Osteoarthritis, KneeNCT05006274
Intraoperative Soft Tissue Balance in TKA
An observational study of Osteoarthritis, Knee, run by Washington Hospital Healthcare System at 1 site in United States.
Trial summary
The purpose of this evaluation is to evaluate the intraoperative soft tissue balance as assessed by the Orthosensor device, to measure the perioperative gait and function with the Muvr tracking device, and to correlate this soft tissue balance with early functional outcomes in the Persona total knee system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Persona Trabecular Metal Tibia, Verasense technology and MUVR
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2021to Dec 2023
- Phase
- Observational
- 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
Study population: Healthy individuals having elective primary knee replacement
Who may be able to join
- Patient has a primary indication of osteoarthritis and is eligible for primary total knee arthroplasty using the Persona total knee system
- Patient is willing and able to provide written Informed Consent prior to study surgery
- Patient is willing and able to complete scheduled study procedures and follow-up evaluations as described in the Informed Consent Form
Who cannot join
- Patient does not have a primary indication of osteoarthritis
- Patient does not have access to internet or mobile device or understand how to use phone/app
- Patient is not eligible or will not receive the Persona total knee system
- Patient has not provided written Informed Consent
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Washington Hospital
Fremont, California, 94538
Alexander Sah, MD, 510-818-7200
About this study
Official title: Evaluation of Intraoperative Soft-tissue Balance and Postoperative Functional Recovery After Total Knee Arthroplasty
The purpose of this evaluation is to evaluate the intraoperative soft tissue balance as assessed by the Orthosensor device, to measure the perioperative gait and function with the Muvr tracking device, and to correlate this soft tissue balance with early functional outcomes in the Persona total knee system.
Read the detailed description
This is a single surgeon, prospective, controlled study consisting of 50 patients with a primary indication of OA who are eligible for primary total knee arthroplasty using the Persona total knee system.
The patients are equally divided in two groups; patients in group 1 will receive traditional, manual soft-tissue balancing during surgery. For the purpose of the study, the balance will be quantitatively assessed at the end of the case, by means of surgeon-blinded VERASENSE measurements before and after cementation. For the patients in Group 2, intra-operative sensor feedback will be used in creating a quantitatively balanced knee (VERASENSE, OrthoSensor Inc.). Thereby, a quantitatively balanced knee is characterized by a mediolateral load differential below 15lbs at 10-45-90 degrees of flexion.
Post-operatively, the patients will be evaluated using the Muvr device at the day of surgery, day of discharge and 2, 6, and 12 weeks, and 1 year postoperatively. This device will provide quantitative feedback on different gait metrics as well as function during activities of daily living such as stair climbing / stair descent, walking, and timed get up and go testing.
During each post-operative visit, the following metrics will be recorded:
- Active and passive range of motion
- Implant alignment
- Patient reported outcomes by means of Knee Society Score (KSS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Forgotten Joint Score (FJS)
- Conditions
- Osteoarthritis, Knee
- Being tested
- Persona Trabecular Metal Tibia, Verasense technology, MUVR
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Persona Trabecular Metal TibiaDevice
Total knee arthroplasty
Verasense technologyDevice
Instrumented tibial trial component
MUVRDevice
Knee motion and gait sensing wearable device
| Study group | Role | What they receive |
|---|---|---|
| Group 1-Traditional soft tissue balance | Patients in group 1 will receive traditional, manual soft-tissue balancing during surgery. For the purpose of the study, the balance will be quantitatively assessed at the end of the case, by means of surgeon-blinded VERASENSE measurements before and after cementation. Receives: Device: Persona Trabecular Metal Tibia; Device: Verasense technology; Device: MUVR | |
| Group 2-Soft tissue balance using VERASENSE | For the patients in Group 2, intra-operative sensor feedback will be used in creating a quantitatively balanced knee (VERASENSE, OrthoSensor Inc.). Thereby, a quantitatively balanced knee is characterized by a mediolateral load differential below 15lbs at 10-45-90 degrees of flexion. Receives: Device: Persona Trabecular Metal Tibia; Device: Verasense technology; Device: MUVR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active and passive range of motion
Flexion and extension measurements of knee
Measured: 2 weeks
Active and passive range of motion
Flexion and extension measurements of knee
Measured: 6 weeks
Active and passive range of motion
Flexion and extension measurements of knee
Measured: 12 weeks
Active and passive range of motion
Flexion and extension measurements of knee
Measured: 1 year
Implant alignment
Radiographic assessments
Measured: 2 weeks post-operatively
Implant alignment
Radiographic assessments
Measured: 6 weeks post-operatively
Implant alignment
Radiographic assessments
Measured: 12 weeks post-operatively
Implant alignment
Radiographic assessments
Measured: 1 year post-operatively
Knee Society Score (KSS)
Patient-reported outcome surveys assessing pain and function after total knee arthroplasty. Range 0-100, higher score better.
