Knee Arthroplasty, TotalLINKSNCT02445443
LEGION Hinge Safety and Efficacy Study
An observational study of Knee Arthroplasty, Total, run by Smith & Nephew, Inc. at 7 sites in 5 countries.
Trial summary
The purpose of the current investigation is to assess the safety and efficacy of a new hinged revision knee device. This device is designed to provide efficient, reproducible reconstructions with optimal limb and implant alignment, durable implant fixation, and functional outcomes that increasingly approach those of… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Knee Arthroplasty, Total
- What is being tested?
- LEGION Hinge Knee System
- Type of treatment
- Medical device
- How many people
- 47 participants
- Where
- 7 sitesin 5 countries
- Study dates
- 30 Jun 2015to 1 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients requiring a revision total knee arthroplasty (TKA) using the LEGION Hinge Total Knee system.
Who may be able to join
- Subject has gross knee instability resulting from loss of collateral ligament function, gross bone loss, comminuted fractures of the proximal tibia or distal femur, rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, degenerative arthritis, failed osteotomies, unicompartmental replacement or total knee replacement, or absent or incompetent posterior cruciate ligament and one or both of the collateral ligaments
- Subject has a failed primary or revision knee replacement
- Subject is 18-80 years of age
- Subject is skeletally mature in Investigator's judgment i.e., subject is not actively growing or does not have immature bones for any reason
- Subject has met an acceptable preoperative medical clearance and is free of or treated for cardiac, pulmonary, hematological, infection or other conditions that would pose excessive operative risk
- Subject is willing to sign and date an IRB/EC-approved consent form
Show all 9Show fewer
- Subject plans to be available through the five (5) year postoperative follow-up
- If of child bearing potential, Subject reports she is not pregnant nor plans to become pregnant during the study
- Subject agrees to follow the study protocol
Who cannot join
- Subject is receiving the study device as a primary knee replacement
- Subject has presence of malignant tumor, metastatic, or neoplastic disease
- Subject is not expected to return to normal ambulatory function (i.e., morbid obesity or other limiting co-morbidities)
- Subject is pregnant or plans to become pregnant during the course of the study
- Subject has conditions that may interfere with the revision arthroplasty survival or outcome (i.e., Paget's or Charcot-Marie-Tooth disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease)
- Subject has known (Subject reported) metal hypersensitivity
Show all 11Show fewer
- Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in this study
- Subject has BMI>45
- Subject is participating in any other pharmaceutical, biologic, or medical device clinical investigation or has been treated with an investigational product in the past 30 days
- Subject is facing current or impending incarceration
- Subject is not a good candidate for the study based on Investigator opinion
Trial locations and contacts
7 sites in 5 countries.
7 sites in 5 countries
United States3 sites
University of Iowa Hospitals
Iowa City, Iowa, 52242
NYU Hospital for Joint Diseases
New York, New York, 10003
Oregon Health and Science University
Portland, Oregon, 97239
About this study
Official title: A Prospective, Multi-center Clinical Study Evaluating the LEGION™ Hinge Knee System
The purpose of the current investigation is to assess the safety and efficacy of a new hinged revision knee device. This device is designed to provide efficient, reproducible reconstructions with optimal limb and implant alignment, durable implant fixation, and functional outcomes that increasingly approach those of primary Total Knee Arthroplasty (TKA).
Read the detailed description
The objective of this study is to demonstrate statistically significant improvements in the original Knee Society Clinical Score (KSCS) from baseline to 1 and 2 years in subjects using the LEGION™ Hinge Knee System. The focus of the 1 and 2 year analyses will be on safety and efficacy. The 5 year analysis will focus on survivorship and safety.
- Conditions
- Knee Arthroplasty, Total
- Being tested
- LEGION Hinge Knee System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEGION Hinge Knee SystemDevice
Also called LEGION HK
All enrolled/treated subjects will receive the LEGION Hinge Knee System.
| Study group | Role | What they receive |
|---|---|---|
| LEGION Hinge Knee System | This group will be receiving the LEGION Hinge device. Receives: Device: LEGION Hinge Knee System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Original Knee Society Clinical Score© (KSCS)
The original Knee Society Score© (KSS) is subdivided into two parts. One part is the Knee Society Clinical Score (KSCS) and the other part is the Knee Society Functional Score (KSFS). The KSCS will be administered at the pre-operative visit and all follow-up visits. The purpose of administering this assessment is to determine the statistical clinical improvement over time which may be compared to literature at 1 and 2 years.
Measured: 1 year
Revision
Revision, for any reason, will be assessed throughout the subject's participation in the study.
Measured: Up to 5 years
Secondary outcomes (7)
Original Knee Society Functional Score© (KSFS)
The original Knee Society Score© (KSS) is subdivided into two parts. One part is the Knee Society Clinical Score (KSCS) and the other part is the Knee Society Functional Score (KSFS). The purpose of administering this assessment is to determine the statistical clinical improvement over time which may be compared to literature at 1 and 2 years.
Measured: 1 year
Original Knee Society Functional Score© (KSFS)
The original Knee Society Score© (KSS) is subdivided into two parts. One part is the Knee Society Clinical Score (KSCS) and the other part is the Knee Society Functional Score (KSFS). The purpose of administering this assessment is to determine the statistical clinical improvement over time which may be compared to literature at 1 and 2 years.
Measured: 2 years
2011 Knee Society Score©
2011 Knee Society Knee Score and all of it's components
Measured: 1 year
2011 Knee Society Score©
2011 Knee Society Knee Score and all of it's components
Measured: 2 years
EQ-5D-3L™
The EuroQol EQ-5D-3L™ is a descriptive system measuring health-related Quality Of Life (QOL) and consists of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which takes one of three responses. The responses record three levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D-3L™ dimension. The EQ-5D-3L™ is completed by the Subject on the day of their visit.
