Post Market Follow-Up Study of the EVOLUTION® Total Knee Arthroplasty System With Cruciate Sacrificing Inserts

NCT02351414 | Active Not Recruiting

• 1 other identifier: 13-LJK-001
• Study Type: observational
• Target: 150
• Locations: 5 countries
• Sites: 5

Brief Summary

MPO is conducting this PMCF study to evaluate the safety and efficacy of its EVOLUTION® Total Knee Arthroplasty (TKA) components marketed in the EU. These types of studies are required by regulatory authorities for all devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. This study has been designed in accordance with MEDDEV 2.12/2 rev 2.

Conditions

Joint Disease

Keywords

Osteoarthritis; Ankylosis; Revision procedures; Correction of functional deformity; Rheumatoid arthritis; Arthritis

Outcome Measures

Primary Outcomes (1)

• Component Survivorship

  The primary endpoints are analysis of survivorship for all components at each follow-up interval out to 10 years

  10 years post-operative

Secondary Outcomes (5)

• Patient functional outcomes scores (assessed by KOOS Scores and EQ-5D-3L Scores)

  2-<5 years, 5-7 years, and 10 years

• Cumulative Revision Rate

  2-<5 years, 5-7 years, and 10 years

• Subject Satisfaction (assessed by Patient Satisfaction Questionnaires)

  2-<5 years, 5-7 years, and 10 years

• Number of Radiolucencies

  2-<5 years, 5-7 years, and 10 years

• Size of Radiolucencies

  2-<5 years, 5-7 years, and 10 years

Study Arms (1)

Primary Total Knee Arthroplasty

Single study group previously implanted with the EVOLUTION® TKA System with cruciate sacrificing (CS) inserts

Device: Total Knee Arthroplasty (EVOLUTION®)

Interventions

Total Knee Arthroplasty (EVOLUTION®) DEVICE

Also known as: EVOLUTION® Total Knee Arthroplasty System with CS Inserts, EVOLUTION® CS

Primary Total Knee Arthroplasty

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

Patients who have been previously implanted with the EVOLUTION® TKA System with cruciate sacrificing (CS) inserts

You may qualify if:

• To be included in the study, subjects must meet all of the following criteria:
• Has previously undergone 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.
• Subject was implanted with the specified combination of components
• Subject is willing and able to complete required study visits and assessments
• Subject plans to be available through the 10 year postoperative follow-up visit
• Subject is willing to sign the approved Informed Consent document
• Subject must be at least 2 years post TKA prior to informed consent.

You may not qualify if:

• Subjects will be excluded if they meet any of the following criteria:
• Subject was skeletally immature (less than 21 years of age) at time of implantation
• Subject is currently enrolled in another clinical investigation
• Subject is unwilling or unable to sign the Informed Consent document
• Subject has documented substance abuse issues
• Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
• Subject has a body mass index (BMI) of greater than 40
• Subject is currently incarcerated or has impending incarceration

Sponsors & Collaborators

• MicroPort Orthopedics Inc.: lead

Study Sites (5)

Illinois Bone & Joint Institute

Morton Grove, Illinois, 60053, United States

Location

AZ Maria-Middelares

Ghent, Belgium

Location

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Klinik für Orthopädie, Unfall- und Wiederherstellungschirurgie, St. Marien Hospital Mülheim an der Ruhr

Mülheim, D-45468, Germany

Location

University Hospital Llandough

Penarth, South Glamorgan, CF64 2XX, United Kingdom

Location

MeSH Terms

Conditions

Joint Diseases; Osteoarthritis; Ankylosis; Arthritis, Rheumatoid; Arthritis

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Design

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

Study Record Dates

• First Submitted: January 22, 2015
• First Posted: January 30, 2015
• Study Start: June 15, 2015
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: October 13, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); DE (1); US (1); CA (1); GB (1)