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RECRUITING
NCT07818343
NA

Hinge vs CCK Implants

Sponsor: Medstar Health Research Institute

View on ClinicalTrials.gov

Summary

The primary purpose of this study is to compare reoperation rates for rotating hinge knee implants versus condylar constrained knee implants when used in revision total knee arthroplasty. The secondary purposes are to compare patient satisfaction, loosening rates and clinical outcomes for RHK implants compared to CCK implants in rTKA. Additionally, knee range of motion and stability will be assessed and compared at all follow-up time points. We hypothesize that RHK implants provide patients undergoing rTKA with similar reoperation rates to those of patients who receive a CCK implant. The investigators hypothesize that patients who receive an RHK implant will have similar loosening rates and clinical outcomes compared to patients who receive a CCK implant. Lastly, knee stability and patient satisfaction may improve with the use of a rotating hinge device.

Official title: A Randomized Controlled Trial Comparing Reoperation Rates and Clinical Outcomes of Rotating Hinge Versus Condylar Constrained Knee Implants in Revision Total Knee Arthroplasty

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

186

Start Date

2026-02-01

Completion Date

2037-01

Last Updated

2026-09-14

Healthy Volunteers

No

Interventions

DEVICE

Condylar Constrained knee system. ( NexGen Legacy Condylar Constrained Knee by Zimmer Biomet)

Patients in this group will receive a condylar constrained knee implant at the time of surgery and will have their outcomes with this implant assessed over 10 years.

DEVICE

Rotating Hinge Knee ( NexGen Rotating Hinge Knee by Zimmer Biomet)

Patients in this group will receive a rotating hinge knee implant and will be followed for the next 10 years to asses outcomes.

Locations (2)

Medstar Georgetown University Hospital

Washington D.C., District of Columbia, United States

Medstar Montgomery Medical Center

Olney, Maryland, United States