OsteoarthritisNCT06996158
Prospective Evaluation Assessing U2 MB™ Total Knee System
An observational study of Osteoarthritis and Musculoskeletal Abnormalities, run by MSK Doctors & Associates Ltd.
Trial summary
The goal of this study is to evaluate the safety and effectiveness of the United Orthopaedics Mobile Bearing Total Knee System (U2 MB™ Knee) in patients undergoing total knee replacement surgery due to end-stage knee osteoarthritis. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Osteoarthritis, Musculoskeletal Abnormalities
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 26 May 2025to 30 Nov 2038
- How long will I take part?
- 13 Years
- Phase
- Observational
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Clinic
Who may be able to join
- All patients suitable for a cemented Total Knee Replacement, MBC design
- All elective pathology (including Osteoarthritis, Rheumatoid arthritis, Post-traumatic arthritis not requiring stemmed components, Avascular necrosis)
- Willing to voluntarily sign the informed consent form
- Willing and able to comply with the protocol, able to read and complete the required forms, and willing and able to adhere to the requirements of the protocol through the 10-year postoperative follow-up visit.
Who cannot join
- Skeletally immature (less than 21 years of age) at time of implantation
- Active native knee joint infection
- Post-traumatic arthritis requiring stemmed components
- Malignancy around the knee
- All patients who are personally unable to take part in fully informed consent (dementia, reduced AMTS etc)
- Patients who will not be available to return for the predetermined appointments in order to complete the 10 years follow-up
- Has inadequate neuromuscular status (e.g., prior paralysis, fusion, and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable
- Currently enrolled in another clinical investigation which could affect the endpoints of this protocol
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective Evaluation Assessing Performance, Survivorship and Patient Reported Outcome Measures of Mobile Bearing Total Knee System (U2 MB™ Knee).
The goal of this study is to evaluate the safety and effectiveness of the United Orthopaedics Mobile Bearing Total Knee System (U2 MB™ Knee) in patients undergoing total knee replacement surgery due to end-stage knee osteoarthritis. The main questions it aims to answer are:
- What is the component survivorship of the U2 MB™ Knee system at 1, 3, 5, and 10 years?
Read more
Participants will:
- Return for follow-up assessments at Year 1, Year 3, Year 5, and Year 10 after surgery
- Undergo clinical evaluations including functional outcome scoring, radiographic imaging.
This study will take place across three investigational sites and will involve 150 knee replacements using U2 MB™ components. The study's objectives include assessing early to long-term outcomes in terms of implant survivorship, clinical function, patient satisfaction, radiological findings, and overall safety of the device over a 10-year period.
Read the detailed description
Non-interventional prospective follow-up study.
- Conditions
- Osteoarthritis, Musculoskeletal Abnormalities
- Medical subject headings
- Osteoarthritis, Musculoskeletal Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Knee implant group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of the survivorship of the U2 MB™ Knee system and its components, defined as no removal or revision of any components during a 10-year interval after implantation.
Measured: 10 years
Secondary outcomes (1)
Two standardized scores will grade the functional score of the knee joint over time: Knee Society Score (KSS) and Oxford Knee Score (OKS)
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start26 May 2025 (estimated)
- Primary completion27 May 2038 (estimated)
- Study completion30 Nov 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 13 Years
Sponsor and investigators
- Lead sponsor
- MSK Doctors & Associates Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United Orthopedics Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06996158
- Sponsor's protocol ID
- 25/WM/0048
- Status last verified
- May 2025
- First submitted
- 21 May 2025
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.
PubMed 17403800
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation Assessing Performance, Survivorship and Patient Reported Outcome Measures of Mobile Bearing Total Knee System (U2 MB™ Knee).
- ClinicalTrials.gov ID
- NCT06996158
- Acronym / sponsor ID
- 25/WM/0048
- Conditions
- Osteoarthritis, Musculoskeletal Abnormalities
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- MSK Doctors & Associates LtdIndustry (pharma, biotech, devices)
- Collaborators
- United Orthopedics Inc.
- Study start
- 26 May 2025 (estimated)
- Primary completion
- 27 May 2038 (estimated)
- Study completion
- 30 Nov 2038 (estimated)
- First posted
- 30 May 2025 (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 goal of this study is to evaluate the safety and effectiveness of the United Orthopaedics Mobile Bearing Total Knee System (U2 MB™ Knee) in patients undergoing total knee replacement surgery due to end-stage knee osteoarthritis. The main questions it aims to answer are:
- What is the component survivorship of the U2 MB™ Knee system at 1, 3, 5, and 10 years?
Participants will:
- Return for follow-up assessments at Year 1, Year 3, Year 5, and Year 10 after surgery
- Undergo clinical evaluations including functional outcome scoring, radiographic imaging.
This study will take place across three investigational sites and will involve 150 knee replacements using U2 MB™ components. The study's objectives include assessing early to long-term outcomes in terms of implant survivorship, clinical function, patient satisfaction, radiological findings, and overall safety of the device over a 10-year period.
Detailed description
Non-interventional prospective follow-up study.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 13 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Knee implant group | – | – |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinic
Key inclusion criteria (4 listed)
- All patients suitable for a cemented Total Knee Replacement, MBC design
- All elective pathology (including Osteoarthritis, Rheumatoid arthritis, Post-traumatic arthritis not requiring stemmed components, Avascular necrosis)
- Willing to voluntarily sign the informed consent form
- Willing and able to comply with the protocol, able to read and complete the required forms, and willing and able to adhere to the requirements of the protocol through the 10-year postoperative follow-up visit.
Key exclusion criteria (8 listed)
- Skeletally immature (less than 21 years of age) at time of implantation
- Active native knee joint infection
- Post-traumatic arthritis requiring stemmed components
- Malignancy around the knee
- All patients who are personally unable to take part in fully informed consent (dementia, reduced AMTS etc)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Study of the survivorship of the U2 MB™ Knee system and its components, defined as no removal or revision of any components during a 10-year interval after implantation.
Time frame: 10 years
1 secondary outcome
Two standardized scores will grade the functional score of the knee joint over time: Knee Society Score (KSS) and Oxford Knee Score (OKS)
Time frame: 10 years
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 30 May 2025.
- Background: PubMed 17403800Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.
- Individual participant dataSharing planned: No
Related trials for 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis and Musculoskeletal Abnormalities, run by MSK Doctors & Associates Ltd.
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 4 inclusion and 8 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: opening soon, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Paul Principal Investigator (0330 001 0048, paul.lee@mskdoctors.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study of the survivorship of the U2 MB™ Knee system and its components, defined as no removal or revision of any components during a 10-year interval after implantation. (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06996158, which also lists 1 linked publication.
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 30 May 2025.