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45 active trials for Total Knee Arthroplasty

Efficiency Assessment of the Methodology for the Follow-up of Patients With Knee Prostheses

Total knee arthroplasty (TKA) is currently the international standard for the treatment of degenerative and rheumatological diseases of the knee joint, as well as certain types of fractures. Although TKA is a procedure that has been shown to be effective in relieving pain and improving function in patients with osteoarthritis, approximately 20% of patients are dissatisfied with the results. Traditional methods of assessing the outcome after joint arthroplasty often focus on objective indicators of surgery and neglect the needs and opinions of patients. Because of this, this research project has the aim to know the effectiveness of two models of stabilization of total knee prostheses on the functionality achieved and perceived by the patient, as well as in the knee joint biomechanics during movement in activities of daily life. On the other hand, as a secondary objective, we propose to determine prognostic biomarkers of knee prosthesis function based on radiological information, quantification of cytokines, intra-articular markers, and biomechanical functional evaluation that correlate and predict a correct evolution of patients with a knee replacement. To carry out these objectives, 80 participants will be included with an indication to perform total knee joint replacement surgery. Participants will be randomized allocated into two groups: i. participants with a prosthesis with medial condylar stabilization ii. participants with a traditional prosthesis with central pivot stabilization. Participants will be evaluated at five-times: before surgery, immediate postsurgical, at 3 months of evolution, 6 months of evolution, and one year of evolution.

Start: September 2021
GMK Sphere TiNb Total Knee Arthroplasty PMS Study

Total knee arthroplasty (TKA) is one of the success stories of modern surgery, providing high patient satisfaction outcomes. Total knee prostheses are generally composed by a femoral component articulating on a polyethylene insert and a tibial tray. Recently there has been particular attention on the component material; traditionally femoral components are made of cobalt alloys while tibial baseplates are made, in the great majority of cases, of metallic materials, but also polyethylene versions are available. There has been a degree of acceptance in some countries that metal related pathology may exist as demonstrated by the Australian Arthroplasty register where metal hypersensitivity was reported as the fifth most common cause for revision hip arthroplasty 2012 report, making up for 5.9% of all revisions. The wording was subsequently changed from "metal sensitivity" to "metal related pathology" in the 2014 report with 0.5% of all revision total hip arthroplasties (THA) associated with this term. The same change in terminology was used for TKA with metal sensitivity as a cause for revision in 1.3% of revisions in 2012 and in 2014, 1.8% of revision TKAs attributed to "metal related pathology" . The overall revision rate was 3.45% after 10 years in 396.472 TKAs, suggesting a revision rate of 0.06-0.32% secondary to metal or cement allergies. Up to today there is no question that metallic implants may generate wear debris that cause local reactions. This local reaction is not dose related nor predictable and therefore not purely due to the toxic effect of the debris but possibly due to an immunological host process. Hypersensitivity to metal undoubtedly exists but it cannot be stated at the moment to be an allergic reaction. To prevent issues arising due to metal related pathology, alternative solutions to conventional chrome cobalt material have been proposed, for example ceramic component or implant coating. In particular, TiNbN coating has been proposed by most companies thanks to its excellent biological properties. Preclinical studies have showed a high scratch resistance and low coefficient of friction, more resistance to fretting corrosion, reduction of wear, lower ion release rates and low fatigue cycle, as described in the review of Hove. Clinically, cohort of studies of TiN-coated implants showed an overall survival exceeding 90% with a follow-up of 15 to 77 months and good clinical outcomes. No reports of adverse effects related to TiN coating of CoCrMo knee implants have been showed. There are few studies that compared TiN-coated implants with the same uncoated version. Thienpont, comparing TiN-coated and uncoated CoCrMo implants, showed similar clinical and radiological outcomes at short-term follow up in both patients groups . Overall we can conclude that in literature no adverse events have been reported concerning the TiNbN coating and in particular it has been showed that the coating doesn't not affect the performance of the device if compared with the same uncoated version. The aim of this study is to evaluate the long term clinical and radiological performance of GMK Sphere total knee component, coated version.

Start: February 2020
A Study Using Metaphyseal Cones Versus a Cemented Stem Construct in Revision TKR

Lay Person's Summary: Knee replacement surgery has been successfully carried out for many years. However, in time, some knee replacements will fail-usually either because of wear or loosening of the replacement parts. This may mean the patient has to undergo further surgery-this is known as revision total knee replacement (rTKR). This revision surgery is often more complex than the original operation and presents the operating surgeon with several technical challenges. Of particular concern, is that when the old knee replacement is removed, a large cavity can be left in the bone. The new knee replacement has to be placed into this, but it is essential that it is immediately stable and secure. The large cavity has to be somehow either filled in or bypassed to ensure the new knee replacement is secure enough for early weight-bearing and long term survival. Different techniques have been used for many years to overcome this problem. Firstly, it may be possible to simply cement another knee replacement into the cavity- probably needing more cement than was previously used. An alternative option to this is use a device called a "cone" which sits into the bony cavity created by removing the original knee replacement, and a new knee replacement can be cemented into this. Bone grows onto the cone to ensure its stability. The new knee replacement can have either short stemmed components like the original Total Knee Replacement (TKR), or long stemmed components. All of these types of rTKR are presently in use throughout the United Kingdom (UK). At this point in time, no-one knows which type is best. The research team are planning to run this study to see if it is possible to identify which type of rTKR gives the best outcome for patients. The research team will examine the results in different ways including questionnaires to measure how well the patients feel their knee is performing, specific tests to measure knee function, and by using x-rays and scans. The investigators will identify patients suitable for inclusion in the study from their medical notes, x-rays and scans. If patients consent to be in the study, the research team will randomly allocate them to receive one of the 3 rTKR options (no cone and new knee replacement only, cone with short stemmed components or cone with long stemmed components) and monitor their progress for 5 years after the operation. The investigators will identify patients suitable for inclusion in the study from their medical notes, x-rays and scans. If patients consent to be in the study, the investigators will randomly allocate them to receive one of the 3 rTKR options (no cone and new knee replacement only, cone with short stemmed components or cone with long stemmed components) and monitor their progress for 5 years after the operation. A preliminary analysis of the data generated by the study will be carried out 2.5 years after recruitment of the 1st participant to assess compliance with the study protocol.

Start: June 2017