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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
LifeBridge Health
Study ID
NCT04814082
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • MicroPort Evolution Medial-Pivot Knee System (Cruciate-substituting) — DEVICE
    Medial Pivot Knee System
  • Stryker Triathlon Tritanium Knee System (Condylar Stabilizing) — DEVICE
    Single Radius Design Total Knee System

Study Details

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.

Key Dates

Start date
Feb 1, 2021
Status verified
Jan 2025
Primary completion
Jul 1, 2030
Completion
Jul 1, 2030

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Medial-Pivot Knee System
    Total Knee Arthroplasty will be done by implanting the MicroPort Medial Pivot Knee System into subjects.
  • Active Comparator: Single Radius Design Total Knee System
    Total Knee Arthroplasty will be done by implanting the Stryker Triathlon Tritanium Knee System into subjects.

Primary Outcome Measure

Change in Knee Mechanics [ Time Frame: Pre-operative; Post-operative - 3 month and 12 month follow-up visit ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Sinai Hospital of BaltimoreBaltimoreMaryland21215
Martin Gesheff
[email protected]
Nirav Patel
[email protected]
James Nace, DO (PRINCIPAL_INVESTIGATOR)
Ronald Delanois, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Baltimore, MD

By condition
Osteoarthritis (other)
By specialty
OrthopedicsMusculoskeletal disorders
By research site
Sinai Hospital of Baltimore· Baltimore, MD

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