NCT06617871 Mechanical Alignment vs Kalipered Kinematic Alignment Total Knee Arthroplasty
| NCT ID | NCT06617871 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Northwestern University |
| Condition | Knee Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 95 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 95 participants in total. It began in 2024-08-01 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Patient undergoing primary TKA with a medially-stabilized SpheriKA knee system * Able to read and understand consent form and PRO instruments and willing to return for follow up visits Exclusion Criteria: * Varus or Valgus malalignment \>15 degrees to mechanical axis * Flexion contracture \>15 degrees or flexion \<90 degrees * BMI \>40 * Revision TKA or other prior knee surgery other than arthroscopy or arthroscopic-assisted ligament reconstruction * Diagnosis or history of any of the following * inflammatory arthritis * infection in study knee * chronic pain * chronic opioid use * metabolic musculoskeletal disorder other than osteopenia/osteoporosis * Patients receiving workers' compensation for study condition * Patients who cannot complete questionnaires in English * Patients with comorbidities preventing surgery * Patients who are not able to provide informed consent
Contact & Investigator
Adam Edelstein, MD
PRINCIPAL INVESTIGATOR
Assistant Professor of Orthopaedic Surgery
Frequently Asked Questions
Who can join the NCT06617871 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 79 Years, studying Knee Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06617871 currently recruiting?
Yes, NCT06617871 is actively recruiting participants. Contact the research team at melissa.shauver@northwestern.edu for enrollment information.
Where is the NCT06617871 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT06617871 clinical trial?
NCT06617871 is sponsored by Northwestern University. The principal investigator is Adam Edelstein, MD at Assistant Professor of Orthopaedic Surgery. The trial plans to enroll 95 participants.