Hinge vs CCK Implants

Conditions

• Knee
• Revision Arthroplasty

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

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.

Study Details

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.

Key Dates

First listed

Sep 14, 2026

Start date

Feb 1, 2026

Status verified

Jan 2026

Primary completion

Jan 31, 2037

Completion

Jan 31, 2037

Study Design

Enrollment

186 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.

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

• Miles Hollimon, B.S.
  (202) 444-8766
  [email protected]

Locations (2)

Find similar trials in Washington D.C., DC

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