Osteo Arthritis KneeU-PropelNCT03060057
Prospective Post Approval Clinical Follow-Up Study of the Commercially Available U2 Knee™ System - "U-Propel Study"
An observational study of Osteo Arthritis Knee, run by United Orthopedic Corporation at 4 sites in United States.
Trial summary
The purpose of this study is to evaluate both short and long term clinical performance and safety of the commercially available U2 Knee™ System. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- U2 Knee™ System
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 4 sitesUnited States
- Study dates
- 30 Mar 2017to 30 Mar 2026
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The U2 Knee™ System is intended for use in subjects who require primary total knee arthroplasty for reduction or relief of pain and/or improved knee function.
Who may be able to join
- Subject is between 18 and 75 years of age
- Subject is indicated for a unilateral total knee arthroplasty (TKA) based on the approved labeling of the device
- Subject has no history of previous prosthetic replacement device or orthopedic surgeries on the operative knee
- Subject is willing and able to provide informed consent to participate in the study;
- Subject is willing and able to understand the purpose of the study, his/her role, and is available to return to the clinic/hospital for all required follow-up visits;
Who cannot join
- Subjects will be excluded if, in the opinion of the Investigator, the subject does not qualify based on approved labeling requirements or Subject Inclusion criteria.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Rubin Institute for Advanced Orthopedics
Baltimore, Maryland, 21215
Coastal Orthopedics
Bradenton, Florida, 34209
Jacksonville Orthopaedic Institute
Jacksonville, Florida, 32204
Orthopedic Center of Vero Beach
Vero Beach, Florida, 32960
About this study
The purpose of this study is to evaluate both short and long term clinical performance and safety of the commercially available U2 Knee™ System.
Read the detailed description
This is a prospective, single arm, multi-center, post-approval study designed to evaluate the short and long term clinical performance and safety in subjects receiving primary total knee arthroplasty (TKA) with the U2 Knee™ System. The study will enroll up to 200 subjects with scheduled pre-discharge, 6-week, 3- and 6-month and up to 5-year annual follow-up visits. Study outcomes will be analyzed and published when 1.) all enrolled and implanted subjects complete their 6-week follow up, 2.) all implanted subjects complete their 2-year follow up, 3.) at the conclusion of the study.
The study will follow GCP guidelines and will be registered on clinicaltrials.gov.
- Conditions
- Osteo Arthritis Knee
- Being tested
- U2 Knee™ System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
U2 Knee™ SystemDevice
The United U2 Knee™ System consists of several components and for this clinical evaluation it includes the (1) Femoral Component, (2) Tibial Insert, 3) Tibial Baseplate, and the 4) Patella.
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Survivorship
Device Survivorship defined as no revision of removal of any parts of the system
Measured: 2 Years
Secondary outcomes (7)
Change in Knee Society Score (KSS) Over Time
This endpoint is defined as differences in both pain and functional parameters measured at current and pre-discharge visits
Measured: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, 5 years
Change in EQ-5D Over Time
This endpoint is defined as differences in scores related to the EQ-5D questionnaire and the EQ-VAS measured at current and pre-discharge visits.
Measured: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, 5 years
Change in EQ-5D VAS Over Time
This endpoint is defined as differences in scores related to the EQ-5D VAS questionnaire and the EQ-VAS measured at current and pre-discharge visits.
Measured: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, 5 years
Change in KOOS, JR. Over Time
This endpoint is defined as difference in the KOOS, Jr interval score measured at current and pre-discharge visits.
Measured: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, 5 years
Radiographic Analysis
This endpoint is defined as incidence rate of new radiographic failures at each follow-up visit.
Measured: 24 months, 5 years
Operative characteristics
Descriptive statistics in operative characteristics will be reported as secondary endpoints to evaluate operative success
Measured: Operative
Subject Satisfaction Survey
Subject satisfaction with their knee surgery.
Measured: 6 weeks, 3 months, 6 months, 12 months, 2 Years, 3 Years, 4 Years and 5 Years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start30 Mar 2017
- Primary completion30 Mar 2024 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- United Orthopedic Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03060057
- Sponsor's protocol ID
- 03-2017
- Acronym
- U-Propel
- Status last verified
- Jun 2023
- First submitted
- 10 Feb 2017
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Post Approval Clinical Follow-Up Study of the Commercially Available U2 Knee™ System - "U-Propel Study"
- ClinicalTrials.gov ID
- NCT03060057
- Acronym / sponsor ID
- U-Propel / 03-2017
- Conditions
- Osteo Arthritis Knee
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- United Orthopedic CorporationIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2017 (actual)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 23 Feb 2017 (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 both short and long term clinical performance and safety of the commercially available U2 Knee™ System.
Detailed description
This is a prospective, single arm, multi-center, post-approval study designed to evaluate the short and long term clinical performance and safety in subjects receiving primary total knee arthroplasty (TKA) with the U2 Knee™ System. The study will enroll up to 200 subjects with scheduled pre-discharge, 6-week, 3- and 6-month and up to 5-year annual follow-up visits. Study outcomes will be analyzed and published when 1.) all enrolled and implanted subjects complete their 6-week follow up, 2.) all implanted subjects complete their 2-year follow up, 3.) at the conclusion of the study.
The study will follow GCP guidelines and will be registered on clinicaltrials.gov.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The U2 Knee™ System is intended for use in subjects who require primary total knee arthroplasty for reduction or relief of pain and/or improved knee function.
Key inclusion criteria (5 listed)
- Subject is between 18 and 75 years of age
- Subject is indicated for a unilateral total knee arthroplasty (TKA) based on the approved labeling of the device
- Subject has no history of previous prosthetic replacement device or orthopedic surgeries on the operative knee
- Subject is willing and able to provide informed consent to participate in the study;
- Subject is willing and able to understand the purpose of the study, his/her role, and is available to return to the clinic/hospital for all required follow-up visits;
Key exclusion criteria (1 listed)
- Subjects will be excluded if, in the opinion of the Investigator, the subject does not qualify based on approved labeling requirements or Subject Inclusion criteria.
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 |
|---|---|---|
| U2 Knee™ SystemThe United U2 Knee™ System consists of several components and for this clinical evaluation it includes the (1) Femoral Component, (2) Tibial Insert, 3) Tibial Baseplate, and the 4) Patella. | Device | – |
Primary outcome
Implant Survivorship
Time frame: 2 Years
Device Survivorship defined as no revision of removal of any parts of the system
7 secondary outcomes
Change in Knee Society Score (KSS) Over Time
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, 5 years
Change in EQ-5D Over Time
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, 5 years
Change in EQ-5D VAS Over Time
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, 5 years
Change in KOOS, JR. Over Time
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, 5 years
Radiographic Analysis
Time frame: 24 months, 5 years
Operative characteristics
Time frame: Operative
Subject Satisfaction Survey
Time frame: 6 weeks, 3 months, 6 months, 12 months, 2 Years, 3 Years, 4 Years and 5 Years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteo Arthritis Knee, run by United Orthopedic Corporation at 4 sites 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 1 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 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
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?
Implant Survivorship (time frame: 2 Years). 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 5 Jun 2023.