Safety and Performance Using Legion™ CR Oxinium and CoCr Femoral Implants Combined With Legion™/Genesis™ II XLPE High Flex Tibial Inserts

Total Knee Arthroplasty Clinical Trial

— Legion Oxinium  

Official title:

Safety and Performance of Primary Total Knee Arthroplasty Using Legion™ CR Oxinium and CoCr Femoral Implants Combined With Legion™/Genesis™ II XLPE High Flex Tibial Inserts

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03687593
• Other study ID #: 17-4042-10
• Status: Active, not recruiting
• Start date: August 26, 2018
• Est. completion date: April 1, 2028

Study information

• Verified date: December 2023
• 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 CR Oxinium and CoCr Femoral Implant and the Legion/Genesis II XLPE High Flex Tibial Inserts implanted in the past. Smith & Nephew will evaluate the safety and performance of these implants.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 126
• Est. completion date: April 1, 2028
• Est. primary completion date: October 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject received primary TKA with the Legion™ CR Femoral Implant (either Oxinium or CoCr) with Legion™/Genesis™ II XLPE Hi-flex Tibial Insert, due to degenerative joint disease (primary diagnosis of osteoarthritis, post-traumatic arthritis, degenerative arthritis, or rheumatoid arthritis).

2. Subject received primary TKA between 24 and 66 months prior to the time of consent.

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

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

Exclusion Criteria:

1. Subject had Body Mass Index (BMI) > 40 at time of surgery.

2. Subject received the Legion™ CR Femoral Implant with Legion™/Genesis™ II XLPE Hi-flex Tibial Insert as a revision surgery.

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

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

5. 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.

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

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

Device:
• Legion™ CR Oxinium and CoCr Femoral Implants combined with Legion™/Genesis™ II XLPE High Flex Tibial Inserts
Single arm study, all subjects received the Legion™ CR Femoral Oxinium and CoCr Implant with Legion™/Genesis™ II XLPE Hi-flex Tibial Insert

Locations

Country	Name	City	State
United States	Allina Health Systems	Edina	Minnesota
United States	Hawkins Foundation	Greenville	South Carolina
United States	Appalachian Orthopedic Associates	Johnson City	Tennessee
United States	ROC Foundation	Reno	Nevada

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 survival 10 years postoperatively		10 years post-op