LEGION™ Primary Safety and Efficacy

A Prospective, Multi-Center, Non-Randomized, Safety and Efficacy Clinical Study of the LEGION™ Primary Knee System for Primary Total Knee Replacement in Subject With Degenerative Knee Disease

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04040985

Enrollment

128

Registered

2019-08-01

Start date

2009-09-09

Completion date

2020-12-17

Last updated

2024-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteo Arthritis Knee, Total Knee Replacement

Keywords

LEGION™ Primary, TKA, Osteoarthritis of Knee

Brief summary

This study will look at the health results of using the LEGION™ Primary Knee System over a period of ten (10) years. This type of surgery uses an artificial knee made of plastic and metal. This study will enter subjects who suffer from a variety of conditions that have caused at least one of their knees to become nonfunctional. You are being asked to participate in the study because you have significant problems with your knee(s) and your study surgeon has determined that your knee(s) must be surgically replaced to improve your condition. If you decided to participate in this study, you will be one of approximately one hundred thirty-eight (138) subjects in the study.

Detailed description

This is a prospective, consecutive series, multi-center clinical study of the LEGION™ Total Knee System. The study design was selected to assess the safety and effectiveness profile of the LEGION™ Total Knee System in subjects with degenerative knee disease requiring primary total knee replacement. Subjects meeting the entrance criteria specified in this protocol will be approached to participate in the study and enrolled sequentially. Any consenting subjects meeting the inclusion criteria are not to be excluded unless they do not consent to participate. A nonrandomized, consecutive series of up to 138 subjects will be enrolled at a maximum of 8 research sites, with an expectation of 18 subjects (up to a maximum of 28 subjects) to be enrolled at each site. When 138 subjects are enrolled from all sites, enrollment will be stopped, regardless of the number contributed from each site. Sites will be selected for participation in the study at the discretion of Smith & Nephew. Follow-up clinical assessments will be at Operative/Discharge, 3 months, 1 year, 2 years, 3 years, 5 years, 7 years and 10 years. Each subject will receive a standard radiographic evaluation at discharge that will be used for baseline analysis. Additional radiographic analysis will be performed at Operative/Discharge, 3 months, 1 year, 2 years, 3 years, 5 years, 7 years and 10 years.

Interventions

PROCEDURETotal Knee Arthroplasty using LEGION™ Total Knee System

Primary Total Knee Arthroscopy using LEGION™ Total Knee System

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Subjects must meet all of the inclusion criteria: * Subject is a candidate for the LEGION™ Primary Knee System according to the instructions for use * Subject is of legal age and skeletally mature * Subject is willing to sign and date an ethics-approved consent form and participate in the study * Subject is willing to be available for ten-year follow-up postoperatively.

Exclusion criteria

Subjects must not meet any of the

Design outcomes

Primary

Measure	Time frame	Description
Implant Survivorship Percentage	Postoperatively through 120 months	Kaplan-Meier (KM) implant survivorship where survivorship defined as percentage of knees where no revision was required for any reason through 120 months

