Comparison of two knee implant designs for total knee replacement
Prospective Functional, Gait, and Outcome Comparison Study of Medial Pivot
This study is testing which of two different knee implant designs helps people who have knee replacement surgery feel better and be more satisfied afterward.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | LifeBridge Health Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT04814082 on ClinicalTrials.gov |
What this trial studies
This study compares the clinical outcomes and patient satisfaction between two types of knee implant designs used in total knee arthroplasty: the medial pivot design and the single radius design. It involves 100 adult participants who will undergo primary total knee replacement and will be assessed through various methods, including clinical evaluations and specialized gait analysis. The study aims to determine which implant design may lead to better functional outcomes and overall satisfaction post-surgery.
Who should consider this trial
Good fit: Ideal candidates are males or non-pregnant females aged 18 to 75 who require a primary total knee arthroplasty and meet specific health criteria.
Not a fit: Patients with a BMI over 40 or those with a history of previous knee prosthetic replacement will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and patient satisfaction for those undergoing total knee replacement.
How similar studies have performed: While there is limited direct research comparing these two designs, the study addresses a significant gap in existing literature and aims to provide valuable insights.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Baltimore, Maryland
- Sinai Hospital of Baltimore — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: James Nace, MD — LifeBridge Health
- Study coordinator: Martin Gesheff
- Email: mgesheff@lifebridgehealth.org
- Phone: 410-601-9467
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.