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

NCT ID: NCT03720782

Last Updated: 2024-04-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 118 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-05-22
• Study Completion Date: 2032-12-31

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.

Conditions

Total Knee Arthroplasty

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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.

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

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.

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Smith & Nephew, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karlie Morgan

Role: STUDY_CHAIR

Smith & Nephew, Inc.

Locations

Twin Cities Orthopedics

Coon Rapids, Minnesota, United States

Saint Louis University Hospital, Dept. of Orthopaedic Surgery

St Louis, Missouri, United States

Countries

United States

Other Identifiers

LEGHA.PMCF.2018.07

Identifier Type: -

Identifier Source: org_study_id