Measured: 1 year
EQ-5D-3L™
The EuroQol EQ-5D-3L™ is a descriptive system measuring health-related Quality Of Life (QOL) and consists of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which takes one of three responses. The responses record three levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D-3L™ dimension. The EQ-5D-3L™ is completed by the Subject on the day of their visit.
Measured: 2 years
Original Knee Society Clinical Score© (KSCS)
The original Knee Society Score© (KSS) is subdivided into two parts. One part is the Knee Society Clinical Score (KSCS) and the other part is the Knee Society Functional Score (KSFS). The KSCS will be administered at the pre-operative visit and all follow-up visits. The purpose of administering this assessment is to determine the statistical clinical improvement over time which may be compared to literature at 1 and 2 years.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2015 (estimated)
- Study start30 Jun 2015
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Arthroplasty, TotalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02445443
- Sponsor's protocol ID
- 13-4042-01
- Acronym
- LINKS
- Status last verified
- Nov 2024
- First submitted
- 30 Apr 2015
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center Clinical Study Evaluating the LEGION™ Hinge Knee System
- ClinicalTrials.gov ID
- NCT02445443
- Acronym / sponsor ID
- LINKS / 13-4042-01
- Conditions
- Knee Arthroplasty, Total
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2015 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 15 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the current investigation is to assess the safety and efficacy of a new hinged revision knee device. This device is designed to provide efficient, reproducible reconstructions with optimal limb and implant alignment, durable implant fixation, and functional outcomes that increasingly approach those of primary Total Knee Arthroplasty (TKA).
Detailed description
The objective of this study is to demonstrate statistically significant improvements in the original Knee Society Clinical Score (KSCS) from baseline to 1 and 2 years in subjects using the LEGION™ Hinge Knee System. The focus of the 1 and 2 year analyses will be on safety and efficacy. The 5 year analysis will focus on survivorship and safety.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LEGION Hinge Knee System | – | Device: LEGION Hinge Knee SystemThis group will be receiving the LEGION Hinge device. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients requiring a revision total knee arthroplasty (TKA) using the LEGION Hinge Total Knee system.
Key inclusion criteria (9 listed)
- Subject has gross knee instability resulting from loss of collateral ligament function, gross bone loss, comminuted fractures of the proximal tibia or distal femur, rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, degenerative arthritis, failed osteotomies, unicompartmental replacement or total knee replacement, or absent or incompetent posterior cruciate ligament and one or both of the collateral ligaments
- Subject has a failed primary or revision knee replacement
- Subject is 18-80 years of age
- Subject is skeletally mature in Investigator's judgment i.e., subject is not actively growing or does not have immature bones for any reason
- Subject has met an acceptable preoperative medical clearance and is free of or treated for cardiac, pulmonary, hematological, infection or other conditions that would pose excessive operative risk
Key exclusion criteria (11 listed)
- Subject is receiving the study device as a primary knee replacement
- Subject has presence of malignant tumor, metastatic, or neoplastic disease
- Subject is not expected to return to normal ambulatory function (i.e., morbid obesity or other limiting co-morbidities)
- Subject is pregnant or plans to become pregnant during the course of the study
- Subject has conditions that may interfere with the revision arthroplasty survival or outcome (i.e., Paget's or Charcot-Marie-Tooth disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LEGION Hinge Knee SystemAlso: LEGION HKAll enrolled/treated subjects will receive the LEGION Hinge Knee System. | Device | LEGION Hinge Knee System |
Primary outcome
Original Knee Society Clinical Score© (KSCS)
Time frame: 1 year
The original Knee Society Score© (KSS) is subdivided into two parts. One part is the Knee Society Clinical Score (KSCS) and the other part is the Knee Society Functional Score (KSFS). The KSCS will be administered at the pre-operative visit and all follow-up visits. The purpose of administering this assessment is to determine the statistical clinical improvement over time which may be compared to literature at 1 and 2 years.
Revision
Time frame: Up to 5 years
Revision, for any reason, will be assessed throughout the subject's participation in the study.
7 secondary outcomes
Original Knee Society Functional Score© (KSFS)
Time frame: 1 year
Original Knee Society Functional Score© (KSFS)
Time frame: 2 years
2011 Knee Society Score©
Time frame: 1 year
2011 Knee Society Score©
Time frame: 2 years
EQ-5D-3L™
Time frame: 1 year
EQ-5D-3L™
Time frame: 2 years
Original Knee Society Clinical Score© (KSCS)
Time frame: 2 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
Related trials for Knee Arthroplasty, Total
Active, not recruiting
Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty
Pain
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
RecruitingPhase 2/3
Evaluation of PLG0206 in Prevention of Recurrent Infection in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Following Knee Arthroplasty
Prosthetic-joint Infection
Not yet recruitingObservational study
Agreement Between Patient-Reported Pain, Observer-Rated Pain Behavior, and Analgesic Request After Total Knee Arthroplasty
Postoperative Pain After Total Knee Arthroplasty
Enrolling by invitationObservational study
Smartphone Video-Based AI Gait Analysis Reports to Support Remote Follow-up After Total Knee Arthroplasty
Total Knee Arthroplasty
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Arthroplasty, Total, run by Smith & Nephew, Inc. at 7 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. 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: under way, not looking for participants, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Australia, Belgium, Canada, Spain. 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?
This study is still under way. Results are not available in the source record yet.
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?
Original Knee Society Clinical Score© (KSCS) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Nov 2024.