Knee OsteoarthritisNCT04163445
Comparison of TKAs Using Force Plate Analysis
A study testing MicroPort Orthopedics EVOLUTION Medial Pivot TKA and Depuy Synthes ATTUNE PCR TKA in people with Knee Osteoarthritis and Total Knee Arthroplasty, run by Russell Nevins, M.D. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate performance of two modern total knee arthroplasty designs using patient reported outcomes and force exhibited during various activities of daily living. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis, Total Knee Arthroplasty, Knee Injuries
- What is being tested?
- MicroPort Orthopedics EVOLUTION Medial Pivot TKA and Depuy Synthes ATTUNE PCR TKA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2020to Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who have been appropriately designated for treatment with a primary total knee arthroplasty
- Subjects who are willing to participate and are willing to sign the Informed Consent/HIPPA documents.
Who cannot join
- Subjects who are unsuitable candidates for the two types of knee implants under investigation.
- Subjects with significant deformities or arthritis that might affect the procedural decision making, expected outcomes and functions are total knee arthroplasty.
- Subjects with significant comorbidities that might be at an increased risk of post-operative complications.
- Subjects who are unwilling to sign Informed Consent/HIPAA documents.
- Subjects who cannot perform the required activities after the surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Desert Orthopaedic Center
Las Vegas, Nevada, 89121
Russell Nevins, MD, 702-731-1616, russellnevinsmd@gmail.com
About this study
Official title: Comparison of Different TKAs Using Objective Dynamic Functional Analysis
The purpose of this study is to evaluate performance of two modern total knee arthroplasty designs using patient reported outcomes and force exhibited during various activities of daily living.
Read the detailed description
48 patients with primary osteoarthritis of the knee who have been appropriately designated for treatment with a total knee arthroplasty (TKA) will be randomly assigned to one of two groups; one group (24 patients) will receive a Depuy Attune PCR knee implant, and one group (24 patients) will receive a MicroPort Orthopedics Evolution Medial Pivot knee implant utilizing standard and modern techniques. These two implants are designed to recreate the kinematic motion of a native knee articulation using different biomechanical design philosophies.
The patients will be monitored post-operatively using subjective and objective measures. Subjective patient reported outcomes will be analyzed using the Knee Injury and Osteoarthritis Outcome Score (KOOS), recorded preoperatively, as well as at 6 weeks, and 3 months postoperatively. Objective outcomes will be measured by having the patients perform four activities over force plates that will measure the amount of force a patient generates. The four activities will be: walking, standing from a seated position in a chair, squatting to a seated position, and walking up stairs. These objective measures will also be recorded preoperatively, 6 weeks, and 3 months postoperatively. The patient reported outcomes and the objective measures will then be compared between the two groups.
- Being tested
- MicroPort Orthopedics EVOLUTION Medial Pivot TKA, Depuy Synthes ATTUNE PCR TKA
- Medical subject headings
- Osteoarthritis, Knee, Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroPort Orthopedics EVOLUTION Medial Pivot TKADevice
Subjects will have been implanted with the Microport Evolution Medial Pivot TKA
Depuy Synthes ATTUNE PCR TKADevice
Subjects will have been implanted with the Depuy Attune PCR TKA
| Study group | Role | What they receive |
|---|---|---|
| Depuy Attune | Active comparator | Subjects will have been implanted with the Depuy Attune PCR TKA Receives: Device: Depuy Synthes ATTUNE PCR TKA |
| MicroPort Medial Pivot | Active comparator | Subjects will have been implanted with the Microport Evolution Medial Pivot TKA Receives: Device: MicroPort Orthopedics EVOLUTION Medial Pivot TKA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Injury and Osteoarthritis Outcome Score
KOOS Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms
Measured: pre-operatively
Knee Injury and Osteoarthritis Outcome Score
KOOS Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms
Measured: 6 weeks post-operatively
Knee Injury and Osteoarthritis Outcome Score
KOOS Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms
Measured: 3 months post-operatively
Force generated by operative extremity - walking
Distribution of maximum force between implanted and non- implanted leg during walking
Measured: pre-operatively
Force generated by operative extremity - walking
Distribution of maximum force between implanted and non- implanted leg during walking
Measured: 6 weeks post-operatively
Force generated by operative extremity - walking
Distribution of maximum force between implanted and non- implanted leg during walking
Measured: 3 months post-operatively
Force generated by operative extremity - standing from seated position
