LEGION Hinge Safety and Efficacy Study

(LINKS Trial)

Recruiting at 9 trial locations

Overseen By Tammy Clark

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Smith & Nephew, Inc.

Disqualifiers: Malignant tumor, Morbid obesity, Uncontrolled diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 years

47 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Research Team

Rachael Winter

Principal Investigator

Smith & Nephew, Inc.

Eligibility Criteria

Inclusion Criteria

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 skeletally mature in Investigator's judgment i.e., subject is not actively growing or does not have immature bones for any reason

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the LEGION Hinge Knee System and are assessed for safety and efficacy

2 years

Regular follow-up visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

Treatment Details

Interventions

• LEGION Hinge Knee System

Participant Groups

Group I: LEGION Hinge Knee System Experimental Treatment 1 Intervention

This group will be receiving the LEGION Hinge device.

Who Is Running the Clinical Trial?

Smith & Nephew, Inc.

Lead Sponsor

Trials

176

Recruited

23,500+

Dr. Maria Berkman

Smith & Nephew, Inc.

Chief Medical Officer since 2023

MD from Harvard Medical School

Dr. Deepak Nath

Smith & Nephew, Inc.

Chief Executive Officer since 2022

PhD in Theoretical Mechanics, University of California, Berkeley