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Osteo Arthritis KneeNCT04040985

LEGION™ Primary Safety and Efficacy

A study testing Total Knee Arthroplasty using LEGION™ Total Knee System in people with Osteo Arthritis Knee and Total Knee Replacement, run by Smith & Nephew, Inc. at 5 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Osteo Arthritis Knee, Total Knee Replacement
What is being tested?
Total Knee Arthroplasty using LEGION™ Total Knee System
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
5 sitesUnited States
Study dates
9 Sep 2009to 17 Dec 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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 exclusion criteria:

  • Subject with immunosuppressive disorders
  • Subject has grossly insufficient femoral or tibial bone stock
  • Subject has an active localized or systemic infection
  • Subject is pregnant
  • Subject psychological or neurological conditions that would impair the subject's ability or willingness to restrict activities or follow medical advice during the course of this study
  • Subject is a prisoner.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Iowa Orthopaedic Center

    Des Moines, Iowa, 50314

  • Louisville Bone & Joint Specialist, PSC

    Louisville, Kentucky, 40207

  • University Hip and Knee Specialists

    Monroe, New Jersey, 08831

  • University Orthopaedic Associates, LLC

    Somerset, New Jersey, 08873

  • Orthopaedic Associates of Vero Beach

    Vero Beach, Florida, 32960

Other trials in United States

About this study

Official title: 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

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.

Read the 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.

Being tested
Total Knee Arthroplasty using LEGION™ Total Knee System
Keywords
LEGION™ Primary, TKA, Osteoarthritis of Knee
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Total Knee Arthroplasty using LEGION™ Total Knee SystemProcedure or surgery

    Primary Total Knee Arthroscopy using LEGION™ Total Knee System

Study groups in NCT04040985
Study groupRoleWhat they receive
LEGION™ PrimaryOtherLEGION™ Primary Total Knee Arthroplasty (TKA)
Receives: Procedure: Total Knee Arthroplasty using LEGION™ Total Knee System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Postoperatively through 120 months

Secondary outcomes (10)

  1. Knee Society Score (KSS) - Performance

    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.

    Measured: Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months

  2. Knee Society Score (KSS) - Function

    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.

    Measured: Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months

  3. Knee Osteoarthritis Outcome Score (KOOS) - Pain

    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.

    Measured: Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months

  4. Knee Osteoarthritis Outcome Score (KOOS) - Symptom

    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.

    Measured: Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months

  5. 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.

    Measured: Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months

  6. Knee Osteoarthritis Outcome Score (KOOS) - Sports and Recreational Activities

    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.

    Measured: Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months

  7. Knee Osteoarthritis Outcome Score (KOOS) - Quality of Life (QoL)

    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.

    Measured: Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months

  8. Radiographic Evaluation - Radiolucent Lines

    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

    Measured: Discharge, 3 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years

  9. Radiographic Evaluation - Observed Periosteal Hypertrophy, Implant Loosening, Osteolysis or Subsidence

    Performed weight bearing AP and lateral standard x-rays to identify knees that observed periosteal hypertrophy, implant loosening, osteolysis or subsidence (Yes/No).

    Measured: Discharge, 3 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years

  10. Radiographic Evaluation - Observed Patellar Problem

    Performed weight bearing AP and lateral standard x-rays to identify knees that observed patellar problems (Yes/No).

    Measured: Discharge, 3 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2019
  2. Study start9 Sep 2009
  3. Primary completion17 Dec 2020
  4. Study completion17 Dec 2020

Why it stopped: There is no regulatory or otherwise commitment to continue to follow up to the 10-year time point. The study data had met the primary objectives. After a business review, Smith+Nephew had decided to terminate the study prematurely.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04040985
Sponsor's protocol ID
10-K300-95301
Status last verified
Jan 2024
First submitted
18 Jul 2019
Last updated
10 Oct 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Total Knee Arthroplasty using LEGION™ Total Knee System in people with Osteo Arthritis Knee and Total Knee Replacement, run by Smith & Nephew, Inc. at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Implant Survivorship Percentage (time frame: Postoperatively through 120 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04040985.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2024.

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