Distribution of maximum force between implanted and non- implanted leg during standing from a seated position in a chair
Measured: pre-operatively
Force generated by operative extremity - standing from seated position
Distribution of maximum force between implanted and non- implanted leg during standing from a seated position in a chair
Measured: 6 weeks post-operatively
Force generated by operative extremity - standing from seated position
Distribution of maximum force between implanted and non- implanted leg during standing from a seated position in a chair
Measured: 3 months post-operatively
Force generated by operative extremity - squatting to a seated position
Distribution of maximum force between implanted and non- implanted leg during squatting to a seated position
Measured: pre-operatively
Force generated by operative extremity - squatting to a seated position
Distribution of maximum force between implanted and non- implanted leg during squatting to a seated position
Measured: 6 weeks post-operatively
Force generated by operative extremity - squatting to a seated position
Distribution of maximum force between implanted and non- implanted leg during squatting to a seated position
Measured: 3 months post-operatively
Force generated by operative extremity - walking up stairs
Distribution of maximum force between implanted and non- implanted leg during walking up stairs
Measured: pre-operatively
Force generated by operative extremity - walking up stairs
Distribution of maximum force between implanted and non- implanted leg during walking up stairs
Measured: 6 weeks post-operatively
Force generated by operative extremity - walking up stairs
Distribution of maximum force between implanted and non- implanted leg during walking up stairs
Measured: 3 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start11 Nov 2020
- Primary completionNov 2021 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Russell Nevins, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- MicroPort Orthopedics Inc.
- Responsible party
- Sponsor-investigator, Russell Nevins, M.D., Desert Orthopedic Center
- Investigators
- Russell Nevins, Principal investigator, Desert Orthopedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04163445
- Sponsor's protocol ID
- 17IISK01 0
- Status last verified
- Jul 2021
- First submitted
- 6 Nov 2019
- Last updated
- 6 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different TKAs Using Objective Dynamic Functional Analysis
- ClinicalTrials.gov ID
- NCT04163445
- Acronym / sponsor ID
- 17IISK01 0
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Russell Nevins, M.D.University, hospital or other
- Collaborators
- MicroPort Orthopedics Inc.
- Study start
- 11 Nov 2020 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 14 Nov 2019 (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.
The purpose of this study is to evaluate performance of two modern total knee arthroplasty designs using patient reported outcomes and force exhibited during various activities of daily living.
Detailed description
48 patients with primary osteoarthritis of the knee who have been appropriately designated for treatment with a total knee arthroplasty (TKA) will be randomly assigned to one of two groups; one group (24 patients) will receive a Depuy Attune PCR knee implant, and one group (24 patients) will receive a MicroPort Orthopedics Evolution Medial Pivot knee implant utilizing standard and modern techniques. These two implants are designed to recreate the kinematic motion of a native knee articulation using different biomechanical design philosophies.
The patients will be monitored post-operatively using subjective and objective measures. Subjective patient reported outcomes will be analyzed using the Knee Injury and Osteoarthritis Outcome Score (KOOS), recorded preoperatively, as well as at 6 weeks, and 3 months postoperatively. Objective outcomes will be measured by having the patients perform four activities over force plates that will measure the amount of force a patient generates. The four activities will be: walking, standing from a seated position in a chair, squatting to a seated position, and walking up stairs. These objective measures will also be recorded preoperatively, 6 weeks, and 3 months postoperatively. The patient reported outcomes and the objective measures will then be compared between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Depuy Attune | Active comparator | Device: Depuy Synthes ATTUNE PCR TKASubjects will have been implanted with the Depuy Attune PCR TKA |
| MicroPort Medial Pivot | Active comparator | Device: MicroPort Orthopedics EVOLUTION Medial Pivot TKASubjects will have been implanted with the Microport Evolution Medial Pivot TKA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects who have been appropriately designated for treatment with a primary total knee arthroplasty
- Subjects who are willing to participate and are willing to sign the Informed Consent/HIPPA documents.
Key exclusion criteria (5 listed)
- Subjects who are unsuitable candidates for the two types of knee implants under investigation.