Measured: 2 weeks post-operatively
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Patient-reported outcome surveys assessing pain and function after total knee arthroplasty. Range 0-96, lower score means less disability
Measured: 2 weeks post-operatively
Forgotten Joint Score (FJS)
Patient-reported outcome surveys assessing pain and function after total knee arthroplasty. Range 0-100, 100 being better score
Measured: 2 weeks post-operatively
Knee Society Score (KSS)
Patient-reported outcome surveys assessing pain and function after total knee arthroplasty. Range 0-100, higher score better.
Measured: 12 weeks post-operatively
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Patient-reported outcome surveys assessing pain and function after total knee arthroplasty. Range 0-96, lower score means less disability
Measured: 12 weeks post-operatively
Forgotten Joint Score (FJS)
Patient-reported outcome surveys assessing pain and function after total knee arthroplasty. Range 0-100, 100 being better score
Measured: 12 weeks post-operatively
Knee Society Score (KSS)
Patient-reported outcome surveys assessing pain and function after total knee arthroplasty. Range 0-100, higher score better.
Measured: 52 weeks post-operatively
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Patient-reported outcome surveys assessing pain and function after total knee arthroplasty. Range 0-96, lower score means less disability
Measured: 52 weeks post-operatively
Forgotten Joint Score (FJS)
Patient-reported outcome surveys assessing pain and function after total knee arthroplasty. Range 0-100, 100 being better score
Measured: 52 weeks post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start13 Aug 2021
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington Hospital Healthcare System
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Biomet
- Responsible party
- Principal investigator, Alexander Sah, MD, Washington Hospital Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05006274
- Sponsor's protocol ID
- IRU2018-51K
- Status last verified
- Aug 2021
- First submitted
- 21 Jul 2021
- Last updated
- 19 Aug 2021
- Results posted
- No
- Data monitoring committee
- 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 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Intraoperative Soft-tissue Balance and Postoperative Functional Recovery After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05006274
- Acronym / sponsor ID
- IRU2018-51K
- Conditions
- Osteoarthritis, Knee
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Washington Hospital Healthcare SystemUniversity, hospital or other
- Collaborators
- Zimmer Biomet
- Study start
- 13 Aug 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 16 Aug 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.
The purpose of this evaluation is to evaluate the intraoperative soft tissue balance as assessed by the Orthosensor device, to measure the perioperative gait and function with the Muvr tracking device, and to correlate this soft tissue balance with early functional outcomes in the Persona total knee system.
Detailed description
This is a single surgeon, prospective, controlled study consisting of 50 patients with a primary indication of OA who are eligible for primary total knee arthroplasty using the Persona total knee system.
The patients are equally divided in two groups; patients in group 1 will receive traditional, manual soft-tissue balancing during surgery. For the purpose of the study, the balance will be quantitatively assessed at the end of the case, by means of surgeon-blinded VERASENSE measurements before and after cementation. For the patients in Group 2, intra-operative sensor feedback will be used in creating a quantitatively balanced knee (VERASENSE, OrthoSensor Inc.). Thereby, a quantitatively balanced knee is characterized by a mediolateral load differential below 15lbs at 10-45-90 degrees of flexion.
Post-operatively, the patients will be evaluated using the Muvr device at the day of surgery, day of discharge and 2, 6, and 12 weeks, and 1 year postoperatively. This device will provide quantitative feedback on different gait metrics as well as function during activities of daily living such as stair climbing / stair descent, walking, and timed get up and go testing.
