OsteoarthritisNCT02290119
Gait and Functional Improvement in Total Knee Arthroplasty With the Use of Verasense for Soft Tissue Balancing
A study testing Sensor-assisted TKR (Verasense) in people with Osteoarthritis, run by Orthosensor, Inc. at 1 site in United States.
Trial summary
The primary objectives of this study are to understand the effects of soft-tissue balancing on Gait, function and rehabilitation potential after sensor-assisted Total Knee Arthroplasty and correlate Intra-operative subjective feel with OrthoSensor Outputs Secondary objectives are to quantify and observe: Pain… Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Sensor-assisted TKR (Verasense)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2018to 12 Oct 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 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject must be a candidate for a primary PCL retaining total knee arthroplasty
- Subject must be diagnosed with one or more of the following conditions: osteoarthritis, avascular necrosis, rheumatoid or other inflammatory arthritis, post-traumatic arthritis
- Subject is between the age of 45 - 80 years
- Subject is likely to be available for all study visits
- Subject is able and willing to sign the informed consent and follow study procedures
Who cannot join
- Prior total knee arthroplasty, ligament insufficiencies, prior surgeries such as ACL or PCL reconstructions, posterolateral reconstructions, osteotomies, tibia plateau fractures
- Range of Motion less than 90 degrees, flexion contracture of more than 20 degrees
Trial locations and contacts
1 site in 1 country.
United States1 site
Sinai Hospital of Baltimore - Rubin Institute of Advanced Orthopedics Center for Joint Preservation and Reconstruction
Baltimore, Maryland, 21215-5271
About this study
Official title: PILOT STUDY: Gait and Functional Improvement in Total Knee Arthroplasty With the Use of Verasense for Soft Tissue Balancing: A Randomized, Double-Blind, Controlled Trial
The primary objectives of this study are to understand the effects of soft-tissue balancing on Gait, function and rehabilitation potential after sensor-assisted Total Knee Arthroplasty and correlate Intra-operative subjective feel with OrthoSensor Outputs
Secondary objectives are to quantify and observe:
- Pain medication use
- Swelling
- Muscle strength and girth
- Gait efficiency
- Patient satisfaction
- Activity levels, functional return (i.e., back to work, resume normal activities)
- Patient perception of a balanced knee
- Conditions
- Osteoarthritis
- Being tested
- Sensor-assisted TKR (Verasense), Control - Without the use of Verasense
- Keywords
- Primary PCL-retaining Total Knee Arthroplasty, Intraoperative Sensors, Ligament Balancing, Clinical Outcomes
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensor-assisted TKR (Verasense)Device
Verasense is a single use, disposable device embedded with microelectronics into a standard tibial trial to provide dynamic, intraoperative feedback regarding limb alignment, tibiofemoral position and quantitative pressure at peak contact points in the medial and lateral compartments during total knee replacement surgery. Utilizing sensor-derived data, the surgeon can now evaluate intercompartmental loading throughout the range of motion, and correct for soft-tissue abnormalities while receiving real-time feedback regarding joint balance.
Control - Without the use of VerasenseProcedure or surgery
Patients in this cohort will undergo manual total knee replacement without the use of Verasense
| Study group | Role | What they receive |
|---|---|---|
| Control - Without the use of Verasense | Sham comparator | Total Knee Replacement without the use of intraoperative sensors Receives: Procedure: Control - Without the use of Verasense |
| Sensor-assisted TKR (Verasense) | Active comparator | Total Knee Replacement with the use of intraoperative sensors Receives: Device: Sensor-assisted TKR (Verasense) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rehabilitation Potential
Measured: 6 Months
Secondary outcomes (3)
Knee Society Pain and Functional Scoring (KSS)
The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome.
Measured: 6 month
Forgotten Joint Score (FJS)
The FJS is based on the patients' ability to forget about a joint as a result of the treatment. The FJS assessment is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities.
Measured: 6 month
3D Gait Analysis velocity
3D gait analysis relates to the range of motion of a joint and the movement velocity. The mean gait speed analysis is considered higher than 1 m/s.
