Post Market Clinical Follow-Up Study for EVOLUTION® NitrX™ Keeled Tibia and EVOLUTION® NitrX™ CS/CR Femur With Cruciate Sacrificing Insert

NCT04816773 | Enrolling By Invitation FDA Device

• 1 other identifier: 20K001
• Study Type: observational
• Target: 150
• Locations: 2 countries
• Sites: 2

Brief Summary

MicroPort Orthopedics Inc. (MPO) plans to market the EVOLUTION® NitrX™ Non-Porous Keeled Tibia and EVOLUTION® NitrX™ CS/CR Non-Porous Femur with the EVOLUTION® Cruciate Sacrificing (CS) Tibial Insert globally, including in the European Union (EU). MPO is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and effectiveness of the EVOLUTION® NitrX™ Non-Porous Keeled Tibia and EVOLUTION® NitrX™ CS/CR Non-Porous Femur. These components are used along with the EVOLUTION® Cruciate Sacrificing (CS) Tibial Insert components that is marketed in the European Union (EU). This type of data collection is required by regulatory authorities for all TKA devices that do not have medium to long-term clinical evidence available.

Conditions

Joint Diseases; Osteoarthritis; Arthritis Knee; Avascular Necrosis

Outcome Measures

Primary Outcomes (3)

• Component Survivorship of the EVOLUTION® NitrX™ Non-Porous Keeled Tibia

  The primary endpoint is to evaluate component survivorship of the EVOLUTION® NitrX™ Non-Porous Keeled Tibia out to 10 years follow-up. Percentage of knees survived with no revisions or replacement at 10-year

  10 years post-operative

• Component Survivorship of the EVOLUTION® NitrX™ CS/CR Non-Porous Femur

  The primary endpoint is to evaluate component survivorship of the EVOLUTION® NitrX™ CS/CR Non-Porous Femur out to 10 years follow-up. Percentage of knees survived with no revisions or replacement at 10-year.

  10 years post-operative

• Component Survivorship of the EVOLUTION® NitrX™ MP CS tibial inserts

  The primary endpoint is to evaluate component survivorship of the EVOLUTION® NitrX™ MP CS tibial inserts out to 10 years follow-up. Percentage of knees survived with no revisions or replacement at 10-year.

  10 years post-operative

Secondary Outcomes (7)

• Functional Scores

  10 years post-operative

• Functional Scores

  10 years post-operative

• Functional Scores

  10 years post-operative

• Subject Satisfaction

  10 years post-operative

• Radiolucencies

  10 years post-operative

Study Arms (1)

Newly or previously implanted patients

Multicenter, non-interventional prospective follow-up of newly or previously implanted subjects. Previously implanted subjects must be enrolled within 14 months of the study index surgery. Single study group with either newly or previously implanted patients with all EVOLUTION® NitrX™ components: Non-Porous Keeled Tibia, CS/CR Non-Porous Femur component, and EVOLUTION® MP CS tibial insert

Device: EVOLUTION® NitrX™

Interventions

EVOLUTION® NitrX™ DEVICE

EVOLUTION® NitrX™ Keeled Tibia and EVOLUTION® NitrX™ CS/CR Femur With Cruciate Sacrificing Insert

Newly or previously implanted patients

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Single study group with either newly or previously implanted patients with all EVOLUTION® NitrX™ components: Non-Porous Keeled Tibia, CS/CR Non-Porous Femur component, and EVOLUTION® MP CS tibial insert

You may qualify if:

• Has previously undergone or currently has determined to undergo a primary TKA with the specified combination of components: EVOLUTION® NitrX™ CS/CR Non-Porous Femur, EVOLUTION® NitrX™ Non-Porous Keeled Tibia and EVOLUTION® CS Tibial Insert
• Has previously undergone or currently has determined to undergo a primary TKA for any of the following:
• non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
• inflammatory degenerative joint disease including rheumatoid arthritis;
• correction of functional deformity;
• 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.
• Previously implanted subjects must be enrolled within 14 months of their primary TKA implantation.
• Prospective enrollment of a previously unimplanted contralateral knee is permitted in this study provided:
• the specified combination of components (EVOLUTION® NitrX™ CS/CR Non-Porous Femur, EVOLUTION® NitrX™ Non-Porous Keeled Tibia and EVOLUTION® CS Tibial Insert) are used,

You may not qualify if:

• enrollment does not exceed the subject count specified in the Clinical Trial Agreement, and
• the subject agrees to a second Informed Consent document and data collection specific to the second TKA.
• Bilateral subjects can have both TKAs enrolled in the study provided:
• the specified combination of components (EVOLUTION® NitrX™ CS/CR Non-Porous Femur, EVOLUTION® NitrX™ Non-Porous Keeled Tibia and EVOLUTION® CS Tibial Insert) were implanted in both,
• enrollment does not exceed the subject count specified in the Clinical Trial Agreement, and
• the subject agrees to a second Informed Consent document and data collection specific to the second TKA.
• Bilateral implantation can occur at different time periods for the same subject.
• Skeletally immature (less than 21 years of age) at time of implantation
• Has or had an overt infection at the time of implantation
• Has or had a distant foci of infections (which may cause hematogenous spread to the implant site) at the time of implantation
• Has or had a rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram at the time of implantation
• Has or had 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
• Has documented substance abuse issues
• Has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study

Sponsors & Collaborators

• MicroPort Orthopedics Inc.: lead

Study Sites (2)

Sah Orthopaedic Associates

Fremont, California, 94538, United States

Location

MSK Doctors, The Keep Clinic

Grantham, Lincolnshire, NG31 9AS, United Kingdom

Location

MeSH Terms

Conditions

Joint Diseases; Osteoarthritis; Osteonecrosis

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Arthritis; Rheumatic Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 25, 2021
• Study Start: January 27, 2022
• Primary Completion (Estimated): August 1, 2034
• Study Completion (Estimated): January 1, 2035
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); GB (1)