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

Primary Purpose

Osteoarthritis, Knee, Knee Osteoarthritis, Osteoarthritis Knees Both

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

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

Stryker Triathlon Tritanium Knee System (Condylar Stabilizing)

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Total Knee Arthroplasty, Total Knee Replacement

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sinai Hospital of BaltimoreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Medial-Pivot Knee System

Single Radius Design Total Knee System

Arm Description

Total Knee Arthroplasty will be done by implanting the MicroPort Medial Pivot Knee System into subjects.

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

Outcomes

Primary Outcome Measures

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.

Change in Anterior/Posterior Knee Translation

This parameter will be measured (in mm) and analyzed using the KneeKG system during incline and decline walking.

Change in Initial Peak Loading Force

This parameter will be measured (in N) and analyzed using the KneeKG system during normal walking.

Change in Active and Passive Range of Motion

Active and passive range of motion will be measured (in degrees) using a goniometer.

Change in Quadriceps Lag

Quadriceps lag will be measured (in degrees) in both the sitting and supine positions.

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.

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.

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.

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).

Change in Quadriceps Muscle Strength

This parameter will be measured (in lbs/in) using a dynamometer for quadricep muscle strength assessment.

Secondary Outcome Measures

Implant Survivorship

Radiographic assessment using AP and lateral knee X-rays to analyze implant position, radiolucencies, fracture, and osteolysis.

Post-surgical Complications

All complications related to the procedure will be documented.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT04814082

First Posted

February 3, 2021

Last Updated

April 14, 2022

Sponsor

LifeBridge Health

Collaborators

Rubin Institute for Advanced Orthopedics, MicroPort Orthopedics Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04814082

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 1, 2021 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

July 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

LifeBridge Health

Collaborators

Rubin Institute for Advanced Orthopedics, MicroPort Orthopedics Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Medial-Pivot Knee System

Arm Type

Active Comparator

Arm Description

Total Knee Arthroplasty will be done by implanting the MicroPort Medial Pivot Knee System into subjects.

Arm Title

Single Radius Design Total Knee System

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

Medial Pivot Knee System

Intervention Type

Device

Intervention Name(s)

Stryker Triathlon Tritanium Knee System (Condylar Stabilizing)

Intervention Description

Single Radius Design Total Knee System

Primary Outcome Measure Information:

Title

Change in Knee Mechanics

Description

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.

Time Frame