papers have been published on this study. Links to these papers are listed below: https://pubmed.ncbi.nlm.nih.gov/29524796/ https://pubmed.ncbi.nlm.nih.gov/27098321/ https://pubmed.ncbi.nlm.nih.gov/29627257/ https://pubmed.ncbi.nlm.nih.gov/34058870/ The intention is to publish the final 10-year outcomes in early 2024. Previous publication and dissemination plan: Planned publication in a high-impact peer-reviewed journal. The study protocol, statistical analysis plan and PIS are all available on request (iii-ortho-research@glasgow.ac.uk). |
| IPD sharing plan | Current IPD sharing statement as of 06/02/2023: The datasets generated during and/or analysed during the current study are/will be available on reasonable request and following ethical review from James Doonan (Clinical Trial Manager, james.doonan@glasgow.ac.uk). The type of data that will be shared: Reasonable anonymised patient data and clinical outcomes. Dates of availability: Following publication of the 10-year clinical outcomes and health economic outcomes results (approximately Spring 2024). Whether consent from participants was required and obtained: Consent from participants was obtained but this only pertains to the local sharing of information. And ethical approval would be required for sharing data outside of the current approval. Comments on data anonymization: No identifiable patient data is available and all patients have been provided with a study ID. Any data that could potentially identify participants will be anonymised. Any ethical or legal restrictions: Ethical review would be required prior to sharing. Previous IPD sharing statement: All data generated or analysed during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 20/04/2016 | Yes | No | |
| Results article | results | 01/11/2017 | Yes | No | |
| Other publications | 1-year outcomes | 01/05/2018 | Yes | No | |
| Other publications | 2-year outcomes | 01/07/2018 | Yes | No | |
| Other publications | five-year outcomes | 01/06/2021 | 02/06/2021 | Yes | No |
Editorial Notes
03/03/2023: Plain English summary added.
06/02/2023: IPD sharing statement added.
12/01/2023: Acronym and total final enrolment added. Publication and dissemination plan updated.
20/09/2021: Internal review.
02/06/2021: Publication reference added
15/10/2019: The following changes were made to the trial record:
1. The ethics approval was added.
2. The IPD sharing statement was added to publication and dissemination plan.
3. Publication references added.
04/10/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 18/10/2021 to 01/01/2013.
2. The overall end date was changed from 18/10/2021 to 31/01/2023.
3. The intention to publish date was added.
4. A public contact was added.
