Two knee replacement designs compared for people with knee osteoarthritis
Compares two knee implant designs in adults having knee replacement for osteoarthritis.
Key facts
- Who runs it
- LifeBridge Health
- Where
- Baltimore, United StatesSee the site
- Trial code
- Registry title
- Prospective Functional, Gait, and Outcome Comparison Study of Medial Pivot Versus Single Radius Design for Total Knee Arthroplasty
- Status
- Recruiting
- People taking part
- 100 people, planned
- Started
- 1 Feb 2021
- Expected to end
- 1 Jul 2030
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- MicroPort Evolution Medial-Pivot Knee System (Cruciate-substituting)
- Stryker Triathlon Tritanium Knee System (Condylar Stabilizing)
- Record updated
- 22 January 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with knee joint wear (osteoarthritis) who are due for a first total knee replacement. It compares two knee implant designs.
- Age
- 18 to 75 years
- Sex
- Men, and women who are not pregnant
- Disease stage
- Knee joint disease where a first (primary) total knee replacement is planned. People must be able to walk now.
- Earlier treatment
- People cannot join if they already had an artificial joint put in the knee being operated on.
Main reasons for not taking part
- Body Mass Index (BMI) >40
- Avascular necrosis (bone death from poor blood supply) or inflammatory arthritis
- A mental or nerve-muscle disorder that makes the new knee or recovery too risky
- A problem in the other leg that would affect walking tests
- Being a prisoner
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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 has any condition, in the opinion of the Investigator that might interfere with the evaluation of the study objectives
- Subject has a Body Mass Index (BMI) >40
- Subject has a diagnosis of avascular necrosis or inflammatory arthritis
- Subject is a prisoner
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in United States
- Sinai Hospital of BaltimoreBaltimore, United StatesContact: Martin GesheffTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Medial-Pivot Knee SystemExisting treatment, for comparison
Total Knee Arthroplasty will be done by implanting the MicroPort Medial Pivot Knee System into subjects.
Treatment: MicroPort Evolution Medial-Pivot Knee System (Cruciate-substituting)
- Single Radius Design Total Knee SystemExisting treatment, for comparison
Total Knee Arthroplasty will be done by implanting the Stryker Triathlon Tritanium Knee System into subjects.
Treatment: Stryker Triathlon Tritanium Knee System (Condylar Stabilizing)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Prospective Functional, Gait, and Outcome Comparison Study of Medial Pivot
- Plain-language title
- Two knee replacement designs compared for people with knee osteoarthritisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Fit questions
- Built from NCT04814082, who can take part
- Record updated
- 22 January 2025