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

NCT04814082 | Recruiting FDA Device

• 1 other identifier: 1679091
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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; Knee Pain Chronic; Knee Disease; Arthropathy of Knee Joint

Keywords

Total Knee Arthroplasty; Total Knee Replacement

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (7)

• Implant Survivorship

  Post-operative - 6 week, 6 month, 12 month, 24 month, 36 month, and 60 month follow-up visit

• Post-surgical Complications

  Operative visit; Post-operative - 6 week, 6 month, 12 month, 24 month, 36 month, and 60 month follow-up visit

• Evidence of Osteolysis

  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

  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)

  Pre-operative; Post-operative - 6 week, 6 month, 12 month, 24 month, 36 month, and 60 month follow-up visit

Study Arms (2)

Medial-Pivot Knee System

ACTIVE COMPARATOR

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)

Single Radius Design Total Knee System

ACTIVE COMPARATOR

Total Knee Arthroplasty will be done by implanting the Stryker Triathlon Tritanium Knee System into subjects.

Device: Stryker Triathlon Tritanium Knee System (Condylar Stabilizing)

Interventions

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

Medial Pivot Knee System

Medial-Pivot Knee System

Stryker Triathlon Tritanium Knee System (Condylar Stabilizing) DEVICE

Single Radius Design Total Knee System

Single Radius Design Total Knee System

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LifeBridge Health: lead
• Rubin Institute for Advanced Orthopedics: collaborator
• MicroPort Orthopedics Inc.: collaborator

Study Sites (1)

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• James Nace, MD

  LifeBridge Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Gesheff

CONTACT

410-601-9467; mgesheff@lifebridgehealth.org

Nirav Patel

CONTACT

410-601-8860; nirpatel@lifebridgehealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: March 24, 2021
• Study Start: February 1, 2021
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: January 22, 2025

Record last verified: 2025-01

Locations

US (1)