Knee Replacement Techniques for Osteoarthritis
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Nova Scotia Health Authority
Trial Summary
What is the purpose of this trial?Total Knee Replacement (TKR) is an operation to help with the pain and decreased function that happens with end stage arthritis of the knee. This operation has been shown to be very successful at relieving pain and improving patient mobility; however, some studies have shown that up to 20% of TKR recipients are not happy with their knee replacement.
All of the reasons why some patients are not pleased with the outcome of surgery are not known, but one of the possible causes is the way the implants are placed, or aligned, during surgery. Most TKRs are aligned in a fashion that the bones in the leg are completely straight after surgery. This is known as mechanically aligning a TKR. A different alignment method known as kinematic alignment respects the natural bow legged or knock kneed alignment of the patient. It is hoped that kinematically aligning a knee replacement will improve how the knee feels to the patient and therefore improve their satisfaction.
Another potential factor affecting the outcomes of TKR is obtaining optimal soft tissue balance. The challenge with balancing a TKR is that traditional operative techniques rely on subjective feel of the knee stability during surgery. The balance or tension in the knee can however be objectively measured using specialized intraoperative pressure sensing devices.
The purpose of this study is to assess the impact of kinematically aligned TKR on the pressures measured by Verasense during total knee replacements. The study will also determine if differences in the pressure measured during TKR surgery impact patient outcomes after surgery.
What data supports the effectiveness of the treatment Total Knee Arthroplasty with Verasense sensor for osteoarthritis?
Research shows that kinematically aligned total knee replacements, which are part of the treatment, provide better pain relief and improved function compared to mechanically aligned techniques. Patients experienced better outcomes in terms of pain scores, knee function, and range of movement.
123711How is Total Knee Arthroplasty with Verasense sensor different from other treatments for knee osteoarthritis?
Total Knee Arthroplasty with the Verasense sensor is unique because it uses a sensor to help ensure proper alignment and balance during surgery, which can improve the fit and function of the knee replacement. This approach aims to enhance the precision of the surgery compared to traditional methods, potentially leading to better outcomes for patients.
3491012Is total knee replacement generally safe for humans?
Research shows that total knee replacement, including techniques like kinematic alignment and robotic assistance, is generally safe for humans. Studies have focused on improving the accuracy of the procedure, which helps ensure the prosthesis (artificial joint) is properly aligned, reducing risks like wear and loosening over time.
13568Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Eligibility Criteria
This trial is for adults aged 21-80 with painful knee arthritis needing a total knee replacement. Candidates should be able to follow the study's procedures and self-evaluate their progress. They must have varus alignment (bow-leggedness) but no other details on exclusions are provided.Inclusion Criteria
I have severe knee pain that requires a total knee replacement.
I am between 21 and 80 years old.
Exclusion Criteria
My BMI is over 45.
I have a condition that affects my muscle control.
I have severe bone loss.
I have a health condition that makes it hard for me to walk.
I am younger than 21 or older than 81.
I am unable to give my consent.
I do not have inflammatory arthritis, posttraumatic osteoarthritis, or arthritis from sepsis.
I have or had an infection.
I cannot undergo major surgery due to my health condition.
Participant Groups
The study tests if kinematically aligning knee implants during surgery, which respects natural leg curvature, improves patient satisfaction compared to traditional straight alignment. It uses Verasense sensors to measure pressure and balance in the knee during operation.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TKA with Verasense sensorExperimental Treatment1 Intervention
Total Knee Arthroplasty (TKA) with Verasense sensor for Intraoperative Balancing: Surgeon will attempt to optimize the intraoperative pressures using the data from the Verasense sensor
Group II: Standard of Care TKAPlacebo Group1 Intervention
Standard of Care Total Knee Arthroplasty (TKA): No data from the Verasense sensor will be used to influence the surgery
Total Knee Arthroplasty is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
🇪🇺 Approved in European Union as Total Knee Arthroplasty for:
- Severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and avascular necrosis of the femoral condyle
🇺🇸 Approved in United States as Total Knee Replacement for:
- Severe knee pain and disability due to degenerative joint disease, rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and avascular necrosis of the femoral condyle
🇨🇦 Approved in Canada as Total Knee Arthroplasty for:
- Severe knee pain and disability due to degenerative joint disease, rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and avascular necrosis of the femoral condyle
🇯🇵 Approved in Japan as Total Knee Replacement for:
- Severe knee pain and disability due to degenerative joint disease, rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and avascular necrosis of the femoral condyle
🇨🇳 Approved in China as Total Knee Arthroplasty for:
- Severe knee pain and disability due to degenerative joint disease, rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and avascular necrosis of the femoral condyle
🇨🇭 Approved in Switzerland as Total Knee Replacement for:
- Severe knee pain and disability due to degenerative joint disease, rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and avascular necrosis of the femoral condyle
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Nova Scotia Health AuthorityHalifax, Canada
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Who is running the clinical trial?
Nova Scotia Health AuthorityLead Sponsor
References
Kinematic navigation in total knee replacement--experience from the first 50 cases. [2016]Proper alignment of the prosthesis is critical in total knee replacement (TKR) to minimize long-term wear, risk of osteolysis, and loosening of the prosthesis. This study examined the accuracy of lower limb alignment obtained using a kinematic navigation system for TKR, and the extra time needed to adopt this system.
