Recruiting

Medial Pivot vs. Single Radius

Sponsor:

LifeBridge Health

Code:

NCT04814082

Conditions

Osteoarthritis, Knee

Knee Osteoarthritis

Osteoarthritis Knees Both

Osteoarthritis Knee Left

Osteoarthritis Knee Right

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

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

Stryker Triathlon Tritanium Knee System (Condylar Stabilizing)

Study Details

Brief 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

Study ID

NCT04814082

Start date

Feb 1, 2021

Status verified date

Jan, 2025

Completion date

Jul 1, 2030

Anticipated

Primary completion date

Jul 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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

Medial Pivot Knee System

Stryker Triathlon Tritanium Knee System (Condylar Stabilizing)

Single Radius Design Total Knee System

Primary outcome measure

  • Change in Knee Mechanics [ Time Frame: Pre-operative; Post-operative - 3 month and 12 month follow-up visit ]
  • Change in Anterior/Posterior Knee Translation [ Time Frame: Pre-operative; Post-operative - 3 month and 12 month follow-up visit ]
  • Change in Initial Peak Loading Force [ Time Frame: Pre-operative; Post-operative - 3 month and 12 month follow-up visit ]
  • Change in Active and Passive Range of Motion [ Time Frame: Pre-operative; Post-operative - 3 month and 12 month follow-up visit ]
  • Change in Quadriceps Lag [ Time Frame: Pre-operative; Post-operative - 3 month and 12 month follow-up visit ]
  • Change in Timed up and Go Test (TUG) [ Time Frame: Pre-operative; Post-operative - 3 month and 12 month follow-up visit ]
  • Change in Five Times Sit to Stand Test [ Time Frame: Pre-operative; Post-operative - 3 month and 12 month follow-up visit ]
  • Change in Single Limb Stance Test for Both Knees [ Time Frame: Pre-operative; Post-operative - 3 month and 12 month follow-up visit ]
  • Change in Timed Ascent and Descent of One Flight of Stairs Test [ Time Frame: Pre-operative; Post-operative - 3 month and 12 month follow-up visit ]
  • Change in Quadriceps Muscle Strength [ Time Frame: Pre-operative; Post-operative - 3 month and 12 month follow-up visit ]

Central Contacts and Locations

Central contacts

Martin Gesheff

410-601-9467mgesheff@lifebridgehealth.org

Nirav Patel

410-601-8860nirpatel@lifebridgehealth.org

Locations

Sinai Hospital of Baltimore

Recruiting

Baltimore, Maryland, United States, 21215

Contacts

Martin Gesheff

mgesheff@lifebridgehealth.org

Nirav Patel

nirpatel@lifebridgehealth.org

Principal Investigator:

James Nace, DO

More Information

Sponsor

LifeBridge Health

Last update posted

Jan 22, 2025

Last verified

Jan, 2025

Keywords

  • Total Knee Arthroplasty
  • Total Knee Replacement

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by LifeBridge Health on 2025-01-22.