Northwestern Medicine
Chicago, Illinois, 60611, United States
Location status: Recruiting
Location contact
Megan VanDyke, BSN
CONTACT
Melissa Shauver, MPH
CONTACT
NCT Number: NCT06617871
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.
Interested in participating?
Request Info21 year–79 year
All sexes
Interventional
Not applicable
Chicago, Illinois, 60611, United States
Location status: Recruiting
Megan VanDyke, BSN
CONTACT
Melissa Shauver, MPH
CONTACT
Up to 20% of patients that report dissatisfaction and chronic pain following Total knee arthroplasty (TKA). Prior research has identified patient demographic, comorbidity, and expectations as factors that are associated with dissatisfaction. Emerging literature has also suggested that surgical factors including component alignment, soft tissue balance, and kinematics may play a role in patient satisfaction, and that modifications to alignment may result in better function than performing soft tissue releases. Personalized alignment strategies have been proposed that aim to more closely recreate native knee morphology and kinematics. Kinematic alignment (KA) describes a technique that aims to restore the pre-arthritic joint surfaces and alignment of the femur and tibia by removing the bone and cartilage thickness that will be replaced by the implant, taking into account cartilage wear. KA can therefore be conceptualized as a resurfacing procedure, wherein native joint surfaces are replaced by prosthetic surfaces but the position and alignment of the joint surfaces are not changed. This contrasts with mechanical alignment (MA), in which implants are positioned perpendicular to the mechanical axes of the femur and tibia in a manner independent of the pre-arthritic joint surfaces, and soft tissue releases are performed to bring limb alignment into mechanical neutral.
There have been prior randomized trials comparing kinematic and mechanical alignment, and these have had mixed results regarding the superiority of one approach over the other. The majority of these trials did not use the same operative modality for both groups (manual vs computer-assisted techniques) or did not include relevant patient reported outcomes (PROs). There is a need for a prospective, randomized trial comparing outcomes following kinematic vs mechanical alignment TKA, with the same operative modality used in both groups with inclusion of relevant PROs.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Primary TKA with the Medacta SpheriKA, utilizing either MA methodology.
Primary TKA with the Medacta SpheriKA, utilizing either KA methodology.
Time frame: 6 weeks postoperative
The Knee Injury and Osteoarthritis Score - Joint Replacement (KOOS-JR) score; range: 0 (worst knee health) - 100 (perfect knee health)
Time frame: 1 year postoperative
Forgotten Joint Score (FJS) questionnaire score; range: 0 (worst outcome) - 100 (best outcome)
Contact information is provided by the study sponsor or research team.
Megan VanDyke, BSN
CONTACT
Melissa Shauver, MPH
CONTACT
Northwestern University
Other
A Prospective, Randomized, Single-blinded Clinical Trial Comparing Mechanical Alignment vs Kalipered Kinematic Alignment Total Knee Arthroplasty Using Medacta Spherika
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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