- Subjects with significant deformities or arthritis that might affect the procedural decision making, expected outcomes and functions are total knee arthroplasty.
- Subjects with significant comorbidities that might be at an increased risk of post-operative complications.
- Subjects who are unwilling to sign Informed Consent/HIPAA documents.
- Subjects who cannot perform the required activities after the surgery.
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 Orthopedics EVOLUTION Medial Pivot TKASubjects will have been implanted with the Microport Evolution Medial Pivot TKA | Device | MicroPort Medial Pivot |
| Depuy Synthes ATTUNE PCR TKASubjects will have been implanted with the Depuy Attune PCR TKA | Device | Depuy Attune |
Primary outcome
Knee Injury and Osteoarthritis Outcome Score
Time frame: pre-operatively
KOOS Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms
Knee Injury and Osteoarthritis Outcome Score
Time frame: 6 weeks post-operatively
KOOS Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms
Knee Injury and Osteoarthritis Outcome Score
Time frame: 3 months post-operatively
KOOS Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms
Force generated by operative extremity - walking
Time frame: pre-operatively
Distribution of maximum force between implanted and non- implanted leg during walking
Force generated by operative extremity - walking
Time frame: 6 weeks post-operatively
Distribution of maximum force between implanted and non- implanted leg during walking
Force generated by operative extremity - walking
Time frame: 3 months post-operatively
Distribution of maximum force between implanted and non- implanted leg during walking
Force generated by operative extremity - standing from seated position
Time frame: pre-operatively
Distribution of maximum force between implanted and non- implanted leg during standing from a seated position in a chair
Force generated by operative extremity - standing from seated position
Time frame: 6 weeks post-operatively
Distribution of maximum force between implanted and non- implanted leg during standing from a seated position in a chair
Force generated by operative extremity - standing from seated position
Time frame: 3 months post-operatively
Distribution of maximum force between implanted and non- implanted leg during standing from a seated position in a chair
Force generated by operative extremity - squatting to a seated position
Time frame: pre-operatively
Distribution of maximum force between implanted and non- implanted leg during squatting to a seated position
Force generated by operative extremity - squatting to a seated position
Time frame: 6 weeks post-operatively
Distribution of maximum force between implanted and non- implanted leg during squatting to a seated position
Force generated by operative extremity - squatting to a seated position
Time frame: 3 months post-operatively
Distribution of maximum force between implanted and non- implanted leg during squatting to a seated position
Force generated by operative extremity - walking up stairs
Time frame: pre-operatively
Distribution of maximum force between implanted and non- implanted leg during walking up stairs
Force generated by operative extremity - walking up stairs
Time frame: 6 weeks post-operatively
Distribution of maximum force between implanted and non- implanted leg during walking up stairs
Force generated by operative extremity - walking up stairs
Time frame: 3 months post-operatively
Distribution of maximum force between implanted and non- implanted leg during walking up stairs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
Not yet recruiting
Study Comparing Osteoarthritis Programs
Osteoarthritis
Recruiting
Daily Knee Sleeve Use Versus No Use in Older Adults With Chronic Knee Pain
Knee Arthritis, Osteoarthritis
RecruitingObservational study
SVF Cellular Composition, Secretome, and Responses in Knee Osteoarthritis
Osteoarthritis, Knee
Recruiting
Pharmacist-physiotherapist Collaborative Management for Early Knee Osteoarthritis
Osteoarthritis (OA) of the Knee, Physiotherapy
Recruiting
Outpatient Physiotherapy vs. mHealth Exercise and Self-Management for Knee Osteoarthritis (MOKneeTOR)
Knee Osteoarthristis
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. This study is not recruiting at the moment.
Russell Nevins principal investigator
Desert Orthopedics
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 Orthopedics EVOLUTION Medial Pivot TKA and Depuy Synthes ATTUNE PCR TKA in people with Knee Osteoarthritis and Total Knee Arthroplasty, run by Russell Nevins, M.D. 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 2 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: status not confirmed, as of the sponsor's last update on 6 Aug 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Russell Nevins, MD (702-731-1616, russellnevinsmd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Injury and Osteoarthritis Outcome Score (time frame: pre-operatively). The study lists 15 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 6 Aug 2021.