View clinical trials related to Knee.
Filter by:A total knee replacement is the removal of parts of the knee joint, that have become damaged due to osteoarthritis, and replacing these with artificial implants. The placement of these artificial implants and how they are aligned with each other is important because they can impact overall knee function and the long-term survival of the implant. It is reported that up to 34% of all patients following total knee replacement (TKR) have poor outcomes functionally. There have been significant developments in knee replacement surgery over recent years. In particular, the introduction of robotic surgical systems, such as the NAVIO and CORI systems (Smith+Nephew Plc). The NAVIO and CORI Surgical Systems are hand-held devices which can support the surgeon with the knee replacement procedure, the systems are image-free and do not require the patient to undergo any scans (such as CT scans). During the surgery, the surgeon uses the NAVIO/CORI hand-held device to map specific landmarks within the knee joint and determines the desired alignment using associated computer software. The tools to remove the bone and place the implants are controlled by the surgeon with the guidance of the NAVIO/CORI software. Comparisons of robotic systems to conventional instruments have demonstrated that robotic platforms produce fewer positioning errors in total knee replacement. This can result in more precise knee alignment and better outcomes following surgery. With both the NAVIO and CORI Surgical Systems there is a reduction in radiation exposure due to them being image-free. At present, there is some evidence available for the long-term outcomes of total knee replacement implanted using robotic assistance (i.e. 2-10 years) however this study is designed to look at the early outcomes following TKR. There is no literature to date to show that robotic-assisted TKR is superior to conventional methods, within the early post-operative period (up to 12 months). This study is designed to show that the NAVIO/CORI surgical systems are better than conventional methods for TKR. The hypothesis is that they will be cost-effective, will reduce the time a patient spends in hospital following their surgery, will improve patient satisfaction during the early recovery period and will improve the patient's early post-operative mobility and function.
To evaluate the performance of the CORI™ KNEE TENSIONER as an accessory to the CORI™ Surgical System.
Background: REAL INTELLIGENCE™ CORI™ (CORI Robotics) is a computer-assisted orthopaedic surgical navigation and burring system. CORI Robotics is designed to help surgeons in planning and executing certain types of knee surgery involving bone preparation. These types of surgery are called 'unicondylar knee arthroplasty' (UKA) and 'total knee arthroplasty' (TKA). Purpose: This study is being carried out to demonstrate the safety and effectiveness of the CORI Robotics in TKA procedure. The data collected will be used to demonstrate the safety and effectiveness of CORI and to register CORI in China mainland. The primary objective of this study is to evaluate the use of CORI in TKA procedure in achieving post-operative leg alignment as compared to procedures using conventional manual instruments. Research participants / locations: 140 research participants will be recruited from up to 8 sites in 3 countries globally (Australia, China Mainland, Hong Kong and New Zealand). There will be 70 patients having TKA using CORI and 70 patients having TKA using conventional procedure.
Background: The JOURNEY II BCS Total Knee System (JOURNEY II Bi-cruciate Stabilized Total Knee System) consists of femoral component made from oxidized zirconium (OXINIUM) The JOURNEY II CR Total Knee System (JOURNEY II Cruciate Retaining Total Knee System ) consists of femoral component made from oxidized zirconium (OXINIUM) Purpose: Post-market evidence generation for JOURNEY II BCS and JOURNEY II CR Total Knee System Objectives: 1. Evaluate the performance of JOURNEY II TKA in Asia-Pacific (APAC) patient populations 2. Establish the equivalent performance between JOURNEY II BCS and JOURNEY II CR to support adoption of JOURNEY II CR Research participants / locations: A total of at least 176 knees' information will be collected in up to 10 sites. There will be at least eighty-eight (88) knees for JOURNEY II CR TKA group and at least 88 knees for JOURNEY II BCS TKA group.
Background: The JOURNEY II CR Total Knee System consists of femoral component made from oxidized zirconium (OXINIUM) Purpose: Post-market evidence generation for JOURNEY II CR Total Knee System Objectives: Evaluate the performance of JOURNEY II CR TKA in APAC populations Evaluate the impact of patella resurfacing on the outcomes of JOURNEY II CR TKA Research participants / locations: A total of up to 480 knees' information will be collected in up to 15 sites in India, China mainland, Hong Kong, Singapore, Thailand and Japan There will be up to 240 knees for resurfaced patella group and up to 240 knees for un-resurfaced patella group.
Background: REAL INTELLIGENCE™ CORI™ (CORI Robotics) is a computer-assisted orthopaedic surgical navigation and burring system. CORI Robotics is designed to help surgeons in planning and executing certain types of knee surgery involving bone preparation. These types of surgery are called 'unicondylar knee arthroplasty' (UKA) and 'total knee arthroplasty' (TKA). Purpose: This study is being carried out to demonstrate the safety and effectiveness of the CORI Robotics. The data collected will be used to meet the post-market clinical follow-up requirement in Europe and to support claims and publications. Objectives: The primary objective of this study is to evaluate the use of CORI Robotics in UKA and TKA procedures in achieving post-operative leg alignment to check that the results of the operation are similar to what the surgeon originally planned. Research participants / locations: 140 research participants will be recruited from up to 8 sites in 4 countries globally (UK, US, Germany and India). There will be 70 patients having UKA surgery and 70 patients having TKA surgery.
The study objective is to assess patient satisfaction after the surgery with a custom-made CE marked implant (ORIGIN®) versus off-the-shelf (VANGUARD PS) device, and to document the clinical and device performance outcomes of the ORIGIN System used in routine hospital practice in a large patient cohort treatment of total knee arthroplasty. The hypothesis is that patients receiving ORIGIN implants will experience a more natural feel of the prosthesis during the first year after the surgery compared to patients receiving VANGUARD implants (as measured with FJS), and slightly significant improvement at the following interval of 2 years. The overall patient satisfaction is expected to be improved after 2 years follow-up. It is also supposed that the overall patient satisfaction is expected to be higher with ORIGIN PS than with VANGUARD PS treatment.
This study will be a randomized controlled trial. This study will be conducted in Horizon Hospital Lahore. A sample size of 26 patients will be taken. Patients will be divided into two groups by lottery method. Group A will be treated with Structured Rehabilitation program along with conventional physiotherapy while Group B will be treated with conventional physiotherapy only. Both groups will receive treatment for 4 weeks,3 sessions per week. The outcome measures Numeric pain rating scale(NPRS),6 minutes' walk test and Womac scale will be measured at baseline and at the end of 4th week. Data will be analyzed by SPSS 25.
This study is a prospective, open-label, post-market, non-randomized, multi-center clinical evaluation of the Triathlon Total Knee System using the Triathlon PSR Tibial Insert for primary total knee arthroplasty (TKA) in a consecutive series of patients who meet the eligibility criteria. The SF-36 score of subjects receiving the Triathlon Total Knee with the Triathlon PSR insert is expected to be comparable with that of subjects receiving historical Triathlon PS cemented constructs.
The objective of this study is to determine and compare the in vivo kinematics and vibroarthrography (VAG) signals for subjects implanted with Journey II Bi-Cruciate Stabilized (BCS), CR (Cruciate Retaining), and Bi-Cruciate Retaining (XR) TKAs.