Osteoarthritis, KneeNCT04814082
Prospective Functional, Gait, and Outcome Comparison Study of Medial Pivot Versus Single Radius Design for Total Knee Arthroplasty
A study testing MicroPort Evolution Medial-Pivot Knee System (Cruciate-substituting) and Stryker Triathlon Tritanium Knee System (Condylar Stabilizing) in people with Osteoarthritis, Knee and Knee Osteoarthritis, run by LifeBridge Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteoarthritis, Knee, Knee Osteoarthritis, Osteoarthritis Knees Both
- What is being tested?
- MicroPort Evolution Medial-Pivot Knee System (Cruciate-substituting) and Stryker Triathlon Tritanium Knee System (Condylar Stabilizing)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 1 Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Martin Gesheff, mgesheff@lifebridgehealth.org
Nirav Patel, nirpatel@lifebridgehealth.org
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoarthritis, Knee, Knee Osteoarthritis, Osteoarthritis Knees Both, Osteoarthritis Knee Left, Osteoarthritis Knee Right, Knee Pain Chronic
- Being tested
- MicroPort Evolution Medial-Pivot Knee System (Cruciate-substituting), Stryker Triathlon Tritanium Knee System (Condylar Stabilizing)
- Keywords
- Total Knee Arthroplasty, Total Knee Replacement
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 group | Role | What they receive |
|---|---|---|
| Medial-Pivot Knee System | Active comparator | Total Knee Arthroplasty will be done by implanting the MicroPort Medial Pivot Knee System into subjects. Receives: 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. Receives: Device: Stryker Triathlon Tritanium Knee System (Condylar Stabilizing) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Pre-operative; Post-operative - 3 month and 12 month follow-up visit
Secondary outcomes (7)
Implant Survivorship
Radiographic assessment using AP and lateral knee X-rays to analyze implant position, radiolucencies, fracture, and osteolysis.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-operative; Post-operative - 6 week, 6 month, 12 month, 24 month, 36 month, and 60 month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start1 Feb 2021
- Primary completion1 Jul 2030 (estimated)
- Study completion1 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LifeBridge Health
- Sponsor type
- University, hospital or other
- Collaborators
- Rubin Institute for Advanced Orthopedics, MicroPort Orthopedics Inc.
- Responsible party
- Sponsor
- Investigators
- James Nace, MD, Principal investigator, LifeBridge Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04814082
- Sponsor's protocol ID
- 1679091
- Status last verified
- Jan 2025
- First submitted
- 3 Feb 2021
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Functional, Gait, and Outcome Comparison Study of Medial Pivot
- ClinicalTrials.gov ID
- NCT04814082
- Acronym / sponsor ID
- 1679091
- Conditions
- Osteoarthritis, Knee, Knee Osteoarthritis, Osteoarthritis Knees Both, Osteoarthritis Knee Left, Osteoarthritis Knee Right, Knee Pain Chronic
- Keywords
- Total Knee Arthroplasty, Total Knee Replacement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- LifeBridge HealthUniversity, hospital or other
- Collaborators
- Rubin Institute for Advanced Orthopedics, MicroPort Orthopedics Inc.
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Jul 2030 (estimated)
- Study completion
- 1 Jul 2030 (estimated)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medial-Pivot Knee System | Active comparator | Device: MicroPort Evolution Medial-Pivot Knee System (Cruciate-substituting)Total Knee Arthroplasty will be done by implanting the MicroPort Medial Pivot Knee System into subjects. |
| Single Radius Design Total Knee System | Active comparator | Device: Stryker Triathlon Tritanium Knee System (Condylar Stabilizing)Total Knee Arthroplasty will be done by implanting the Stryker Triathlon Tritanium Knee System into subjects. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MicroPort Evolution Medial-Pivot Knee System (Cruciate-substituting)Medial Pivot Knee System | Device | Medial-Pivot Knee System |
| Stryker Triathlon Tritanium Knee System (Condylar Stabilizing)Single Radius Design Total Knee System | Device | Single Radius Design Total Knee System |
Primary outcome
Change in Knee Mechanics
Time frame: Pre-operative; Post-operative - 3 month and 12 month follow-up visit
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
Time frame: Pre-operative; Post-operative - 3 month and 12 month follow-up visit
This parameter will be measured (in mm) and analyzed using the KneeKG system during incline and decline walking.
Change in Initial Peak Loading Force
Time frame: Pre-operative; Post-operative - 3 month and 12 month follow-up visit
This parameter will be measured (in N) and analyzed using the KneeKG system during normal walking.
Change in Active and Passive Range of Motion
Time frame: Pre-operative; Post-operative - 3 month and 12 month follow-up visit
Active and passive range of motion will be measured (in degrees) using a goniometer.
Change in Quadriceps Lag
Time frame: Pre-operative; Post-operative - 3 month and 12 month follow-up visit
Quadriceps lag will be measured (in degrees) in both the sitting and supine positions.
Change in Timed up and Go Test (TUG)
Time frame: Pre-operative; Post-operative - 3 month and 12 month follow-up visit
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
Time frame: Pre-operative; Post-operative - 3 month and 12 month follow-up visit
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
Time frame: Pre-operative; Post-operative - 3 month and 12 month follow-up visit
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
Time frame: Pre-operative; Post-operative - 3 month and 12 month follow-up visit
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
Time frame: Pre-operative; Post-operative - 3 month and 12 month follow-up visit
This parameter will be measured (in lbs/in) using a dynamometer for quadricep muscle strength assessment.
7 secondary outcomes
Implant Survivorship
Time frame: Post-operative - 6 week, 6 month, 12 month, 24 month, 36 month, and 60 month follow-up visit
Post-surgical Complications
Time frame: Operative visit; Post-operative - 6 week, 6 month, 12 month, 24 month, 36 month, and 60 month follow-up visit
Evidence of Osteolysis
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: Pre-operative; Post-operative - 6 week, 6 month, 12 month, 24 month, 36 month, and 60 month follow-up visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James Nace, MD principal investigator
LifeBridge Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MicroPort Evolution Medial-Pivot Knee System (Cruciate-substituting) and Stryker Triathlon Tritanium Knee System (Condylar Stabilizing) in people with Osteoarthritis, Knee and Knee Osteoarthritis, run by LifeBridge Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin Gesheff (410-601-9467, mgesheff@lifebridgehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Knee Mechanics (time frame: Pre-operative; Post-operative - 3 month and 12 month follow-up visit). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.