NCT04814082 Prospective Functional, Gait, and Outcome Comparison Study of Medial Pivot Versus Single Radius Design for Total Knee Arthroplasty
| NCT ID | NCT04814082 |
| Status | Recruiting |
| Phase | — |
| Sponsor | LifeBridge Health |
| Condition | Osteoarthritis, Knee |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2021-02-01 |
| Primary Completion | 2030-07-01 |
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 100 participants in total. It began in 2021-02-01 with a primary completion date of 2030-07-01.
⚠ 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
Patients with degenerative joint disease can effectively be treated with a primary total knee replacement to reduce pain and improve function in their daily lives. Theoretically, achievement of normal knee motion using a medial pivot design in total knee replacements can be recreated in comparison to single radius designs, which could lead to an improvement in post-surgical outcomes and satisfaction with the procedure. The aim of this study is to compare two types of implant designs (medial pivot and single radius) in a total knee replacement using clinical outcomes, patient reported outcomes, and overall function assessed by a specialized gait laboratory.
Eligibility Criteria
Inclusion Criteria: * Subject is male or non-pregnant female aged between 18 and 75 years of age. * Subject is willing to provide informed consent to participate in the research study. * Subject is indicated for a primary total knee arthroplasty (TKA) based on the approved labeling of knee implant, either a medial pivot or single radius design, specifically: MicroPort Evolution Medial-Pivot Knee System, Cruciate Retaining (CS) or Stryker Triathlon Tritanium (CS) * Subject does not have a history of previous prosthetic replacement device on the operative knee. * Subject is currently ambulating and does not have a condition on the contralateral limb in the opinion of the investigator that would interfere with the gait laboratory evaluations. * Subject is willing and able to comply with the schedule of events for the study and is available to return to the clinic for all required follow-up visits. Exclusion Criteria: * Subject has a Body Mass Index (BMI) \>40 * Subject has a diagnosis of avascular necrosis or inflammatory arthritis. * Subject has any mental or neuromuscular disorder that would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care. * Subject is a prisoner * Subject has any condition, in the opinion of the Investigator that might interfere with the evaluation of the study objectives.
Contact & Investigator
James Nace, MD
PRINCIPAL INVESTIGATOR
LifeBridge Health
Frequently Asked Questions
Who can join the NCT04814082 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Osteoarthritis, Knee. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04814082 currently recruiting?
Yes, NCT04814082 is actively recruiting participants. Contact the research team at mgesheff@lifebridgehealth.org for enrollment information.
Where is the NCT04814082 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT04814082 clinical trial?
NCT04814082 is sponsored by LifeBridge Health. The principal investigator is James Nace, MD at LifeBridge Health. The trial plans to enroll 100 participants.