Secondary

Measure	Time frame	Description
Knee Society Score (KSS) - Function	Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months	The Knee Society Score (KSS) function outcome comprised information on functional knee indicators related to walking & standing, standard activities, advanced activities, and discretionary activities. The Function Score ranged from 0 to 100 with a higher score indicating a better outcome.
Knee Osteoarthritis Outcome Score (KOOS) - Pain	Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months	The Knee Osteoarthritis Outcome Score (KOOS) Pain subscale used a Likert scale from 0 (No Problems) to 4 (Extreme Problems). Scores are transformed to a 0-100 scale, with 0 indicated a worse outcome and 100 representing a better outcome.
Knee Osteoarthritis Outcome Score (KOOS) - Symptom	Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months	The Knee Osteoarthritis Outcome Score (KOOS) Symptom subscale used a Likert scale from 0 (No Problems) to 4 (Extreme Problems). Scores are transformed to a 0-100 scale, with 0 indicated a worse outcome and 100 representing a better outcome.
Knee Osteoarthritis Outcome Score (KOOS) - Function in Daily Living (ADL)	Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months	The Knee Osteoarthritis Outcome Score (KOOS) Function in Daily Living (ADL) subscale used a Likert scale from 0 (No Problems) to 4 (Extreme Problems). Scores are transformed to a 0-100 scale, with 0 indicated a worse outcome and 100 representing a better outcome.
Knee Society Score (KSS) - Performance	Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months	The Knee Society Score (KSS) performance outcome comprised information on objective knee indicators related to everyday activities. The Performance Score ranged from 0 to 100 with a higher score indicating a better outcome.
Knee Osteoarthritis Outcome Score (KOOS) - Quality of Life (QoL)	Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months	The Knee Osteoarthritis Outcome Score (KOOS) Quality of Life (QoL) subscale used a Likert scale from 0 (No Problems) to 4 (Extreme Problems). Scores are transformed to a 0-100 scale, with 0 indicated a worse outcome and 100 representing a better outcome.
Radiographic Evaluation - Radiolucent Lines	Discharge, 3 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years	Performed weight bearing AP and lateral standard x-rays to identify knees with presence or absence of radiolucent lines categorized as: * Findings in Femoral Zone * Findings in Tibial Mediolateral (ML) Zone * Findings in Tibial Anteroposterior (AP) Zone * Findings in Patella Zone * No Radiolucent Lines Found
Radiographic Evaluation - Observed Periosteal Hypertrophy, Implant Loosening, Osteolysis or Subsidence	Discharge, 3 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years	Performed weight bearing AP and lateral standard x-rays to identify knees that observed periosteal hypertrophy, implant loosening, osteolysis or subsidence (Yes/No).
Radiographic Evaluation - Observed Patellar Problem	Discharge, 3 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years	Performed weight bearing AP and lateral standard x-rays to identify knees that observed patellar problems (Yes/No).
Knee Osteoarthritis Outcome Score (KOOS) - Sports and Recreational Activities	Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months	The Knee Osteoarthritis Outcome Score (KOOS) Sports and Recreational Activities subscale used a Likert scale from 0 (No Problems) to 4 (Extreme Problems). Scores are transformed to a 0-100 scale, with 0 indicated a worse outcome and 100 representing a better outcome.

Countries

United States

Participant flow

Participants by arm

Arm	Count
LEGION™ Primary LEGION™ Primary Total Knee Arthroplasty (TKA) Total Knee Arthroplasty using LEGION™ Total Knee System: Primary Total Knee Arthroscopy using LEGION™ Total Knee System	128
LEGION™ Primary LEGION™ Primary Total Knee Arthroplasty (TKA) Total Knee Arthroplasty using LEGION™ Total Knee System: Primary Total Knee Arthroscopy using LEGION™ Total Knee System	138
Total	266

Baseline characteristics

Characteristic	LEGION™ Primary
Age, Continuous	66.2 years STANDARD_DEVIATION 8.45
Age, Customized Age Group ≤ 60 years	34 knees
Age, Customized Age Group > 60 years	104 knees
Body Mass Index (BMI)	31.1 kg/m^2 STANDARD_DEVIATION 6.06
Knee side implanted with device Left	69 knees
Knee side implanted with device Right	69 knees
Region of Enrollment United States	128 Participants
Sex: Female, Male Female	89 knees
Sex: Female, Male Male	49 knees

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	4 / 128
other Total, other adverse events	116 / 128
serious Total, serious adverse events	75 / 128

Outcome results

Primary

Implant Survivorship Percentage

Kaplan-Meier (KM) implant survivorship where survivorship defined as percentage of knees where no revision was required for any reason through 120 months

Time frame: Postoperatively through 120 months

Arm	Measure	Value (NUMBER)
LEGION™ Primary	Implant Survivorship Percentage	96.9 percentage of knees

Secondary

Knee Osteoarthritis Outcome Score (KOOS) - Function in Daily Living (ADL)

The Knee Osteoarthritis Outcome Score (KOOS) Function in Daily Living (ADL) subscale used a Likert scale from 0 (No Problems) to 4 (Extreme Problems). Scores are transformed to a 0-100 scale, with 0 indicated a worse outcome and 100 representing a better outcome.