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?

This trial explores new techniques for knee replacements to improve satisfaction for people with knee osteoarthritis. Researchers aim to determine if aligning the knee replacement to match the patient's natural leg shape, known as kinematic alignment, enhances satisfaction. They are also testing whether using a special sensor during surgery to measure knee pressure affects patient outcomes. Eligible participants have knee arthritis and a natural inward leg alignment (varus alignment). As an unphased trial, this study allows patients to contribute to innovative research that could improve future knee replacement procedures.

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.

What prior data suggests that these knee replacement techniques are safe?

Research has shown that using the Verasense sensor in total knee replacement surgery is generally safe for patients. Studies have found no significant increase in complications, such as the need for additional surgery, when the Verasense sensor is used. The sensor aids surgeons in measuring knee pressure to achieve better balance and alignment during the operation.

The goal of using the Verasense sensor in knee replacement is to enhance how the knee feels and functions post-surgery. While the sensor itself doesn't significantly alter knee movement or reduce the likelihood of additional surgery, it does not introduce any extra safety risks. This indicates that the technology is well-tolerated and does not cause new issues for patients undergoing knee replacement surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Total Knee Arthroplasty (TKA) with the Verasense sensor because it represents a new frontier in personalized surgery for osteoarthritis. Unlike standard knee replacement surgeries, which rely on the surgeon's experience to balance the knee, this method uses the Verasense sensor to provide real-time data on intraoperative pressures. This allows surgeons to optimize the balance of the knee during the operation, potentially leading to better outcomes and quicker recovery for patients. By integrating advanced sensor technology, this approach aims to enhance precision and improve the overall success of knee replacements.

What evidence suggests that these knee replacement techniques could be effective for osteoarthritis?

This trial will compare two techniques for total knee arthroplasty (TKA) in patients with osteoarthritis. One group will receive TKA with the Verasense sensor, which research has shown can improve knee balance. Some studies have found that these sensors can reduce imbalance in the knee, potentially leading to more stable knees after surgery. Early results also suggest that patients experience better outcomes when these sensors are used. However, other studies indicate that while the sensors help with balance, they do not significantly improve knee mobility or reduce the need for additional surgeries compared to traditional methods. The Verasense sensor aims to enhance knee replacement results by focusing on precise alignment and balance during surgery. The other group in this trial will receive standard of care TKA without the Verasense sensor. ^{2 4 6 7 8}

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

Ability to give informed consent

Varus alignment

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

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 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]

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]

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 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]

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]

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 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]

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 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36854996/

Verasense sensor-assisted total knee arthroplasty showed ... The use of Verasense pressure sensors in TKA leads to no significant improvement in ROM, reoperation rate or functional outcomes, when compared to the standard ...

2. trialx.com trialx.com/clinical-trials/listings/309431/balancing-kinematically-aligned-total-knee-replacements-during-total-primary-knee-arthroplasty-using-verasense/

Balancing Kinematically Aligned Total Knee Replacements ... The primary objective of this research study is to evaluate the use of the Verasense pressure sensor to optimize intraoperative implant pressures/balance during ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7948048/

Sensor-Assisted Total Knee Arthroplasty: A Narrative Review Recent studies using the sensors have demonstrated reductions in gap imbalance, as well as early improvement of patient-reported clinical outcomes and low rates ...

4. withpower.com withpower.com/trial/phase-osteoarthritis-2-2018-c7310

Knee Replacement Techniques for Osteoarthritis This study will evaluate the effectiveness of robot-assisted surgery (RAS) and kinematic alignment (KA) in total knee arthroplasty (TKA) compared to traditional ...

5. researchgate.net researchgate.net/publication/368889806_Verasense_sensor-assisted_total_knee_arthroplasty_showed_no_difference_in_range_of_motion_reoperation_rate_or_functional_outcomes_when_compared_to_manually_balanced_total_knee_arthroplasty_a_systemati

(PDF) Verasense sensor-assisted total knee arthroplasty ... In terms of clinical outcomes, the overwhelming majority of studies observed an improvement after VA TKA, but no statistically significant ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10090011/

Verasense sensor-assisted total knee arthroplasty showed ... The aim of this systematic review was to investigate the clinical and functional knee outcomes after Verasense sensor-assisted total knee arthroplasty (VA TKA)

7. esskajournals.onlinelibrary.wiley.com esskajournals.onlinelibrary.wiley.com/doi/pdf/10.1007/s00167-023-07352-9

Verasense sensor‑assisted total knee arthroplasty showed Conclusion The use of Verasense pressure sensors in TKA leads to no signiicant improvement in ROM, reoperation rate or functional outcomes, when ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2949705123000099

Review Alignment techniques in total knee arthroplasty Howell et al. reported that implant survival of 220 kinematic alignment TKAs using MRI-based PSI at 10 years of follow-up was 97.5% for revision for any reason ...