Prospective Evaluation Assessing U2 MB™ Total Knee System | NCT06996158

Studies
Prospective Evaluation Assessing U2 MB™ Total Knee System

NCT06996158

Sponsor

MSK Doctors & Associates Ltd

Status

Not yet recruiting

Last Update Posted

May 30, 2025Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Osteoarthritis
Musculoskeletal Abnormalities

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 26, 2025Estimated

Primary Completion Date

May 27, 2038Estimated

Completion Date

Nov 30, 2038Estimated

First Submitted Date

May 21, 2025

First Submission Date that Met QC Criteria

May 21, 2025

First Posted Date

May 30, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 21, 2025

Last Update Posted Date

May 30, 2025Actual

Name	Class
United Orthopedics Inc.	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

13 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Label	Type	Description	Intervention Names
Knee implant group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.		10 years

Secondary Outcomes

Measure	Description	Time Frame
Two standardized scores will grade the functional score of the knee joint over time: Knee Society Score (KSS) and Oxford Knee Score (OKS)		10 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Paul Principal Investigator	Contact	0330 001 0048		paul.lee@mskdoctors.com
Tanvi Research Associate	Contact	0330 001 0048		tanvi@mskdoctors.com

Overall Officials

Not provided

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17403800	Background	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.

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

ID	Term
D010003	Osteoarthritis
D009139	Musculoskeletal Abnormalities