ISRCTN77119437
已完成
未知
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2010年2月5日
概览
- 阶段
- 未知
- 干预措施
- 未指定
- 疾病 / 适应症
- Early-mid stage osteoarthritis of the knee
- 发起方
- HS Greater Glasgow and Clyde (UK)
- 入组人数
- 139
- 状态
- 已完成
- 最后更新
- 3年前
概览
简要总结
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)
研究者
入排标准
入选标准
- •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
排除标准
- •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
结局指标
主要结局
未指定
相似试验
尚未招募
2 期
A clinical trial comparing the functional and aesthetic outcomes of two methods of reconstruction for lip defects in patients who had surgery for oral squamous cell carcinoma.Health Condition 1: C009- Malignant neoplasm of lip, unspecifiedHealth Condition 2: C009- Malignant neoplasm of lip, unspecifiedCTRI/2023/05/053129Dr Nitin Bhola
尚未招募
不适用
A comparison of open surgery versus arthroscopic surgery for resection of the acromioclavicular (AC) joint.Arthritis of the acromioclavicular jointMusculoskeletal - OsteoarthritisSurgery - Surgical techniquesACTRN12612000944831Brendan Coleman50
尚未招募
不适用
A comparison between treatments of the biceps tendon during shoulder replacementArthritis of the shoulderMusculoskeletal - OsteoarthritisSurgery - Surgical techniquesACTRN12612000943842Brendan Coleman70
已完成
4 期
Crystalloids or Colloids for Goal-directed Fluid Therapy With Closed-loop Assistance in Major SurgerySurgeryNCT02312999Brugmann University Hospital160
尚未招募
3 期
extraction of grossly decayed molars using two different methods - A clinical studyHealth Condition 1: K029- Dental caries, unspecifiedCTRI/2023/02/049644Shivya Chopra