Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Comparison of post-operative function following MAKOplasty® unicondylar knee arthroplasty, using MAKOplasty® and the MAKO RIO® System, versus OXFORD® partial knee arthroplasty
Acronym
Study hypothesis
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
Pending as of 26/01/2010:
1. NHS Research Ethics Committee, Glasgow Royal Infirmary
2. Ethics Committee, Research and Innovation, University of Strathclyde
Study design
Prospective single-blind single-centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not yet available in web format, please contact iain.anthony@ggc.scot.nhs.uk to request a patient information sheet.
Condition
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
Phase
Drug names
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 trial start date
19/04/2010
Overall trial end date
18/10/2021
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
All
Gender
Both
Target number of participants
150 (75 within each treatment group)
Participant 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
Recruitment start date
19/04/2010
Recruitment end date
18/10/2021
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Glasgow Royal Infirmary
Glasgow
G4 0SF
United Kingdom
Sponsor information
Organisation
NHS Greater Glasgow and Clyde (UK)
Sponsor details
4th Floor Walton Building
Glasgow Royal Infirmary
84 Castle Street
Glasgow
G4 0SF
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Industry
Funder name
MAKO Surgical Corporation
Alternative name(s)
Mako Surgical
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United States of America
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
Basic results (scientific)
Publication list