Aseptic Loosening of Prosthetic JointPhase 4NCT06782295
The Use of CCK vs PS in Revision TKAs
A Phase 4 study testing Constrained Condylar bearing and posterior stabilized bearing in people with Aseptic Loosening of Prosthetic Joint and Instability of Prosthetic Joint, run by Rush University Medical Center at 1 site in United States.
Trial summary
This study aims to compare the clinical impact of Constrained Condylar versus Posterior Stabilized Knee (PS) bearings on patient satisfaction and surgical outcomes including mid-term survivorship among patients undergoing revision total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aseptic Loosening of Prosthetic Joint, Instability of Prosthetic Joint, Reimplantation for Periprosthetic Joint Infection
- What is being tested?
- Constrained Condylar bearing and posterior stabilized bearing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2025to 1 Jul 2038
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between 18-80 years of age
- Patients who are undergoing both femoral and tibial component revisions, or isolated femoral component revisions with a retained tibial component that is compatible with PS or CCK bearings
- Patients who are at least 6-weeks out from primary TKA surgery, with complete pre-operative and post-operative knee radiographs obtained at standard of care perioperative visits (AP/lateral and patellar views)
- Patients undergoing rTKA for indications including aseptic component loosening, flexion or extension coronal or sagittal instability, component malalignment, arthrofibrosis, patellar maltracking, reimplantation following single or two-stage exchange revision for prosthetic joint infection or bearing surface wear when femoral or tibial component revision is indicated.
- The use of revision total knee arthroplasty systems which have PS and CCK bearing options including different degree options of coronal and rotational constraint (to be individually randomized per constrained option):
- Zimmer Biomet Persona, NexGen, or Vanguard
Show all 11Show fewer
- Smith and Nephew Legion
- DJO / Enovis Empowr
- Stryker Triathlon
- Link SymphoKnee
- Depuy Attune sion Criteria:
Who cannot join
- Patients undergoing rTKA with a hinged implant, or pre-operatively determined to require CCK bearing rTKA, > 80 years of age, or those requiring rTKA less than 6-weeks from the primary TKA,
- Patients undergoing rTKA for bearing exchange only rTKA, isolated tibial component rTKA
- Patients with pre-operative diagnosis of extensor mechanism disruption or collateral ligament incompetence or with a compromised soft tissue envelope requiring pre-pre-operative plastic surgery evaluation and planned soft tissue coverage.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: A Prospective Randomized Controlled Trial Comparing Constrained Condylar vs Posterior Stabilized Articulations in Revision Total Knee Arthroplasty
This study aims to compare the clinical impact of Constrained Condylar versus Posterior Stabilized Knee (PS) bearings on patient satisfaction and surgical outcomes including mid-term survivorship among patients undergoing revision total knee arthroplasty.
Read the detailed description
The primary purpose of this study is to determine whether a difference exists in clinical patient reported outcomes between CCK or PS bearings following rTKA. A secondary goal of the study is to compare both bearings in survivorship free of revision surgery as well as other surgical complications including instability, in early to mid-term follow-up.
- Conditions
- Aseptic Loosening of Prosthetic Joint, Instability of Prosthetic Joint, Reimplantation for Periprosthetic Joint Infection, Femoral Revision Indicated, Tibial Component Revision
- Being tested
- Constrained Condylar bearing, posterior stabilized bearing
- Keywords
- revision total knee replacement, cck, ps, coronal instability, sagittal instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constrained Condylar bearingDevice
Also called CCK
Patients in this intervention will receive a CCK bearing component
posterior stabilized bearingDevice
Patients in this intervention will receive a PS bearing component
| Study group | Role | What they receive |
|---|---|---|
| Constrained condylar (CCK) | Active comparator | Once patient meets inclusion criteria, they'll be randomized prior to surgery to a specific CCK implant design. All surgeries will be done at the approved hospital or ASC and if the allocated component isn't used, the patient will still be followed post operatively and remain in the study. Receives: Device: Constrained Condylar bearing |
| Posterior Stabilized (PS) bearing | Active comparator | Once patient meets inclusion criteria, they'll be randomized prior to surgery to a specific PS implant design. All surgeries will be done at the approved hospital or ASC and if the allocated component isn't used, the patient will still be followed post operatively and remain in the study. Receives: Device: posterior stabilized bearing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical patient reported outcomes
patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time. The clinical patient reported outcomes of a revision total knee replacement to detect a 6-point difference in knee society score (KSS)
Measured: 6 weeks post op
Clinical patient reported outcomes
Patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time. The clinical patient reported outcomes of a revision total knee replacement to detect a 6-point difference in knee society score (KSS)
Measured: 1 year post op
Clinical patient reported outcomes
Patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time. The clinical patient reported outcomes of a revision total knee replacement to detect a 6-point difference in knee society score (KSS)
Measured: 2 year post op
Clinical patient reported outcomes
Patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time. The clinical patient reported outcomes of a revision total knee replacement to detect a 6-point difference in knee society score (KSS)
Measured: 5 year post op
Clinical patient reported outcomes
Patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time. The clinical patient reported outcomes of a revision total knee replacement to detect a 6-point difference in knee society score (KSS)
Measured: 10 year post op
Clinical patient reported outcomes
Patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time. The clinical patient reported outcomes of a revision total knee replacement to detect a 6-point difference in knee society score (KSS)
Measured: 20 year post op
Secondary outcomes (5)
Clinical reported outcomes (Koos Jr)
patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time
Measured: 6 weeks to 20 years post op
Range of motion over time
Patients will have their knee range of motion (ROM) checked prior to revision surgery and at multiple timepoints after surgery
Measured: pre op to 20 years pots op
Clinical reported outcomes ( VR-12)
patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time
Measured: 6 weeks, 1 year, 2 years, 5 years, 10 years, 15 years, 20 years post op
Clinical reported outcomes ( Forgotten Joint Score)
patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time
Measured: 6 weeks to 20 years post op
Clinical reported outcomes (EQ-5D-3L)
patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time
Measured: 6 weeks, 1 year, 2 years, 5 years, 10 years, 15 years, 20 years post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start1 Jul 2025
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aseptic Loosening of Prosthetic JointStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial with two groups: constrained condylar (CCK) vs posterior stabilized (PS) articulating bearings. These are standard bearings used in revision knees, comparing two types.
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Behery, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06782295
- Sponsor's protocol ID
- 25010208
- Status last verified
- Nov 2025
- First submitted
- 3 Jan 2025
- Last updated
- 14 Nov 2025
- Results posted
- No
- Data monitoring committee
- 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 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial Comparing Constrained Condylar vs Posterior Stabilized Articulations in Revision Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06782295
- Acronym / sponsor ID
- 25010208
- Conditions
- Aseptic Loosening of Prosthetic Joint, Instability of Prosthetic Joint, Reimplantation for Periprosthetic Joint Infection, Femoral Revision Indicated, Tibial Component Revision
- Keywords
- revision total knee replacement, cck, ps, coronal instability, sagittal instability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2038 (estimated)
- First posted
- 17 Jan 2025 (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.
This study aims to compare the clinical impact of Constrained Condylar versus Posterior Stabilized Knee (PS) bearings on patient satisfaction and surgical outcomes including mid-term survivorship among patients undergoing revision total knee arthroplasty.
Detailed description
The primary purpose of this study is to determine whether a difference exists in clinical patient reported outcomes between CCK or PS bearings following rTKA. A secondary goal of the study is to compare both bearings in survivorship free of revision surgery as well as other surgical complications including instability, in early to mid-term follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial with two groups: constrained condylar (CCK) vs posterior stabilized (PS) articulating bearings. These are standard bearings used in revision knees, comparing two types.
| Arm | Type | Receives |
|---|---|---|
| Constrained condylar (CCK) | Active comparator | Device: Constrained Condylar bearingOnce patient meets inclusion criteria, they'll be randomized prior to surgery to a specific CCK implant design. All surgeries will be done at the approved hospital or ASC and if the allocated component isn't used, the patient will still be followed post operatively and remain in the study. |
| Posterior Stabilized (PS) bearing | Active comparator | Device: posterior stabilized bearingOnce patient meets inclusion criteria, they'll be randomized prior to surgery to a specific PS implant design. All surgeries will be done at the approved hospital or ASC and if the allocated component isn't used, the patient will still be followed post operatively and remain in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients between 18-80 years of age
- Patients who are undergoing both femoral and tibial component revisions, or isolated femoral component revisions with a retained tibial component that is compatible with PS or CCK bearings
- Patients who are at least 6-weeks out from primary TKA surgery, with complete pre-operative and post-operative knee radiographs obtained at standard of care perioperative visits (AP/lateral and patellar views)
- Patients undergoing rTKA for indications including aseptic component loosening, flexion or extension coronal or sagittal instability, component malalignment, arthrofibrosis, patellar maltracking, reimplantation following single or two-stage exchange revision for prosthetic joint infection or bearing surface wear when femoral or tibial component revision is indicated.
- The use of revision total knee arthroplasty systems which have PS and CCK bearing options including different degree options of coronal and rotational constraint (to be individually randomized per constrained option):
Key exclusion criteria (4 listed)
- Patients undergoing rTKA with a hinged implant, or pre-operatively determined to require CCK bearing rTKA, > 80 years of age, or those requiring rTKA less than 6-weeks from the primary TKA,
- Patients undergoing rTKA for bearing exchange only rTKA, isolated tibial component rTKA
- Patients with pre-operative diagnosis of extensor mechanism disruption or collateral ligament incompetence or with a compromised soft tissue envelope requiring pre-pre-operative plastic surgery evaluation and planned soft tissue coverage.
- -
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 |
|---|---|---|
| Constrained Condylar bearingAlso: CCKPatients in this intervention will receive a CCK bearing component | Device | Constrained condylar (CCK) |
| posterior stabilized bearingPatients in this intervention will receive a PS bearing component | Device | Posterior Stabilized (PS) bearing |
Primary outcome
Clinical patient reported outcomes
Time frame: 6 weeks post op
patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time. The clinical patient reported outcomes of a revision total knee replacement to detect a 6-point difference in knee society score (KSS)
Clinical patient reported outcomes
Time frame: 1 year post op
Patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time. The clinical patient reported outcomes of a revision total knee replacement to detect a 6-point difference in knee society score (KSS)
Clinical patient reported outcomes
Time frame: 2 year post op
Patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time. The clinical patient reported outcomes of a revision total knee replacement to detect a 6-point difference in knee society score (KSS)
Clinical patient reported outcomes
Time frame: 5 year post op
Patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time. The clinical patient reported outcomes of a revision total knee replacement to detect a 6-point difference in knee society score (KSS)
Clinical patient reported outcomes
Time frame: 10 year post op
Patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time. The clinical patient reported outcomes of a revision total knee replacement to detect a 6-point difference in knee society score (KSS)
Clinical patient reported outcomes
Time frame: 20 year post op
Patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time. The clinical patient reported outcomes of a revision total knee replacement to detect a 6-point difference in knee society score (KSS)
5 secondary outcomes
Clinical reported outcomes (Koos Jr)
Time frame: 6 weeks to 20 years post op
Range of motion over time
Time frame: pre op to 20 years pots op
Clinical reported outcomes ( VR-12)
Time frame: 6 weeks, 1 year, 2 years, 5 years, 10 years, 15 years, 20 years post op
Clinical reported outcomes ( Forgotten Joint Score)
Time frame: 6 weeks to 20 years post op
Clinical reported outcomes (EQ-5D-3L)
Time frame: 6 weeks, 1 year, 2 years, 5 years, 10 years, 15 years, 20 years post op
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 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Aseptic Loosening of Prosthetic Joint
RecruitingObservational study
Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Revision Hip Prosthesis System
Revision Hip Arthroplasty, Aseptic Loosening of Prosthetic Joint
Not yet recruitingObservational study
Artificial Intelligence to Detect Early Total Knee Replacement Implant Failure
Aseptic Loosening of Prosthetic Joint
Recruiting
DIGITAL-KNEE Study: Adequately Diagnosing Total Knee Arthroplasty Loosening by Evaluating the AtMoves Knee System in a Routine Clinical Setting
Aseptic Loosening, Aseptic Loosening of Prosthetic Joint
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Constrained Condylar bearing and posterior stabilized bearing in people with Aseptic Loosening of Prosthetic Joint and Instability of Prosthetic Joint, run by Rush University Medical Center at 1 site 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 11 inclusion and 4 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 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Omary Behery, MD (630-339-2230, omar.behery@rushortho.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical patient reported outcomes (time frame: 6 weeks post op). The study lists 6 primary outcomes in all. 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 Nov 2025.