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RECRUITING Not applicable ClinicalTrials.gov

Hinge vs CCK Implants

Sponsor: Medstar Health Research Institute • ClinicalTrials.gov ID: NCT07818343

Registry updated: 2026-09-14
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Description

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.

Interventions

  • Condylar Constrained knee system. ( NexGen Legacy Condylar Constrained Knee by Zimmer Biomet) (Device)
    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.
  • Rotating Hinge Knee ( NexGen Rotating Hinge Knee by Zimmer Biomet) (Device)
    Patients in this group will receive a rotating hinge knee implant and will be followed for the next 10 years to asses outcomes.

Eligibility criteria

Inclusion: * Undergoing a revision total knee arthroplasty for any etiology * Requires revision of both tibial and femoral components Exclusion: * Undergoing primary total knee arthroplasty * Candidate for only rotating hinge knee implant * Diagnosed with active infection * Does not meet age criteria of \>18 or \<80 * Pregnant or breastfeeding * Unable to consent * Non-independent dweller (prisoner)

Conditions

Revision Arthroplasty Knee

Locations

  • Medstar Georgetown University Hospital — Washington D.C., District of Columbia, United States
  • Medstar Montgomery Medical Center — Olney, Maryland, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record