Safety and Performance Study of the Legion Porous System in Total Knee Arthroplasty

Total Knee Arthroplasty Clinical Trial

Official title:

Multi-center Study of the Safety and Performance of Primary Total Knee Arthroplasty With LEGION™ Porous HA Tibial Baseplates (With and Without Holes) and/or the LEGION™ Porous HA CR Femoral Component in US Centers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03720782
• Other study ID #: LEGHA.PMCF.2018.07
• Status: Active, not recruiting
• Start date: May 22, 2019
• Est. completion date: December 31, 2032

Study information

• Verified date: April 2024
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this research is to collect data on patients that had the Legion Porous HA Tibial Baseplates and/or the Legion Porous HA Femoral component implanted in the past. Smith & Nephew will evaluate the safety and performance of these implants for 10 years post-surgery.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 118
• Est. completion date: December 31, 2032
• Est. primary completion date: January 23, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject received primary TKA with the LEGION Porous HA Tibial Baseplates (either with holes or without holes) and/or the LEGION Porous HA CR Femoral Component, due to degenerative joint disease (primary diagnosis of osteoarthritis, post-traumatic arthritis, or degenerative arthritis).

2. Subject received primary TKA between 24 and 60 months prior to the time of consent.

Inclusion criteria for prospective follow-up (subjects must meet criteria 1 & 2 from above and criteria 3,4 and 5 below):

3. Subject agrees to consent and to follow the prospective study visit schedule (as defined in the study protocol and informed consent form) by signing the IRB/IEC approved informed consent form.

4. Subject must be available through ten (10) years postoperative follow-up.

5. Subject is able to read, understand, and communicate responses to Patient Reported Outcome assessments in English.

Exclusion Criteria:

Exclusion criteria for retrospective chart review - Any one (1) of the following criteria will disqualify a potential subject from participation in the retrospective chart review:

1. Subject received TKA on the contralateral knee as a revision for a previously failed total or unicondylar knee arthroplasty

2. Subject has ipsilateral hip arthritis resulting in flexion contracture.

3. At the time of enrollment, subject has one or more of the following arthroplasties that are not fully healed and well-functioning, as determined by the investigator: Ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty; Contralateral primary total knee or unicondylar knee arthroplasty.

4. Subject has a condition that may interfere with the TKA survival or outcome (e.g. Paget's or Charcot's disease, vascular insufficiency, lupus, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease).

5. Subject has a known allergy to one or more of its components of the study device.

6. Subject is entered in another drug, biologic, or device study or has been treated with an investigational product in the past 30 days.

Exclusion criteria for prospective follow-up - Any one (1) of the criteria from 1-6 above will disqualify a potential subject from participation in the prospective follow-up) as will any one (1) of the below criteria 7, 8 and 9:

7. Subject, in the opinion of the Principal Investigator (PI), has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse.

8. Subject is known to be at risk for loss to follow-up, or failure to return for scheduled visits.

9. Subject is found to have had a revision of the study device(s).

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

Device:
• LEGION Porous HA Tibial Baseplate and/or the LEGION Porous HA CR Femoral Component
LEGION Porous HA Tibial Baseplate (with and without holes) and/or the LEGION Porous HA CR Femoral Component

Locations

Country	Name	City	State
United States	Twin Cities Orthopedics	Coon Rapids	Minnesota
United States	Saint Louis University Hospital, Dept. of Orthopaedic Surgery	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant survivorship 10 years post-surgery		10 years
Secondary	Quality of life - KOOS JR	Patient Reported Outcomes using Knee Injury and Osteoarthritic Outcome Scores (KOOS JR) questionnaire	10 years
Secondary	Quality of Life - Forgotten Joint Score (FJS)	Patient Reported Outcomes using Forgotten Joint Score (FJS) questionnaire	10 years
Secondary	Quality of life - EQ-5D-5L	Patient Reported Outcomes using EuroQol Five Dimensions Questionnaire (EQ-5D - 3L) questionnaire	10 years
Secondary	Implant survivorship	Implant Survivorship at 5 years defined as the cumulative proportion of knee-implanted components without a revision	5 years
Secondary	Radiographic findings	X-ray of implanted knee- 3 views (AP, Lateral and Skyline/Merchant) to observe any radiographic findings that may include; Heterotopic ossification, oteolysis, femoral notching, evidence of poly wear, radiolucencies.	10 years