During each post-operative visit, the following metrics will be recorded:
- Active and passive range of motion
- Implant alignment
- Patient reported outcomes by means of Knee Society Score (KSS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Forgotten Joint Score (FJS)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1-Traditional soft tissue balance | – | Device: Persona Trabecular Metal Tibia, Device: Verasense technology, Device: MUVRPatients in group 1 will receive traditional, manual soft-tissue balancing during surgery. For the purpose of the study, the balance will be quantitatively assessed at the end of the case, by means of surgeon-blinded VERASENSE measurements before and after cementation. |
| Group 2-Soft tissue balance using VERASENSE | – | Device: Persona Trabecular Metal Tibia, Device: Verasense technology, Device: MUVRFor the patients in Group 2, intra-operative sensor feedback will be used in creating a quantitatively balanced knee (VERASENSE, OrthoSensor Inc.). Thereby, a quantitatively balanced knee is characterized by a mediolateral load differential below 15lbs at 10-45-90 degrees of flexion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy individuals having elective primary knee replacement
Key inclusion criteria (3 listed)
- Patient has a primary indication of osteoarthritis and is eligible for primary total knee arthroplasty using the Persona total knee system
- Patient is willing and able to provide written Informed Consent prior to study surgery
- Patient is willing and able to complete scheduled study procedures and follow-up evaluations as described in the Informed Consent Form
Key exclusion criteria (4 listed)
- Patient does not have a primary indication of osteoarthritis
- Patient does not have access to internet or mobile device or understand how to use phone/app
- Patient is not eligible or will not receive the Persona total knee system
- Patient has not provided written Informed Consent
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 |
|---|---|---|
| Persona Trabecular Metal TibiaTotal knee arthroplasty | Device | Group 1-Traditional soft tissue balance, Group 2-Soft tissue balance using VERASENSE |
| Verasense technologyInstrumented tibial trial component | Device | Group 1-Traditional soft tissue balance, Group 2-Soft tissue balance using VERASENSE |
| MUVRKnee motion and gait sensing wearable device | Device | Group 1-Traditional soft tissue balance, Group 2-Soft tissue balance using VERASENSE |
Primary outcome
Active and passive range of motion
Time frame: 2 weeks
Flexion and extension measurements of knee
Active and passive range of motion
Time frame: 6 weeks
Flexion and extension measurements of knee
Active and passive range of motion
Time frame: 12 weeks
Flexion and extension measurements of knee
Active and passive range of motion
Time frame: 1 year
Flexion and extension measurements of knee
Implant alignment
Time frame: 2 weeks post-operatively
Radiographic assessments
Implant alignment
Time frame: 6 weeks post-operatively
Radiographic assessments
Implant alignment
Time frame: 12 weeks post-operatively
Radiographic assessments
Implant alignment
Time frame: 1 year post-operatively
Radiographic assessments
Knee Society Score (KSS)
Time frame: 2 weeks post-operatively
Patient-reported outcome surveys assessing pain and function after total knee arthroplasty. Range 0-100, higher score better.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 2 weeks post-operatively
Patient-reported outcome surveys assessing pain and function after total knee arthroplasty. Range 0-96, lower score means less disability
Forgotten Joint Score (FJS)
Time frame: 2 weeks post-operatively
Patient-reported outcome surveys assessing pain and function after total knee arthroplasty. Range 0-100, 100 being better score
Knee Society Score (KSS)
Time frame: 12 weeks post-operatively
Patient-reported outcome surveys assessing pain and function after total knee arthroplasty. Range 0-100, higher score better.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 12 weeks post-operatively
Patient-reported outcome surveys assessing pain and function after total knee arthroplasty. Range 0-96, lower score means less disability
Forgotten Joint Score (FJS)
Time frame: 12 weeks post-operatively
Patient-reported outcome surveys assessing pain and function after total knee arthroplasty. Range 0-100, 100 being better score
Knee Society Score (KSS)
Time frame: 52 weeks post-operatively
Patient-reported outcome surveys assessing pain and function after total knee arthroplasty. Range 0-100, higher score better.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 52 weeks post-operatively
Patient-reported outcome surveys assessing pain and function after total knee arthroplasty. Range 0-96, lower score means less disability
Forgotten Joint Score (FJS)
Time frame: 52 weeks post-operatively
Patient-reported outcome surveys assessing pain and function after total knee arthroplasty. Range 0-100, 100 being better score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis, Knee
Recruiting
Outpatient Physiotherapy vs. mHealth Exercise and Self-Management for Knee Osteoarthritis (MOKneeTOR)
Knee Osteoarthristis
Not yet recruiting
Effects of Music During Walking on Pain and Muscle Activation in People With Chronic Pain Due to Knee Osteoarthritis
Knee Osteoarthritis
Recruiting
Radio- KO Radiotherapy for Knee Osteoarthritis Clinical Trial
Osteoarthritis, Knee
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Not yet recruiting
Effects of Low-Load Blood Flow Restriction Resistance Training With and Without Hip Abductor Strengthening in Patients With Knee Osteoarthritis.(BFR)
Knee Osteoarthritis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee, run by Washington Hospital Healthcare System 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 3 inclusion and 4 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 19 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 Alexander Sah, MD (510-818-7200, info@SahOrtho.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Active and passive range of motion (time frame: 2 weeks). The study lists 17 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 19 Aug 2021.