Early-mid stage osteoarthritis of the knee Musculoskeletal Diseases Polyarthrosis
Conditions
Interventions
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
Sponsors
NHS Greater Glasgow and Clyde (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mechanical knee alignment (tibiofemoral angle, degrees) - measured from long-leg scans at 3 months post-operatively | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Scotland, United Kingdom
Contacts
Public ContactJames Doonan
Outcome results
None listed