170 Participants Needed

Condylar vs Stabilized Bearing for Knee Replacement

AD
OB
Overseen ByOmary Behery, MD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Rush University Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of knee implant bearings to determine which one improves patient satisfaction and surgical outcomes after knee replacement surgery. Patients will receive either a Constrained Condylar bearing or a Posterior Stabilized bearing. The goal is to identify which implant performs better in the medium term and enhances patient satisfaction with knee surgeries. The study seeks participants who had a knee replacement at least six weeks ago and now require another surgery to address issues like loose components or other knee problems. As a Phase 4 trial, the treatment has already received FDA approval and proven effective, aiming to understand its benefits for more patients.

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 is the safety track record for these treatments?

Research has shown that both Constrained Condylar and Posterior Stabilized bearings are generally safe choices for knee replacement surgeries.

Constrained Condylar bearings effectively manage challenging knee replacement cases, leading to positive outcomes and fewer complications compared to some other knee implants. However, their long-term performance remains uncertain, as the durability over many years is not fully established.

Posterior Stabilized bearings, in contrast, have demonstrated durability and effectiveness. One study tracked patients for at least 15 years and found these implants performed well over time. Another study confirmed their safety and effectiveness shortly after surgery.

Both options are generally well-tolerated by patients. While some uncertainty exists about the long-term outcomes for Constrained Condylar bearings, research suggests both options are generally safe for knee replacement.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the Condylar and Posterior Stabilized bearings for knee replacement because they offer potentially improved stability and motion compared to current options. Unlike traditional knee implants that might not fully address complex knee issues, the Constrained Condylar bearing provides enhanced stability, which can be critical for patients with significant ligament deficiencies. Meanwhile, the Posterior Stabilized bearing is designed to mimic the knee's natural movement more closely, potentially offering a more natural feel and function. These innovations could lead to better outcomes and increased satisfaction for patients undergoing knee replacement surgery.

What evidence suggests that this trial's treatments could be effective for knee replacement?

This trial will compare the Constrained Condylar (CCK) knee implant with the Posterior Stabilized (PS) implant. Studies have shown that the CCK knee implant can lead to better results and higher patient satisfaction compared to other knee implants. Specifically, one study found that patients with CCK implants reported improved knee function and greater satisfaction. Long-term follow-up has demonstrated that these implants can function well and last over 11 years in some cases. Research on PS implants indicates they also perform well, often lasting at least 15 years. Although some studies have raised concerns about their durability, overall results have been positive, showing reliable knee function and patient satisfaction. Both CCK and PS implants have proven effective in knee replacement surgeries.35678

Are You a Good Fit for This Trial?

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.
See 1 more

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: Constrained condylar (CCK)Active Control1 Intervention
Group II: Posterior Stabilized (PS) bearingActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials
448
Recruited
247,000+

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/38353709/
Clinical outcome and survival rate of condylar constrained ...The purpose of this study is to report the long-term clinical and radiographic outcome, implant survival rate, and surgical safety of revision total knee ...
Long-term results (after a mean 11.3 years, and up to 22 ...Long-term results (after a mean 11.3 years, and up to 22 years, of follow-up) of the Legacy Constrained Condylar Knee (LCCK™) in primary total knee arthroplasty.
Condylar constrained knee prosthesis and rotating hinge ...Results: The CCK group had significantly better clinical outcomes and satisfaction rates compared to patients with RHK (KSS-knee 70.5 versus ...
Complex primary total knee arthroplasty with constrained ...Rai et al. [10] reported favorable functional outcomes and implant survivorship in a cohort of 38 patients undergoing CCK-TKA for post-traumatic ...
Condylar constrained knee prosthesis and rotating hinge ...Results: The CCK group had significantly better clinical outcomes and satisfaction rates compared to patients with RHK (KSS-knee 70.5 versus 60.7 (p < 0.003) ...
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40420245/
Complex primary total knee arthroplasty with constrained ...This study aimed to analyze the demographic characteristics and operative details of patients undergoing complex primary TKA with constrained ...
Long-term outcomes of primary constrained condylar knee ...Although constrained condylar knee (CCK) inserts are widely used for total knee arthroplasty (TKA), their long-term outcomes remain unclear.
Clinical Outcomes of Revision Total Knee Arthroplasty ...Conclusion: Constrained condylar knee (CCK) prostheses can also be considered a good option to manage difficult cases of total knee arthroplasty revision, with ...
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