Knee Replacement Techniques for Osteoarthritis

Overseen By Research Manager

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nova Scotia Health Authority

Disqualifiers: Inflammatory arthritis, Osteoporosis, Neuromuscular, others

Compensation: Varies

Number of Visits: 3

Duration: Intra-operative

60 Participants Needed

What You Need to Know Before You Apply

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.

Will 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.

Is 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. ^{1 2 3 4 5}

How 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. ^{2 6 7 8 9}

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. ^{1 2 10 11 12}

Are You a Good Fit for This Trial?

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

Varus alignment

Ability to give informed consent

Patients willing and able to comply with follow-up requirements and self-evaluations

Exclusion Criteria

Valgus alignment

My BMI is over 45.

I have a condition that affects my muscle control.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Total Knee Arthroplasty (TKA) with or without the use of Verasense sensor for intraoperative balancing

Intra-operative

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery, including kinematic gait assessment and health outcome questionnaires

2 years

Multiple visits over 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Total Knee Arthroplasty
• Total Knee Arthroplasty with Verasense sensor

Trial Overview 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.

How Is the Trial Designed?

Group I: TKA with Verasense sensor Experimental Treatment 1 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 TKA Placebo Group 1 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

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+

Published Research Related to This Trial

In a study of 351 patients undergoing total knee replacement, the use of navigation techniques did not result in significantly better patient-reported outcomes compared to conventional surgical methods at both 1- and 2-year follow-ups.

While there was a notable improvement in physical function scores for the navigation group at the 1-year mark, this difference was not sustained at the 2-year follow-up, indicating that both techniques yield similar long-term patient satisfaction and quality of life outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Navigation-assisted versus conventional total knee replacement: no difference in patient-reported outcome measures (PROMs) at 1 and 2 years. Singisetti, K., Muthumayandi, K., Abual-Rub, Z., et al.[2018]

This study will evaluate the effectiveness of robot-assisted surgery (RAS) and kinematic alignment (KA) in total knee arthroplasty (TKA) compared to traditional methods, involving 300 patients and assessing outcomes over 2 years using the Knee injury and Osteoarthritis Outcome Score (KOOS-12).

The research aims to determine not only the clinical and functional benefits of RAS and KA but also their impact on radiographic precision and long-term prosthetic survivorship, providing a comprehensive analysis of these modern surgical techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. MacDessi, SJ., Wernecke, GC., Bastiras, D., et al.[2022]

In a study of 88 patients, kinematically aligned total knee replacement (TKR) showed significantly better clinical outcomes at two years compared to mechanically aligned TKR, including higher Oxford knee scores and better pain relief.

Patients who underwent kinematically aligned TKR experienced improved function, with greater knee flexion and the ability to walk further before discharge, indicating enhanced recovery compared to those with mechanically aligned TKR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised controlled trial of kinematically and mechanically aligned total knee replacements: two-year clinical results. Dossett, HG., Estrada, NA., Swartz, GJ., et al.[2022]

The use of a kinematic navigation system in total knee replacement (TKR) significantly improves the accuracy of limb alignment compared to conventional methods, with a postoperative mechanical axis deviation of 1.89 degrees versus 3.38 degrees.

Although the navigation system requires about 8 extra minutes of operation time, it is easy to use and results in less variation in alignment, which can help reduce long-term complications like wear and loosening of the prosthesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kinematic navigation in total knee replacement--experience from the first 50 cases. Chang, CW., Yang, CY.[2016]

In a study of 88 total knee arthroplasties (TKAs) comparing a new kinematic knee prosthesis to a traditional design, both groups showed similar clinical outcomes after 5 years, with no significant differences in knee society scores or range of motion.

However, the new prosthesis group reported lower incidences of anterior knee pain (8.5% vs 21.9%) and crepitation (14.6% vs 32.9%), suggesting improved patient satisfaction with the newer design.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medial tibial bone resorption following total knee arthroplasty comparing a traditional with a kinematic design. Saini, MK., Reddy, CD., Reddy, NR., et al.[2023]

In a multicenter clinical trial involving 115 patients, the novel active robotic system for total knee arthroplasty (TKA) demonstrated no pre-defined adverse events, indicating a high level of safety.

The robotic system effectively achieved limb alignment, with only 11.2% of cases showing postoperative alignment more than ±3° from the planned target, suggesting its efficacy in improving surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safe and effective use of active robotics for TKA: Early results of a multicenter study. Stulberg, BN., Zadzilka, JD., Kreuzer, S., et al.[2022]

In a study of 87 patients undergoing robotic-assisted total knee arthroplasty (TKA), the navigation system demonstrated high accuracy in component positioning, with over 94% of measurements within 3° of the postoperative CT scan results.

