Knee Replacement Techniques for Osteoarthritis

(KMART Trial)

Overseen By Kim Madden, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: McMaster University

Disqualifiers: Cognitive disability, Language barrier, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 1 week

260 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two methods of knee replacement surgery for individuals with painful knee arthritis. The traditional approach, known as Mechanically-Aligned Arthroplasty, aims to make the knee perfectly straight. The newer technique, called Restricted Kinematically-aligned Arthroplasty, customizes the knee replacement to fit each person’s unique knee shape. The researchers aim to determine which method feels more natural and improves knee function more effectively. Participants will have knee arthritis, require total knee replacement surgery, and will receive surgery assisted by a robot for precise placement. As a Phase 4 trial, this research involves FDA-approved treatments and seeks to understand how these methods benefit more patients.

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 is the safety track record for these knee replacement techniques?

Studies have shown that restricted kinematic alignment, a personalized method for knee replacement, is safe and well-tolerated by patients. A review of six studies involving 444 patients found no increase in complications for those who underwent this surgery compared to the traditional method. Research indicates that both techniques are about equally safe in the short to mid-term.

However, restricted kinematic alignment lacks long-term data, so researchers are still learning about its performance over many years. Current evidence suggests it is a reliable option for knee replacement surgery. Participants in this study will undergo robot-assisted surgery, which ensures accurate and safe implant placement. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study?

Researchers are excited about these knee replacement techniques for osteoarthritis because they offer innovative approaches to joint alignment. Unlike the standard mechanical alignment, which aims for a fixed alignment relative to the mechanical axis, the restricted kinematic alignment technique strives to more closely mimic the natural movement of the knee. This method could potentially improve patient comfort and joint function by preserving more of the natural knee kinematics. By comparing these methods, researchers hope to determine which technique provides better outcomes for individuals suffering from osteoarthritis.

What evidence suggests that this trial's knee replacement techniques could be effective for osteoarthritis?

This trial will compare two knee replacement techniques for osteoarthritis: Mechanically-Aligned Arthroplasty and Restricted Kinematically-Aligned Arthroplasty. Research has shown that kinematic alignment in knee replacements might lead to slightly better results than the traditional method. A review of several studies suggests that patients may experience improved knee function with the kinematic approach. Additionally, studies indicate that patients report higher satisfaction and better movement with this method. Importantly, there is no significant increase in failure rates, which bodes well for long-term success. These findings suggest that aligning the knee to match each person's natural shape may result in a more comfortable and functional joint. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with painful knee arthritis who are candidates for total knee replacement surgery. Participants will be those interested in a robot-assisted procedure and willing to undergo motion capture assessments and complete questionnaires before and after the operation at specified intervals.

Inclusion Criteria

I need a knee replacement due to arthritis.

Provide informed consent

Exclusion Criteria

Inability to obtain a CT scan prior to surgery

I have had knee surgery before.

Inability or unwillingness to comply with the study protocol

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Assessment

Participants undergo preoperative assessment including walking in a markerless motion capture system to measure walking characteristics

1-2 weeks

1 visit (in-person)

Treatment

Participants receive a robot-assisted total knee replacement using either mechanical alignment or restricted kinematic alignment

1 week

1 visit (in-person)

Postoperative Follow-up

Participants complete standardized questionnaires and undergo assessments at 6, 12, and 24 months post-operation to monitor outcomes such as gait biomechanics, quality of life, and knee function

24 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Mechanically-Aligned Arthroplasty
• Restricted Kinematically-aligned Arthroplasty

Trial Overview The study compares two techniques of knee replacement: traditional mechanical alignment aiming for a straight knee, versus restricted kinematic alignment tailored to individual's unique knee shape. Both methods use robotic assistance for precise implant placement, assessing which results in better patient outcomes.

How Is the Trial Designed?

