Post Market Clinical Follow-Up Study- EVOLUTION® Revision CCK

Post Market Clinical Follow-Up Study for EVOLUTION® Revision Tibial System and EVOLUTION® Revision Constrained Condylar Knee (CCK) Femur With the EVOLUTION® CCK Tibial Insert

Sponsor is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its EVOLUTION® Revision CCK Tibia and EVOLUTION® Revision CCK Femur with EVOLUTION® CCK Tibial inserts. These type of studies are required by regulatory authorities for all devices that have been approved in Europe (EU) to evaluate the medium and long term clinical evidence. This study has been designed in accordance with MEDDEV2.12/2 rev 2 (European Medical Device Vigilance System) and ISO (International Organization for Standardization) 14155:2011 guidelines.

Study Overview

• Status: Enrolling by invitation
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Device: Revision Knee implants

Detailed Description

The objectives of this study are:

1. To estimate the individual component survivorship of EVOLUTION® Revision Tibia, EVOLUTION® Revision CCK Femur, and EVOLUTION® CCK Tibial Insert.
2. To find out the cumulative incidence of component revision of each component in this combination.
3. To find out the functional outcome scores at early, midterm, and long-term follow-up.

• Study Type: Observational
• Enrollment (Estimated): 45

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Englewood, Colorado, United States, 80113
      • HCA Research Institute, OrthoONE at Swedish Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Primary TKA or Revision

Single study group with either newly or previously implanted patients with EVOLUTION® Revision Tibia and EVOLUTION® Revision CCK Femur with the EVOLUTION® CCK Insert.

Description

Inclusion Criteria:

1. Has previously undergone or currently has been determined to undergo a revision knee arthroplasty that requires the study (EVOLUTION® Revision Tibial System and EVOLUTION® Revision CCK Femur with the EVOLUTION® CCK Tibial Insert)
2. Decision to perform the study index surgery with the required study components (EVOLUTION® Revision Tibial System and EVOLUTION® Revision CCK Femur with the EVOLUTION® CCK Tibial Insert) is pre-determined regardless of the research.
3. Previously implanted subjects must be enrolled within 3 years (+6 months) of their study index surgery
4. Willing and able to complete required study visits and assessments through the 10 year post-operative follow-up visit.

Bilateral subjects can have both TKAs enrolled in the study provided:

1. the specified combination of components (EVOLUTION® Revision Tibial System and EVOLUTION® Revision CCK Femur with the EVOLUTION® CCK Tibial Insert) were implanted in both
2. all other aspects of the Inclusion/Exclusion Criteria are satisfied
3. enrollment does not exceed the subject count specified
4. the subject agrees to a second Informed Consent document and data collection specific to the second TKA.

Exclusion Criteria:

1. Skeletally immature (less than 21 years of age) at time of implantation.
2. Has an overt infection at the time of implantation.
3. 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.
4. Currently enrolled in another clinical investigation which would affect the endpoints of this protocol.
5. Has documented substance abuse issues.
6. Has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study.
7. Currently incarcerated or has impending incarceration.
8. Has a medical condition, as judged by the Investigator, that would interfere with the subject's ability to comply with the requirements of the protocol.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Individual component survivorship	Individual component survivorship for tibial base, femoral, and tibial insert at specified intervals out to 10 years follow-up.	10 years post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Reported Outcomes- Questionnaires	functional scores for subjects, as assessed by Knee Injury and Osteoarthritis Outcome Score (KOOS), out to 10 years follow-up; functional scores for subjects, as assessed by EuroQol-5D-5L (EQ-5D-5L) Scores, out to 10 years follow-up; subject satisfaction measures with their Total Knee Arthroplasty (TKA) procedure using the Forgotten Joint Score; subject satisfaction measures with their TKA procedure using the Satisfaction Survey	10 years post-operative
Incidence of component revision	the cumulative incidence of component revision at specified intervals will be determined out to 10 years follow-up	10 years post-operative
Radiolucencies	the presence, zone, and the size of radiolucencies surrounding implanted components will be determined	10 years post-operative
Adverse Events and Adverse Device Effects	characterization of adverse events and adverse device effects	10 years post-operative

Collaborators and Investigators

• Sponsor: MicroPort Orthopedics Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2020
• Primary Completion (Estimated): May 1, 2033
• Study Completion (Estimated): November 1, 2033

Study Registration Dates

• First Submitted: October 17, 2019
• First Submitted That Met QC Criteria: October 28, 2019
• First Posted (Actual): October 30, 2019

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: rheumatoid arthritis; Osteoarthritis; avascular necrosis; correction of functional deformity; revision procedures; traumatic arthritis
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 18K001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes