MedTrace Logo

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

NCT04814082 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-01-22

No results posted yet for this 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

  • Osteoarthritis, Knee
  • Knee Osteoarthritis
  • Osteoarthritis Knees Both
  • Osteoarthritis Knee Left
  • Osteoarthritis Knee Right
  • Knee Pain Chronic
  • Knee Disease
  • Arthropathy of Knee Joint

Interventions

DEVICE

MicroPort Evolution Medial-Pivot Knee System (Cruciate-substituting)

Medial Pivot Knee System

DEVICE

Stryker Triathlon Tritanium Knee System (Condylar Stabilizing)

Single Radius Design Total Knee System

Sponsors & Collaborators

  • Rubin Institute for Advanced Orthopedics

    collaborator UNKNOWN

  • MicroPort Orthopedics Inc.

    collaborator INDUSTRY

  • LifeBridge Health

    lead OTHER

Principal Investigators

  • James Nace, MD · LifeBridge Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2030-07-01
Completion
2030-07-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04814082 on ClinicalTrials.gov