A randomised controlled trial of kinematically and mechanically aligned total knee replacements: two-year clinical results. [2022]We have previously reported the short-term radiological results of a randomised controlled trial comparing kinematically aligned total knee replacement (TKR) and mechanically aligned TKR, along with early pain and function scores. In this study we report the two-year clinical results from this trial. A total of 88 patients (88 knees) were randomly allocated to undergo either kinematically aligned TKR using patient-specific guides, or mechanically aligned TKR using conventional instruments. They were analysed on an intention-to-treat basis. The patients and the clinical evaluator were blinded to the method of alignment. At a minimum of two years, all outcomes were better for the kinematically aligned group, as determined by the mean Oxford knee score (40 (15 to 48) versus 33 (13 to 48); p = 0.005), the mean Western Ontario McMaster Universities Arthritis index (WOMAC) (15 (0 to 63) versus 26 (0 to 73); p = 0.005), mean combined Knee Society score (160 (93 to 200) versus 137 (64 to 200); p= 0.005) and mean flexion of 121° (100 to 150) versus 113° (80 to 130) (p = 0.002). The odds ratio of having a pain-free knee at two years with the kinematically aligned technique (Oxford and WOMAC pain scores) was 3.2 (p = 0.020) and 4.9 (p = 0.001), respectively, compared with the mechanically aligned technique. Patients in the kinematically aligned group walked a mean of 50 feet further in hospital prior to discharge compared with the mechanically aligned group (p = 0.044). In this study, the use of a kinematic alignment technique performed with patient-specific guides provided better pain relief and restored better function and range of movement than the mechanical alignment technique performed with conventional instruments.
Navigation-assisted versus conventional total knee replacement: no difference in patient-reported outcome measures (PROMs) at 1 and 2 years. [2018]Navigation technique for total knee replacement has been shown to improve accuracy of prosthesis alignment in several studies. The purpose was to compare the patient-reported outcome measures in primary total knee replacement (TKR) using navigation versus conventional surgical technique at 1- and 2-year follow-up.
Standard versus physiologic bone preparation in total knee arthroplasty and the effect on joint space opening. [2018]Total knee arthroplasty is an effective treatment for osteoarthritis. Restoration of physiologic varus alignment may restore the native soft tissue tension and improve outcomes.
Current evidence base for kinematic alignment. [2021]Kinematic alignment recently became an alternative alignment option for total knee arthroplasty (TKA). Beside previous studies assessing mechanical alignment in comparison to unintentional malalignment of TKA in terms of implant survival and clinical outcome, more and more studies have focused on the direct comparison of intentional kinematic alignment with mechanical alignment of the prosthesis. In the past 5 years the number of studies with respect to kinematic alignment has risen from 11 to 91 studies.
Safe and effective use of active robotics for TKA: Early results of a multicenter study. [2022]A novel active robotic system for total knee arthroplasty (TKA) performs automated milling of bone surfaces. Study objectives were to assess system safety and effectiveness in a US population.
Robotic-assisted surgery and kinematic alignment in total knee arthroplasty (RASKAL study): a protocol of a national registry-nested, multicentre, 2×2 factorial randomised trial assessing clinical, intraoperative, functional, radiographic and survivorship outcomes. [2022]Robot-assisted surgery (RAS) and kinematic alignment (KA) are being increasingly adopted to improve patient outcomes in total knee arthroplasty (TKA). There is uncertainty around the individual or combined effect of these concepts compared with computer-assisted surgery (CAS) and mechanical alignment (MA), respectively. This study aims to assess the effectiveness of RAS, KA or both to improve clinical outcomes, functional measures, radiographic precision and prosthetic survivorship when compared with current gold standards of surgical care.
Comparison of CT with intra-operative navigation reported implant position utilising a robotic assisted technique in total knee arthroplasty. [2022]Validation of navigated total knee arthroplasty (TKA) systems assists clinicians in making treatment decisions. The aim of this study was to independently review a navigation assisted robotic system for use in TKA.
Postoperative limb alignment in total knee replacement. Conventional versus navigated versus robotic techniques. [2023]Our objective was to compare the coronal mechanical axis after total knee replacement (TKR) obtained in three groups of patients subjected to conventional, navigated, and robotic surgery.
Analysis of Short-Term Clinical and Functional Outcomes in Patients Undergoing Total Knee Arthroplasty with Kinematic Alignment Technique. [2023]Surgery remains the best option for more advanced stages of knee osteoarthritis (OA). Kinematic alignment (KA) is an innovative surgical technique that aims to co-align the rotational axes of the femoral, tibial, and patella components with the three kinematic axes of the knee. This study aims to evaluate and analyze short-term clinical, psychological, and functional outcomes in patients undergoing total knee replacement with the KA technique.
Medial tibial bone resorption following total knee arthroplasty comparing a traditional with a kinematic design. [2023]New total knee prostheses are being designed to improve clinical outcome, survivorship and patient satisfaction following total knee arthroplasty (TKA). A new knee system was developed with improvements in patellofemoral joint, trochlear geometry, polyethylene formulation and tibial baseplate. Aim of this study was to compare the newer kinematic knee system with its existing predecessor knee system in terms of clinical outcome, revision rates, radiographic outcomes specifically medial tibial bone resorption.
A novel robot-assisted knee arthroplasty system (ROSA) and 1-year outcome: A single center experience. [2023]Total knee arthroplasty is a successful procedure in the treatment of knee osteoarthritis. Searches in surgical technique have focused surgeons in particular on implant alignment. For this purpose, the use of robot-assisted total knee arthroplasty has become increasingly common in the last 10 years.