The mean differences between the navigation software estimates and the actual postoperative CT scans were minimal, indicating that this robotic system can effectively assist in achieving precise alignment of knee components during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of CT with intra-operative navigation reported implant position utilising a robotic assisted technique in total knee arthroplasty. Sharma, N., Berera, V., Petterwood, J.[2022]

Kinematic alignment is emerging as a viable alternative to mechanical alignment in total knee arthroplasty (TKA), with a significant increase in research from 11 to 91 studies in the past 5 years.

This review aims to summarize the growing body of literature comparing the outcomes of kinematic alignment versus mechanical alignment, highlighting the evolving understanding of their impact on implant survival and clinical results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current evidence base for kinematic alignment. Tuecking, LR., Savov, P., Windhagen, H., et al.[2021]

The kinematic alignment (KA) technique in total knee replacement surgery led to significant improvements in clinical, psychological, and functional outcomes for 12 patients, as measured by various tests before and after surgery.

Patients experienced a fast postoperative recovery, with notable enhancements in their scores from the day after surgery to 14 days post-operation, indicating the potential effectiveness of KA in treating knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of Short-Term Clinical and Functional Outcomes in Patients Undergoing Total Knee Arthroplasty with Kinematic Alignment Technique. Giorgino, R., Nannini, A., Scuttari, E., et al.[2023]

In a study using six paired fresh-frozen knee specimens, total knee arthroplasty (TKA) with physiologic alignment resulted in balanced medial-lateral soft tissue tension but showed greater laxity in flexion gaps compared to the intact knee.

Standard neutral alignment TKA maintained the original flexion gaps of the intact knee, suggesting it may be a safer option for preserving knee stability post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standard versus physiologic bone preparation in total knee arthroplasty and the effect on joint space opening. Burkhart, TA., Herman, BV., Perry, K., et al.[2018]

In a study of 124 knees undergoing total knee replacement, no significant differences were found in post-operative tibiofemoral angles among conventional, navigated, and robotic surgery groups, indicating similar alignment outcomes overall.

However, a higher percentage of patients who underwent robotic surgery showed improved mechanical alignment compared to those who had conventional surgery, suggesting that robotic techniques may offer some advantages in achieving better limb alignment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative limb alignment in total knee replacement. Conventional versus navigated versus robotic techniques. Durán-Serrano, M., Lizcano-Palomares, M., Laclériga-Giménez, AF., et al.[2023]

In a study of 46 patients undergoing robotic-assisted total knee arthroplasty, significant improvements were observed in knee function, with Oxford scores increasing from an average of 18.5 to 43.5 for the right knee and from 16.9 to 43.4 for the left knee post-surgery.

The Knee Society Scores (KSS) also showed substantial enhancement, rising from 49.7 to 89.2 for the right knee and from 46.5 to 89.8 for the left knee, indicating that robotic assistance in knee surgery can lead to effective functional outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel robot-assisted knee arthroplasty system (ROSA) and 1-year outcome: A single center experience. Demirtas, Y., Emet, A., Ayik, G., et al.[2023]

Citations

1. Germany pubmed.ncbi.nlm.nih.gov

Navigation-assisted versus conventional total knee replacement: no difference in patient-reported outcome measures (PROMs) at 1 and 2 years. [2018]

2. England pubmed.ncbi.nlm.nih.gov

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]

3. England pubmed.ncbi.nlm.nih.gov

A randomised controlled trial of kinematically and mechanically aligned total knee replacements: two-year clinical results. [2022]

4. Singapore pubmed.ncbi.nlm.nih.gov

Kinematic navigation in total knee replacement--experience from the first 50 cases. [2016]

5. Germany pubmed.ncbi.nlm.nih.gov

Medial tibial bone resorption following total knee arthroplasty comparing a traditional with a kinematic design. [2023]

6. India pubmed.ncbi.nlm.nih.gov

Safe and effective use of active robotics for TKA: Early results of a multicenter study. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Comparison of CT with intra-operative navigation reported implant position utilising a robotic assisted technique in total knee arthroplasty. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Current evidence base for kinematic alignment. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Analysis of Short-Term Clinical and Functional Outcomes in Patients Undergoing Total Knee Arthroplasty with Kinematic Alignment Technique. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Standard versus physiologic bone preparation in total knee arthroplasty and the effect on joint space opening. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Postoperative limb alignment in total knee replacement. Conventional versus navigated versus robotic techniques. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

A novel robot-assisted knee arthroplasty system (ROSA) and 1-year outcome: A single center experience. [2023]