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Prospective Functional, Gait, and Outcome Comparison Study of Medial Pivot Versus Single Radius Design for Total Knee Arthroplasty
NCT04814082 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DEVICE MicroPort Evolution Medial-Pivot Knee System (Cruciate-substituting)
- DEVICE Stryker Triathlon Tritanium Knee System (Condylar Stabilizing)
Study Locations (1)
Maryland
- Sinai Hospital of Baltimore — Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2021-02-01 |
| Est. Completion | 2030-07-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04814082
The ClinicalTrials.gov registry entry for NCT04814082 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is LifeBridge Health, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 8 conditions, with Knee Osteoarthritis appearing as the primary indexed condition, and to 2 interventions — of which MicroPort Evolution Medial-Pivot Knee System (Cruciate-substituting) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04814082 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04814082 about?
NCT04814082 is a clinical study titled "Prospective Functional, Gait, and Outcome Comparison Study of Medial Pivot Versus Single Radius Design for Total Knee Arthroplasty". 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 t...
What is the current status of trial NCT04814082?
This trial is currently recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2021-02-01. Estimated completion is 2030-07-01.
What conditions does trial NCT04814082 study?
This clinical trial studies the following conditions: Knee Osteoarthritis, Osteoarthritis, Knee, Knee Pain Chronic, Knee Disease, Arthropathy of Knee Joint. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04814082?
The interventions under investigation include: MicroPort Evolution Medial-Pivot Knee System (Cruciate-substituting) (DEVICE), Stryker Triathlon Tritanium Knee System (Condylar Stabilizing) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04814082?
This trial is sponsored by LifeBridge Health, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04814082 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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