Recruiting

RHK vs. CCK

Sponsor:

Medstar Health Research Institute

Code:

NCT07818343

Conditions

Revision Arthroplasty

Knee

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

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

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

Study Details

Brief 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.

Conditions

Revision Arthroplasty

Knee

Study ID

NCT07818343

Start date

Feb 1, 2026

Status verified date

Jan, 2026

Completion date

Jan, 2037

Anticipated

Primary completion date

Jan, 2037

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

186 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Condylar Constrained Knee

Patients in this arm will receive a condylar constrained implant.

active comparator: Rotating Hinge Knee

Patients in this arm will receive a rotating hinge knee implant.

Interventions

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.

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.

Primary outcome measure

  • Reoperation Rate [ Time Frame: From time of surgery to end of study. Investigators will plan to assess for reoperation at routine standard of care visits at the following time points: 6 weeks postoperatively, 6 months, 1 year, and then annually for 8 years ]

Central Contacts and Locations

Central contacts

Miles Hollimon, B.S.

(202) 444-8766miles.hollimon@medstar.net

Locations

Medstar Georgetown University Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20007

Contacts

Miles Hollimon

(202) 444-8766miles.hollimon@medstar.net

Principal Investigator:

Brett R Levine, M.D.

Medstar Montgomery Medical Center

Recruiting

Olney, Maryland, United States, 20832

Contacts

Miles Hollimon, B.S.

(202) 444-8766miles.hollimon@medstar.health

Principal Investigator:

Katharine Harper, M.D.

More Information

Sponsor

Medstar Health Research Institute

Last update posted

Sep 14, 2026

Last verified

Jan, 2026

Keywords

  • CCK
  • Hinge
  • revision total knee arthroplasty

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-15. This information was provided to ClinicalTrials.gov by Medstar Health Research Institute on 2026-09-14.