Revision ArthroplastyNCT07818343
Hinge vs CCK Implants
A study testing Condylar Constrained knee system. ( NexGen Legacy Condylar Constrained Knee by Zimmer Biomet) and Rotating Hinge Knee ( NexGen Rotating Hinge Knee by Zimmer Biomet) in people with Revision Arthroplasty and Knee, run by Medstar Health Research Institute at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Revision Arthroplasty, Knee
- What is being tested?
- Condylar Constrained knee system. ( NexGen Legacy Condylar Constrained Knee by Zimmer Biomet) and Rotating Hinge Knee ( NexGen Rotating Hinge Knee by Zimmer Biomet)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2026to Jan 2037
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing a revision total knee arthroplasty for any etiology
- Requires revision of both tibial and femoral components
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Medstar Montgomery Medical Center
Olney, Maryland, 20832
Miles Hollimon, B.S., (202) 444-8766, miles.hollimon@medstar.health
Katharine Harper, M.D.
- Recruiting
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Miles Hollimon, (202) 444-8766, miles.hollimon@medstar.net
Brett R Levine, M.D.
About this study
Official title: A Randomized Controlled Trial Comparing Reoperation Rates and Clinical Outcomes of Rotating Hinge Versus Condylar Constrained Knee Implants in Revision Total Knee Arthroplasty
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
- Being tested
- Condylar Constrained knee system. ( NexGen Legacy Condylar Constrained Knee by Zimmer Biomet), Rotating Hinge Knee ( NexGen Rotating Hinge Knee by Zimmer Biomet)
- Keywords
- CCK, Hinge, revision total knee arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 group | Role | What they receive |
|---|---|---|
| Condylar Constrained Knee | Active comparator | Patients in this arm will receive a condylar constrained implant. Receives: Device: Condylar Constrained knee system. ( NexGen Legacy Condylar Constrained Knee by Zimmer Biomet) |
| Rotating Hinge Knee | Active comparator | Patients in this arm will receive a rotating hinge knee implant. Receives: Device: Rotating Hinge Knee ( NexGen Rotating Hinge Knee by Zimmer Biomet) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reoperation Rate
The primary outcome is any reoperation on the ipsilateral knee.
Measured: 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
Patient reported outcomes including KOOS JR score. It is a score that ranges from 0-100, where 0 indicates total knee disability and 100 indicates perfect knee health.
Measured: 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
Aseptic loosening is verified through radiographic images.
Measured: 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
Range of motion at the knee joint will be assessed : flexion, extension, varus and valgus motion will be assessed.
Measured: 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)
Patient reported outcomes include knee society score (KSS). There is a knee score and functional score, both scored 0-100 with 0 indicating worse knee conditions and 100 indicating good knee conditions.
Measured: 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
A patient reported outcome survey assessing the patient's perspective on their overall health and quality of life. PROMIS assessments are scored on a T-score metric. High scores mean more of the concept being measured. 10 points on the T-score metric is one standard deviation (SD).
PROMIS scores have a mean of 50 and standard deviation (SD) of 10 in a referent population. The referent population is usually the US General Population.
A score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population. Interpretation Scores 0.5 - 1.0 SD worse than the mean = mild symptoms/impairment Scores 1.0 - 2.0 SD worse than the mean = moderate symptoms/impairment Scores 2.0 SD or more worse than the mean = severe symptoms/impairment
Measured: 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.
UCLA Activity Score
Patient reported outcome survey which is a 10-point rating scale used to measure a patient's physical activity level. Scale ranges from 1 (wholly inactive and dependent) to 10 (regular participation in impact sports).
Measured: 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.
EQ5D score
Patient reported survey that assesses mobility, pain, mental health, quality of life. A total score closer to 0 indicates poor health where a score closer to 1 indicates good health.
Measured: 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.
SANE score
A patient reported survey is a single-question rating scale from 0 to 100 where a patient grades their current knee function as a percentage of normal with 100 indicating that their knee is completely normal.
Measured: 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.
Radiographic assessment of fixation
An x-ray will be done to assess that the implant is in the correct position.
Measured: From time of surgery to end of study. Investigators will plan to assess for fixation at routine standard of care visits at the following time points: 6 weeks postoperatively, 6 months, 1 year, and then annually for 8 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start1 Feb 2026
- Primary completionJan 2037 (estimated)
- Study completionJan 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Revision ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07818343
- Sponsor's protocol ID
- STUDY00009790
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Reoperation Rates and Clinical Outcomes of Rotating Hinge Versus Condylar Constrained Knee Implants in Revision Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT07818343
- Acronym / sponsor ID
- STUDY00009790
- Conditions
- Revision Arthroplasty, Knee
- Keywords
- CCK, Hinge, revision total knee arthroplasty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- Jan 2037 (estimated)
- Study completion
- Jan 2037 (estimated)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Condylar Constrained Knee | Active comparator | Device: Condylar Constrained knee system. ( NexGen Legacy Condylar Constrained Knee by Zimmer Biomet)Patients in this arm will receive a condylar constrained implant. |
| Rotating Hinge Knee | Active comparator | Device: Rotating Hinge Knee ( NexGen Rotating Hinge Knee by Zimmer Biomet)Patients in this arm will receive a rotating hinge knee implant. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Undergoing a revision total knee arthroplasty for any etiology
- Requires revision of both tibial and femoral components
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Condylar Constrained Knee |
| 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. | Device | Rotating Hinge Knee |
Primary outcome
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
The primary outcome is any reoperation on the ipsilateral knee.
9 secondary outcomes
KOOS JR score
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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.
UCLA Activity Score
Time frame: 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.
EQ5D score
Time frame: 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.
SANE score
Time frame: 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.
Radiographic assessment of fixation
Time frame: From time of surgery to end of study. Investigators will plan to assess for fixation at routine standard of care visits at the following time points: 6 weeks postoperatively, 6 months, 1 year, and then annually for 8 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Condylar Constrained knee system. ( NexGen Legacy Condylar Constrained Knee by Zimmer Biomet) and Rotating Hinge Knee ( NexGen Rotating Hinge Knee by Zimmer Biomet) in people with Revision Arthroplasty and Knee, run by Medstar Health Research Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miles Hollimon, B.S. ((202) 444-8766, miles.hollimon@medstar.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.