LEGION Hinge Safety and Efficacy Study

NCT02445443 | Active Not Recruiting

• 1 other identifier: 13-4042-01
• Study Type: observational
• Target: 47
• Locations: 5 countries
• Sites: 7

Brief 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 primary Total Knee Arthroplasty (TKA).

Conditions

Knee Arthroplasty, Total

Outcome Measures

Primary Outcomes (2)

• 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.

  1 year

• Revision

  Revision, for any reason, will be assessed throughout the subject's participation in the study.

  Up to 5 years

Secondary Outcomes (7)

• Original Knee Society Functional Score© (KSFS)

  1 year

• Original Knee Society Functional Score© (KSFS)

  2 years

• 2011 Knee Society Score©

  1 year

• 2011 Knee Society Score©

  2 years

• EQ-5D-3L™

  1 year

Study Arms (1)

LEGION Hinge Knee System

This group will be receiving the LEGION Hinge device.

Device: LEGION Hinge Knee System

Interventions

LEGION Hinge Knee System DEVICE

All enrolled/treated subjects will receive the LEGION Hinge Knee System.

Also known as: LEGION HK

LEGION Hinge Knee System

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients requiring a revision total knee arthroplasty (TKA) using the LEGION Hinge Total Knee system.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (7)

University of Iowa Hospitals

Iowa City, Iowa, 52242, United States

Location

NYU Hospital for Joint Diseases

New York, New York, 10003, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Fremantle Hospital

Fremantle, Western Australia, 6160, Australia

Location

UZ Leuven campus Pellenberg

Pellenberg, 3212, Belgium

Location

Concordia Hip and Knee Institute

Winnipeg, Manitoba, R2K 2M9, Canada

Location

University Hospital Mutua de Terrassa

Terrassa, Barcelona, 08221, Spain

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2015
• First Posted: May 15, 2015
• Study Start: June 30, 2015
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: November 27, 2024

Record last verified: 2024-11

Locations

BE (1); US (3); CA (1); ES (1); AU (1)