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

Active, not recruiting

• Conditions: Total Knee Arthroplasty

• Registration Number: NCT03720782
• Lead Sponsor: Smith & Nephew, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-19
• Study First Submitted QC: 2018-10-24
• Study First Posted: 2018-10-25
• Study Start: 2019-05-22
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-02
• Primary Completion: 2031-01-23
• Study Completion: 2032-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 118

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Implant survivorship 10 years post-surgery	10 years

Secondary Outcome Measures

Name	Time	Method
Quality of Life - Forgotten Joint Score (FJS)	10 years	Patient Reported Outcomes using Forgotten Joint Score (FJS) questionnaire
Quality of life - KOOS JR	10 years	Patient Reported Outcomes using Knee Injury and Osteoarthritic Outcome Scores (KOOS JR) questionnaire
Quality of life - EQ-5D-5L	10 years	Patient Reported Outcomes using EuroQol Five Dimensions Questionnaire (EQ-5D - 3L) questionnaire
Radiographic findings	10 years	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.
Implant survivorship	5 years	Implant Survivorship at 5 years defined as the cumulative proportion of knee-implanted components without a revision

Trial Locations

Locations (2)

Saint Louis University Hospital, Dept. of Orthopaedic Surgery; 🇺🇸 Saint Louis, Missouri, United States

Twin Cities Orthopedics; 🇺🇸 Coon Rapids, Minnesota, United States