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Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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)

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Condylar Constrained Knee 		Patients in this arm will receive a condylar constrained implant.
  • 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.
Active Comparator
Rotating Hinge Knee 		Patients in this arm will receive a rotating hinge knee implant.
  • 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.

Recruiting Locations

Medstar Georgetown University Hospital
Washington D.C., District of Columbia 20007
Contact:
Miles Hollimon
(202) 444-8766
miles.hollimon@medstar.net

Medstar Montgomery Medical Center
Olney, Maryland 20832
Contact:
Miles Hollimon, B.S.
(202) 444-8766
miles.hollimon@medstar.health

More Details

Status
Recruiting
Sponsor
Medstar Health Research Institute

Study Contact

Miles Hollimon, B.S.
(202) 444-8766
miles.hollimon@medstar.net

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.