Surgical Alignments for Knee Arthritis

Recruiting in Palo Alto (17 mi)

Overseen by Adam Edelstein, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Northwestern University

Must not be taking: Opioids

Disqualifiers: Inflammatory arthritis, Chronic pain, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Knee replacement surgery can be performed in one of two ways. Traditionally the goal was for the new joint to be in a neutral position with respect to the femur (thigh bone). This is called Mechanical Alignment (MA). The neutral position is different than the human knee's natural position, so MA often requires the surgeon to make additional cuts to the ligaments and other soft tissue around the knee. More recently surgeons have started to place the new joint in a position that more closely replicates the natural alignment of the human knee. This is called Kinemetic Alignment (KA). KA can be done without additional soft tissue dissection but the procedure requires a higher level of precision that can be difficult to achieve in every case. Some studies have found no difference in outcomes between MA and KA, whereas others have found KA to be superior. But these were small studies or studies that did not consider patient-rated outcomes.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are using chronic opioids, you may not be eligible to participate.

What data supports the effectiveness of the treatment Kinematic Alignment for knee arthritis?

Research shows that kinematic alignment, which aims to match the knee's natural anatomy, may improve functional outcomes in knee replacement surgery compared to traditional mechanical alignment. However, results are mixed, and the best approach may depend on individual patient characteristics.

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Is kinematic alignment safe for knee surgery?

Research comparing kinematic alignment to mechanical alignment in knee surgery shows that both methods are generally safe for patients. Studies have focused on outcomes like implant survival and clinical results, indicating no major safety concerns with kinematic alignment.

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How does the kinematic alignment treatment for knee arthritis differ from other treatments?

Kinematic alignment (KA) is a unique surgical technique for knee arthritis that aims to align the knee replacement components to match the patient's natural knee anatomy, potentially improving function. This differs from mechanical alignment (MA), which positions components based on a standard neutral alignment, not tailored to individual anatomy.

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Eligibility Criteria

This trial is for individuals with knee osteoarthritis needing replacement surgery. It's comparing two surgical methods: traditional Mechanical Alignment (MA) and the newer Kinematic Alignment (KA). Suitable participants should not have conditions that may interfere with the surgery or recovery.

Inclusion Criteria

I am having a knee replacement with a specific type of knee system.

Able to read and understand consent form and PRO instruments and willing to return for follow up visits

Exclusion Criteria

Patients receiving workers' compensation for study condition

I am unable to understand or sign the consent form.

My study knee has had an infection.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Total Knee Arthroplasty (TKA) using either Mechanical Alignment (MA) or Kinematic Alignment (KA) methodology

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of KOOS-JR score

6 weeks

1 visit (in-person)

Long-term Follow-up

Participants are assessed for long-term outcomes, including the Forgotten Joint Score (FJS)

1 year

Participant Groups

The study tests whether aligning the new knee joint to mimic natural anatomy (KA) has better outcomes than aligning it in a neutral position (MA). The focus is on patient-rated results, addressing gaps in previous research.

Group I: Mechanical Alignment (MA) Active Control 1 Intervention

Primary TKA with the Medacta SpheriKA, utilizing either MA methodology.

Group II: Kinematic Alignment (KA) Active Control 1 Intervention

Primary TKA with the Medacta SpheriKA, utilizing either KA methodology.

Kinematic Alignment is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺 Approved in European Union as Kinematic Alignment for:

• Total Knee Arthroplasty
• Knee Replacement Surgery

🇺🇸 Approved in United States as Kinematic Alignment for:

• Total Knee Arthroplasty
• Knee Replacement Surgery

🇨🇦 Approved in Canada as Kinematic Alignment for:

• Total Knee Arthroplasty
• Knee Replacement Surgery

🇯🇵 Approved in Japan as Kinematic Alignment for:

• Total Knee Arthroplasty
• Knee Replacement Surgery

🇨🇳 Approved in China as Kinematic Alignment for:

• Total Knee Arthroplasty
• Knee Replacement Surgery

🇨🇭 Approved in Switzerland as Kinematic Alignment for:

• Total Knee Arthroplasty
• Knee Replacement Surgery

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Northwestern Medicine Chicago, IL

Who Is Running the Clinical Trial?