Measured: 6 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2014 (estimated)
- Study start1 Apr 2018
- Primary completion12 Oct 2022
- Study completion12 Oct 2022
Why it stopped: as a result of Orthosensor's acquisition by Stryker in July 2018.No final mutually agreed (signed) protocol was found and no clear records of the study data can be retrieved. No accurate and reliable results of this study can be posted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orthosensor, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ron Delanois, MD, Principal investigator, Sinai Hospital of Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02290119
- Sponsor's protocol ID
- 101
- Status last verified
- Feb 2023
- First submitted
- 31 Oct 2014
- Last updated
- 6 Feb 2023
- 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 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PILOT STUDY: Gait and Functional Improvement in Total Knee Arthroplasty With the Use of Verasense for Soft Tissue Balancing: A Randomized, Double-Blind, Controlled Trial
- ClinicalTrials.gov ID
- NCT02290119
- Acronym / sponsor ID
- 101
- Conditions
- Osteoarthritis
- Keywords
- Primary PCL-retaining Total Knee Arthroplasty, Intraoperative Sensors, Ligament Balancing, Clinical Outcomes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: as a result of Orthosensor's acquisition by Stryker in July 2018.No final mutually agreed (signed) protocol was found and no clear records of the study data can be retrieved. No accurate and reliable results of this study can be posted.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Orthosensor, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 12 Oct 2022 (actual)
- Study completion
- 12 Oct 2022 (actual)
- First posted
- 13 Nov 2014 (estimated)
- 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 primary objectives of this study are to understand the effects of soft-tissue balancing on Gait, function and rehabilitation potential after sensor-assisted Total Knee Arthroplasty and correlate Intra-operative subjective feel with OrthoSensor Outputs
Secondary objectives are to quantify and observe:
- Pain medication use
- Swelling
- Muscle strength and girth
- Gait efficiency
- Patient satisfaction
- Activity levels, functional return (i.e., back to work, resume normal activities)
- Patient perception of a balanced knee
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control - Without the use of Verasense | Sham comparator | Procedure: Control - Without the use of VerasenseTotal Knee Replacement without the use of intraoperative sensors |
| Sensor-assisted TKR (Verasense) | Active comparator | Device: Sensor-assisted TKR (Verasense)Total Knee Replacement with the use of intraoperative sensors |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject must be a candidate for a primary PCL retaining total knee arthroplasty
- Subject must be diagnosed with one or more of the following conditions: osteoarthritis, avascular necrosis, rheumatoid or other inflammatory arthritis, post-traumatic arthritis
- Subject is between the age of 45 - 80 years
- Subject is likely to be available for all study visits
- Subject is able and willing to sign the informed consent and follow study procedures
Key exclusion criteria (2 listed)
- Prior total knee arthroplasty, ligament insufficiencies, prior surgeries such as ACL or PCL reconstructions, posterolateral reconstructions, osteotomies, tibia plateau fractures
- Range of Motion less than 90 degrees, flexion contracture of more than 20 degrees
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 |
|---|---|---|
| Sensor-assisted TKR (Verasense)Verasense is a single use, disposable device embedded with microelectronics into a standard tibial trial to provide dynamic, intraoperative feedback regarding limb alignment, tibiofemoral position and quantitative pressure at peak contact points in the medial and lateral compartments during total knee replacement surgery. Utilizing sensor-derived data, the surgeon can now evaluate intercompartmental loading throughout the range of motion, and correct for soft-tissue abnormalities while receiving real-time feedback regarding joint balance. | Device | Sensor-assisted TKR (Verasense) |
| Control - Without the use of VerasensePatients in this cohort will undergo manual total knee replacement without the use of Verasense | Procedure or surgery | Control - Without the use of Verasense |
Primary outcome
Rehabilitation Potential
Time frame: 6 Months
3 secondary outcomes
Knee Society Pain and Functional Scoring (KSS)
Time frame: 6 month
Forgotten Joint Score (FJS)
Time frame: 6 month
3D Gait Analysis velocity
Time frame: 6 Month
Results and safety
The study was stopped early (reason given: as a result of Orthosensor's acquisition by Stryker in July 2018.No final mutually agreed (signed) protocol was found and no clear records of the study data can be retrieved. No accurate and reliable results of this study can be posted.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
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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. This study is not recruiting at the moment.
Ron Delanois, MD principal investigator
Sinai Hospital of Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensor-assisted TKR (Verasense) in people with Osteoarthritis, run by Orthosensor, Inc. 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 5 inclusion and 2 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: stopped early, as of the sponsor's last update on 6 Feb 2023. 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. Some participants in this study may receive a placebo. 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?
The study was stopped early (reason given: as a result of Orthosensor's acquisition by Stryker in July 2018.No final mutually agreed (signed) protocol was found and no clear records of the study data can be retrieved. No accurate and reliable results of this study can be posted.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rehabilitation Potential (time frame: 6 Months). 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 Feb 2023.