Condition category
Musculoskeletal Diseases
Date applied
26/01/2010
Date assigned
05/02/2010
Last edited
01/07/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Mark Blyth

ORCID ID

Contact details

Glasgow Royal Infirmary
Department of Trauma and Orthopaedics
84 Castle Street
Glasgow
G4 0SF
United Kingdom

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 measures

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

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

http://www.nhsggc.org.uk/content/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes