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Prospective Functional, Gait, and Outcome Comparison Study of Medial Pivot Versus Single Radius Design for Total Knee Arthroplasty

RecruitingNot applicableNCT04814082
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Prospective Functional, Gait, and Outcome Comparison Study of Medial Pivot
Conditions
Interventions
  • Device: MicroPort Evolution Medial-Pivot Knee System (Cruciate-substituting)
  • Device: Stryker Triathlon Tritanium Knee System (Condylar Stabilizing)
Sponsor
LifeBridge Health
Collaborators
Rubin Institute for Advanced Orthopedics; MicroPort Orthopedics Inc.
Start date
2021-02-01
Primary completion
2030-07-01
Sex
All
Age range
from 18 Years to 75 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04814082