Northwestern University Lead Sponsor

Medacta International SA Industry Sponsor

References

1. Japan pubmed.ncbi.nlm.nih.gov

Kinematic and mechanical alignments in total knee arthroplasty: A meta-analysis with ≥1-year follow-up. [2023] Kinematic and mechanical alignment outcomes in total knee arthroplasty remain controversial. This study compared the clinical and radiological outcomes of total knee arthroplasty using kinematic and mechanical alignments.

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] 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.

3. Germany pubmed.ncbi.nlm.nih.gov

Outcome of kinematic alignment using patient-specific instrumentation versus mechanical alignment in TKA: a meta-analysis and subgroup analysis of randomised trials. [2018] Kinematic alignment (KA) in total knee arthroplasty (TKA) matches component position to the pre-arthritic anatomy of an individual patient, with the aim of improving functional outcomes. Recent randomised controlled trials (RCTs) comparing KA to traditional neutral mechanical alignment (MA) have been mixed. This collaborative study combined raw data from RCTs, aiming to compare functional outcomes between KA using patient-specific instrumentation (PSI) and MA, and whether any patient subgroups may benefit more from KA technique.

4. England pubmed.ncbi.nlm.nih.gov

How to choose kinematic or mechanical alignment individually according to preoperative characteristics of patients? [2021] Making decisions in alignment techniques in total knee arthroplasty (TKA) remains controversial. This study aims to identify the potential patients who were suitable for the kinematic (KA) or mechanical alignment (MA).

5. England pubmed.ncbi.nlm.nih.gov

Kinematic alignment versus mechanical alignment in primary total knee arthroplasty: an updated meta-analysis of randomized controlled trials. [2022] The purpose of this study was to perform an updated meta-analysis to compare the outcomes of kinematic alignment (KA) and mechanical alignment (MA) in patients undergoing total knee arthroplasty.

6. Germany pubmed.ncbi.nlm.nih.gov

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.

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

The Impact of Mechanical and Restricted Kinematic Alignment on Knee Anatomy in Total Knee Arthroplasty. [2018] Total knee arthroplasty (TKA), aiming at neutral mechanical alignment (MA), inevitably modifies the patient's native knee anatomy. Another option is kinematic alignment (KA), which aims to restore the original anatomy of the knee. The aim of this study was to evaluate the variations in lower limb anatomy of a patient population scheduled for TKA, and to assess the use of a restricted KA TKA protocol and compare the resulting anatomic modifications with the standard MA technique.

8. 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] 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.

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

The Chitranjan S. Ranawat Award : No Difference in 2-year Functional Outcomes Using Kinematic versus Mechanical Alignment in TKA: A Randomized Controlled Clinical Trial. [2022] Neutral mechanical alignment (MA) in total knee arthroplasty (TKA) aims to position femoral and tibial components perpendicular to the mechanical axis of the limb. In contrast, kinematic alignment (KA) attempts to match implant position to the prearthritic anatomy of the individual patient with the aim of improving functional outcome. However, comparative data between the two techniques are lacking.

10. Switzerland 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. [2023] The kinematic alignment technique, as one of the alignment options for total knee arthroplasty, has attracted increasing attention from orthopedic surgeons and has been increasingly performed in the most populous countries in the world. The purpose of this study is to explore and compare the early clinical outcomes of total knee arthroplasty with KA using specific instruments vs. mechanical alignment in our nation.

11. Germany pubmed.ncbi.nlm.nih.gov

Influence of kinematic alignment on femorotibial kinematics in medial stabilized TKA design compared to mechanical alignment. [2023] Worldwide more and more primary knee replacements are being performed. Kinematic alignment (KA) as one of many methods of surgical alignment has been shown to have a significant impact on kinematics and function. The aim of the present study was to compare KA and mechanical alignment (MA) with regard to femorotibial kinematics.