Group I: Restricted Kinematic Alignment Experimental Treatment 1 Intervention

Group II: Mechanical Alignment Active Control 1 Intervention

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Canadian Orthopaedic Foundation (funding)

Collaborator

Trials

2

Recruited

310+

Research Institute of St. Joseph's Hamilton

Collaborator

Trials

2

Recruited

700,000+

Published Research Related to This Trial

Kinematic alignment (KA) in knee replacement surgery resulted in more internal rotation of the tibia and a larger medial rotation point compared to mechanical alignment (MA), suggesting improved knee joint mechanics.

The study, which tested eight fresh frozen human knee specimens during active flexion, indicates that KA combined with a medial stabilized implant may better replicate natural knee movement during bending.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of kinematic alignment on femorotibial kinematics in medial stabilized TKA design compared to mechanical alignment. Bauer, L., Woiczinski, M., Thorwächter, C., et al.[2023]

Kinematic alignment in total knee arthroplasty resulted in better knee joint function scores and improved flexion angles compared to mechanical alignment, based on a meta-analysis of 19 studies involving 1845 total knee arthroplasties.

Despite the differences in functional outcomes, both kinematic and mechanical alignments showed similar overall clinical outcomes and complication rates, suggesting that kinematic alignment can be a safe and effective option for knee surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kinematic and mechanical alignments in total knee arthroplasty: A meta-analysis with ≥1-year follow-up. Wang, G., Chen, L., Xu, J.[2023]

In a study of 126 patients undergoing total knee arthroplasty, those who received kinematic alignment (KA-TKA) showed significantly better clinical outcomes, including higher knee joint clinical scores and functional scores, compared to those who received mechanical alignment (MA-TKA) at both 3 months and 2 years post-surgery.

Both KA-TKA and MA-TKA resulted in similar lower limb alignment after surgery, indicating that while KA-TKA may enhance clinical performance and patient satisfaction, it does not compromise alignment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An early clinical comparative study on total knee arthroplasty with kinematic alignment using specific instruments versus mechanical alignment in varus knees. Wen, L., Wang, Z., Ma, D., et al.[2023]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12231638/

Clinical outcomes of restricted kinematic alignment versus ... This meta-analysis aims to evaluate the clinical efficacy of rKA compared to mechanical alignment (MA) in TKA.

2. orthopedicreviews.openmedicalpublishing.org orthopedicreviews.openmedicalpublishing.org/article/122318-systematic-review-and-meta-analysis-of-long-term-outcomes-and-innovations-in-total-knee-arthroplasty-kinematic-personalized-knee-vs-conventional

Systematic review and meta-analysis of long term ... Although kinematic alignment showed slightly better clinical outcomes than mechanical alignment, the difference between the two techniques is ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0972978X25003940

Clinical differences in Patient Reported Outcome Measures ... While UKA has historically shown superior functional outcomes compared to mechanically aligned TKA, the emergence of KA TKA may challenge this ...

4. cureus.com cureus.com/articles/370341-improved-functional-outcomes-with-no-failures-three-years-after-calipered-restricted-kinematic-alignment-total-knee-arthroplasty-in-japanese-patients.pdf?email=

Improved Functional Outcomes With No Failures Three ... Here, we aim to evaluate the effectiveness and safety of CrKA-TKA (calipered restricted kinematic alignment-total knee arthroplasty) in.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06709703

Kinematic Alignment in Total Knee Arthroplasty The goal of this study is to learn if robotic assisted surgery is better than traditional method for knee replacement done using kinematic alignment. The main ...

6. cureus.com cureus.com/articles/424876-functional-outcomes-and-patient-satisfaction-in-kinematic-vs-mechanical-alignment-total-knee-arthroplasty-a-systematic-review

Functional Outcomes and Patient Satisfaction in Kinematic ... Abstract. Total knee arthroplasty (TKA) is a standard treatment for end-stage osteoarthritis, yet up to 20% of patients remain dissatisfied.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06726993

Study Details | NCT06726993 | Comparison of Restricted ... The restricted kinematic alignment is founded on five principles: hip-knee-ankle angle should be maintained within ± 3° postoperatively; a limitation to a ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0968016023002077

Restricted kinematic alignment is clinically non-inferior to ... rKA is a safe and reproducible method for performing total knee replacement in the short to mid-term. rKA lacks adequate data with extended follow up to define ...