Hinge vs CCK Implants
A Randomized Controlled Trial Comparing Reoperation Rates and Clinical Outcomes of Rotating Hinge Versus Condylar Constrained Knee Implants in Revision Total Knee Arthroplasty
1 other identifier
interventional
186
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2026
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2026
CompletedStudy Start
First participant enrolled
February 1, 2026
CompletedFirst Posted
Study publicly available on registry
September 14, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2037
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2037
September 14, 2026
January 1, 2026
10.9 years
January 9, 2026
September 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reoperation Rate
The primary outcome is any reoperation on the ipsilateral knee.
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
Secondary Outcomes (9)
KOOS JR score
From time of surgery to end of study. Investigators will obtain patient reported outcomes at routine standard of care visits at the following time points: preop visit and then 6 weeks postoperatively, 6 months, 1 year, and then annually for 8 years.
Aseptic Loosening
Investigators will plan to assess for Aseptic loosening at routine standard of care visits at the following time points: 6 weeks postoperatively, 6 months, 1 year, and then yearly thereafter for 8 years through radiographs
Range of motion
Investigators will plan to assess range of motion at routine standard of care clinic visits at the following time points: 6 weeks postoperatively, 6 months, 1 year, and then yearly after for 8 years
Knee society score (KSS)
From time of surgery to end of study. Investigators will plan to assess for PROMs at routine standard of care visits at the following time points: pre-op visit, 6 weeks postoperatively, 6 months, 1 year, and then annually for 8 years
PROMIS score
From time of surgery to end of study. Investigators will obtain patient reported outcomes at routine standard of care visits at the following time points: preop visit and then 6 weeks postoperatively, 6 months, 1 year, and then annually for 8 years.
- +4 more secondary outcomes
Other Outcomes (1)
Any other surgical complications
Investigators will plan to assess for complications at routine standard of care visits at the following time points: 2 weeks postoperatively, 6 weeks postoperatively, 6 months, 1 year, and then yearly after for 8 years
Study Arms (2)
Condylar Constrained Knee
ACTIVE COMPARATORPatients in this arm will receive a condylar constrained implant.
Rotating Hinge Knee
ACTIVE COMPARATORPatients in this arm will receive a rotating hinge knee implant.
Interventions
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.
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
You may qualify if:
- Undergoing a revision total knee arthroplasty for any etiology
- Requires revision of both tibial and femoral components
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Medstar Montgomery Medical Center
Olney, Maryland, 20832, United States
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2026
First Posted
September 14, 2026
Study Start
February 1, 2026
Primary Completion (Estimated)
January 1, 2037
Study Completion (Estimated)
January 1, 2037
Last Updated
September 14, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share