Comparison of post-operative function following MAKOplasty® unicondylar knee arthroplasty, using MAKOplasty® and the MAKO RIO® System, versus OXFORD® partial knee arthroplasty

HS Greater Glasgow and Clyde (UK)0 个研究点目标入组 139 人开始时间: 2010年2月5日最近更新: 2023年3月13日

适应症

试验速览

2016 Results article in https://www.ncbi.nlm.nih.gov/pubmed/27098321 results 2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29162608 results 2018 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/29524796 1-year outcomes 2018 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/29627257 2-year outcomes 2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/34058870/ five-year outcomes (added 02/06/2021)

•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

•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

发起方

HS Greater Glasgow and Clyde (UK)