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

Prospective Functional, Gait, and Outcome Comparison Study of Medial Pivot

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.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis; Osteoarthritis, Knee; Knee Pain Chronic; Arthropathy of Knee Joint; Knee Disease; Osteoarthritis Knees Both; Osteoarthritis Knee Left; Osteoarthritis Knee Right
• Intervention / Treatment: Device: MicroPort Evolution Medial-Pivot Knee System (Cruciate-substituting); Device: Stryker Triathlon Tritanium Knee System (Condylar Stabilizing)

Detailed Description

This is a single center, cohort study in 100 adult subjects undergoing primary total knee arthroplasty that will receive one of the two total knee device systems.

Primary total knee replacement is an effective treatment for relieving pain and improving function for patients with degenerative joint disease. Recently, design of knee implants in a total knee replacement have received increased interest, particularly the medial pivot designs. Single-radius implants are designed to minimize instability throughout the functional range of movement. Medial pivot total knee designs theoretically recreate more normal knee motion when compared to single radius designs. Both implant designs are commonly used for total knee replacements. Outcomes of TKA are evaluated by multiple methods including implant/device survivorship, radiographic assessments, clinical examinations, and patient reported outcome measures (PROMS). Laboratory based gait analysis performed at a specialized research facility is not commonly conducted in patients with positive outcomes post-surgery as this is associated with high cost. There is currently not enough research comparing these two designs directly. Research is required to determine which design may provide better clinical outcomes and satisfaction with the procedure.

In addition to your normal standard clinical care, there will be scheduled pre-operative, operative, 6-week, 6 month, 12 month, 24 month, 36 month, and 60 month follow-up visits.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Martin Gesheff; Phone Number: 410-601-9467; Email: mgesheff@lifebridgehealth.org
• Study Contact Backup: Name: Nirav Patel; Phone Number: 410-601-8860; Email: nirpatel@lifebridgehealth.org

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21215
      • Recruiting
      • Sinai Hospital of Baltimore
      • Contact: Nirav Patel; Email: nirpatel@lifebridgehealth.org
      • Contact: Martin Gesheff; Email: mgesheff@lifebridgehealth.org
      • Contact: James Nace, DO
      • Contact: Ronald Delanois, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Medial-Pivot Knee System; Total Knee Arthroplasty will be done by implanting the MicroPort Medial Pivot Knee System into subjects.	Device: MicroPort Evolution Medial-Pivot Knee System (Cruciate-substituting); Medial Pivot Knee System
Active Comparator: Single Radius Design Total Knee System; Total Knee Arthroplasty will be done by implanting the Stryker Triathlon Tritanium Knee System into subjects.	Device: Stryker Triathlon Tritanium Knee System (Condylar Stabilizing); Single Radius Design Total Knee System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Knee Mechanics	Knee flexion/extension, varus/valgus, and internal/external rotation will be measured (in degrees) and analyzed using the KneeKG system during incline and decline walking.	Pre-operative; Post-operative - 3 month and 12 month follow-up visit
Change in Anterior/Posterior Knee Translation	This parameter will be measured (in mm) and analyzed using the KneeKG system during incline and decline walking.	Pre-operative; Post-operative - 3 month and 12 month follow-up visit
Change in Initial Peak Loading Force	This parameter will be measured (in N) and analyzed using the KneeKG system during normal walking.	Pre-operative; Post-operative - 3 month and 12 month follow-up visit
Change in Active and Passive Range of Motion	Active and passive range of motion will be measured (in degrees) using a goniometer.	Pre-operative; Post-operative - 3 month and 12 month follow-up visit
Change in Quadriceps Lag	Quadriceps lag will be measured (in degrees) in both the sitting and supine positions.	Pre-operative; Post-operative - 3 month and 12 month follow-up visit
Change in Timed up and Go Test (TUG)	This parameter will be measured in seconds and requires a patient to rise from a chair walk three meters and return to the chair again as quickly as possible.	Pre-operative; Post-operative - 3 month and 12 month follow-up visit
Change in Five Times Sit to Stand Test	This parameter will be measured in seconds and will collect the amount of time it takes a patient to transfer from a seated to a standing position and back to sitting five times.	Pre-operative; Post-operative - 3 month and 12 month follow-up visit
Change in Single Limb Stance Test for Both Knees	This parameter will be measured in seconds and will collect the amount of time a patient is able to stand unassisted on one leg.	Pre-operative; Post-operative - 3 month and 12 month follow-up visit
Change in Timed Ascent and Descent of One Flight of Stairs Test	This parameter will be measured in seconds and will collect the amount of time it takes a patient to ascend and descend one flight of stairs (8-14 steps).	Pre-operative; Post-operative - 3 month and 12 month follow-up visit
Change in Quadriceps Muscle Strength	This parameter will be measured (in lbs/in) using a dynamometer for quadricep muscle strength assessment.	Pre-operative; Post-operative - 3 month and 12 month follow-up visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant Survivorship	Radiographic assessment using AP and lateral knee X-rays to analyze implant position, radiolucencies, fracture, and osteolysis.	Post-operative - 6 week, 6 month, 12 month, 24 month, 36 month, and 60 month follow-up visit
Post-surgical Complications	All complications related to the procedure will be documented.	Operative visit; Post-operative - 6 week, 6 month, 12 month, 24 month, 36 month, and 60 month follow-up visit
Evidence of Osteolysis	X-rays will be evaluated to look for presence of a radiolucent area, especially > 2mm, around implant or cement with sclerotic border.	Pre-operative; Post-operative - 6 week, 6 month, 12 month, 24 month, 36 month, and 60 month follow-up visit
Change in Knee Society Score (KSS) Short Form	25 question items assessing symptoms, patient satisfaction, patient expectation, and their level of functional activity of their knee. Scores range from 0-100 with higher scores representing better outcomes.	Pre-operative; Post-operative - 6 week, 6 month, 12 month, 24 month, 36 month, and 60 month follow-up visit
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)	42 question items assessing a patient's opinion about their health, symptoms, and function of their knee. Scores range from 0-100 with zero representing severe knee problems and 100 indicating no knee problems.	Pre-operative; Post-operative - 6 week, 6 month, 12 month, 24 month, 36 month, and 60 month follow-up visit
Change in Patient Reported Outcomes Measurement Information System (PROMIS-10)	10 question items assessing overall physical, mental, and social health of the patient. Each question item is scored separately on 1-5 scale and total scores are combined into 2 groups - Global Physical Health Score and Global Mental Health score. A T-score is calculated with the 2 previous scores against the general population with a higher T-score representing better outcomes.	Pre-operative; Post-operative - 6 week, 6 month, 12 month, 24 month, 36 month, and 60 month follow-up visit
Change in Forgotten Joint Score FJS	12 question items evaluating how "aware" a patient is of their operative joint during daily activities. Scores range between 0-100 with higher scores indicating a patient is able to forget the joint on a daily basis or low joint awareness.	Pre-operative; Post-operative - 6 week, 6 month, 12 month, 24 month, 36 month, and 60 month follow-up visit

Collaborators and Investigators

• Sponsor: LifeBridge Health
• Collaborators: MicroPort Orthopedics Inc.; Rubin Institute for Advanced Orthopedics
• Investigators: Principal Investigator: James Nace, MD, LifeBridge Health

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2030

Study Registration Dates

• First Submitted: February 3, 2021
• First Submitted That Met QC Criteria: March 22, 2021
• First Posted (Actual): March 24, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 20, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Total Knee Arthroplasty; Total Knee Replacement
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 1679091

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes