Condylar vs Stabilized Bearing for Knee Replacement

Overseen By Omary Behery, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Rush University Medical Center

Disqualifiers: Hinged implant, Extensor mechanism disruption, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 21

Duration: Surgery and immediate post-operative period

170 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Constrained Condylar bearing, Posterior Stabilized bearing for knee replacement?

Research suggests that Constrained Condylar Knee (CCK) prostheses, used in challenging knee replacements, may offer better stability and patient-reported outcomes compared to Posterior Stabilized (PS) prostheses, despite a potentially reduced range of motion. ^{1 2 3 4 5}

Is the Condylar vs Stabilized Bearing for Knee Replacement generally safe for humans?

The studies show that both Condylar and Stabilized Bearing designs for knee replacement have been used successfully for many years, with no major safety concerns reported. They are designed to improve knee stability and function, and any differences in outcomes are related to function rather than safety. ^{1 3 5 6 7}

How does the Constrained Condylar bearing treatment differ from other knee replacement treatments?

The Constrained Condylar bearing treatment offers increased stability for the knee joint, especially in cases where more support is needed, compared to the Posterior Stabilized bearing. This may result in a slightly reduced range of motion but can lead to better functional outcomes as reported by patients. ^{1 3 4 6 8}

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for people aged 18-80 who need a second knee replacement surgery (revision TKA) and are at least 6 weeks out from their first surgery. They must have complete knee X-rays and be getting certain revision systems that fit with CCK or PS bearings. It's not for those over 80, less than 6 weeks post-first surgery, needing hinged implants, or with specific ligament or soft tissue issues.

Inclusion Criteria

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; Smith and Nephew Legion; DJO / Enovis Empowr; Stryker Triathlon; Link SymphoKnee; Depuy Attune

I had knee replacement surgery over 6 weeks ago and have all needed knee X-rays before and after surgery.

I am having a knee revision surgery for both femoral and tibial components, or just the femoral component with a compatible tibial part.

Exclusion Criteria

I am over 80, need a specific knee replacement, or my second knee surgery is within 6 weeks of the first.

I am having a knee replacement revision for specific parts only.

I need surgery for a knee problem and might need plastic surgery before that.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo revision total knee arthroplasty with either CCK or PS bearings

Surgery and immediate post-operative period

1 visit (in-person for surgery)

Follow-up

Participants are monitored for clinical outcomes and survivorship free of revision surgery

20 years

Multiple visits over 20 years

Treatment Details

Interventions

• Constrained Condylar bearing
• Posterior Stabilized bearing

Trial Overview The study compares Constrained Condylar Knee (CCK) bearings to Posterior Stabilized (PS) bearings in patients having a second knee replacement. The goal is to see which bearing leads to better patient satisfaction and surgical outcomes like how long the implant lasts without problems.

Participant Groups

Group I: Constrained condylar (CCK) Active Control 1 Intervention

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.

Group II: Posterior Stabilized (PS) bearing Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Comparison of mobile-bearing and fixed-bearing total knee arthroplasty: a prospective randomized study. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

International comparative evaluation of fixed-bearing non-posterior-stabilized and posterior-stabilized total knee replacements. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Clinical and Functional Outcomes: Primary Constrained Condylar Knee Arthroplasty Compared With Posterior Stabilized Knee Arthroplasty. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Mobile vs fixed-bearing total knee arthroplasty performed by a single surgeon: a 4- to 6.5-year randomized, prospective, controlled, double-blinded study. [2016]

5. United States pubmed.ncbi.nlm.nih.gov

International comparative evaluation of knee replacement with fixed or mobile-bearing posterior-stabilized prostheses. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Rationale for the posterior-stabilized rotating-platform knee. [2013]

7. China pubmed.ncbi.nlm.nih.gov

[Analysis of factors relating to clinical outcomes after total knee replacement]. [2016]

8. United States pubmed.ncbi.nlm.nih.gov

Posterior stabilized knee arthroplasty. Six years' experience. [2016]