Staged vs Simultaneous Knee Replacement for Osteoarthritis

Not currently recruiting at 8 trial locations

Overseen By Sarah Tran

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Orthopaedic Innovation Centre

Disqualifiers: Significant knee contractures, others

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

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best approach for knee replacement in people with osteoarthritis: replacing both knees simultaneously or one at a time. The researchers compare two types of surgery: partial knee replacement (only part of the knee) and total knee replacement (the whole knee). They aim to determine which method and timing provide the best outcomes for patients. This trial may suit individuals needing both knees replaced who can commit to completing questionnaires during the study. As an unphased trial, it offers patients the chance to contribute to important research that could enhance knee replacement outcomes for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these knee replacement methods are safe?

Research has shown that both simultaneous and staged knee replacements are generally safe for treating knee osteoarthritis. Studies have found that patients undergoing simultaneous knee replacements do not face a higher risk of complications during surgery. These procedures might even save money and reduce the number of surgeries needed. In one study, the artificial knee joint lasted well in about 93% of cases.

Staged knee replacements are also safe and effective. They typically involve shorter surgery times and hospital stays, with no increase in complications compared to other methods. Both types of knee replacements are considered reliable options for people with osteoarthritis, making them good choices for those considering this type of clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial comparing staged versus simultaneous knee replacement for osteoarthritis because it could reveal important differences in recovery and outcomes between these two surgical approaches. Unlike traditional knee replacement options, which typically involve replacing one knee at a time (staged), simultaneous knee replacement allows for both knees to be treated in a single procedure. This approach could lead to faster overall recovery times, less time spent in rehabilitation, and reduced overall healthcare costs. By comparing these two methods, researchers hope to determine the optimal approach for patient convenience and long-term joint function.

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

This trial will compare simultaneous and staged knee replacement surgeries for treating osteoarthritis. In the simultaneous knee replacement arm, both knees are replaced at the same time. Research has shown this approach can reduce the number of surgeries needed without increasing surgical risk, saving money and helping avoid post-surgery complications. In the staged knee replacement arm, each knee is replaced one at a time. One study found that the artificial knee joint lasts well, with a 92.96% success rate. Both methods provide good results for patients, but replacing both knees at once might be more efficient for some individuals. ^{1 3 4 6 7}

Who Is on the Research Team?

Eric R. Bohm, MD

Principal Investigator

University of Manitoba

Are You a Good Fit for This Trial?

This trial is for individuals considering bilateral knee arthroplasty, who are able to sign a consent form and willing to complete study questionnaires. It's not suitable for those unable to fill out the questionnaires or who need simultaneous surgery due to severe knee contractures.

Inclusion Criteria

Patients must sign the consent form

I am considering surgery for both of my knees.

I am willing to fill out study questionnaires for the study duration.

Exclusion Criteria

Patients who are unable to complete the questionnaires

I need both knees replaced at the same time due to severe knee issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo either simultaneous or staged bilateral knee arthroplasty

Up to 1 week

1 visit (in-person)

Post-operative Recovery

Participants recover from surgery and are monitored for complications and hospital stay

Up to 1 week

Follow-up

Participants are monitored for safety, effectiveness, and quality of life outcomes

24 months

Multiple visits (in-person and virtual) at 6, 12, 18, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Simultaneous Knee Arthroplasty (UKA)
• Staged Knee Arthroplasty (UKA)

Trial Overview The study aims to determine whether it's better for patients with osteoarthritis to have both knees replaced at once (simultaneous) or one at a time (staged). Participants will be assigned one of these two surgical approaches.

How Is the Trial Designed?

Group I: Unicompartmental Knee Arthroplasty (UKA) Active Control 2 Interventions

Patient will have half-knee replacement (partial) - Simultaneous vs Staged

Group II: Total Knee Arthroplasty (TKA) Active Control 2 Interventions

Patient will have complete replacement - Simultaneous vs Staged

Who Is Running the Clinical Trial?

Orthopaedic Innovation Centre

Lead Sponsor

Trials

7

Recruited

670+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11481757/

Simultaneous bilateral and staged total knee arthroplasty ... In the UKA side knee joint, 5 cases of revision surgery occurred in the SB-TKA/UKA group, and the survival rate of prosthesis was 92.96%. Staged ...

2. nature.com nature.com/articles/s41598-024-81995-7

Comparison of clinical outcomes of bilateral and unilateral ... Simultaneous bilateral UKA reduces the number of procedures without increasing the risk of surgical complications, but results in a markedly enhanced ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2059775421001267

Simultaneous bilateral unicompartmental knee arthroplasty ... One-stage simultaneous bilateral UKA can be performed with preventing the postoperative complication, and result in cost savings for patients.

4. journals.lww.com journals.lww.com/atmr/fulltext/2024/07000/a_systematic_review_and_meta_analysis_comparing.3.aspx

A Systematic Review and Meta-analysis Comparing... UKA offers superior clinical and functional outcomes but with higher revision rates compared to TKA. These findings support UKA for physically active ...

5. frontiersin.org frontiersin.org/journals/surgery/articles/10.3389/fsurg.2024.1405025/full

Comparative long-term outcomes of unicompartmental and ... UKA shows a trend towards better outcomes in KSFS and ROM, alongside a more favorable survival rate in TKA at the five-year and beyond follow-up periods.

6. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-024-05173-1

Simultaneous bilateral and staged total knee arthroplasty ... In the UKA side knee joint, 5 cases of revision surgery occurred in the SB-TKA/UKA group, and the survival rate of prosthesis was 92.96%. Staged ...

7. sicot-j.org sicot-j.org/articles/sicotj/full_html/2025/01/sicotj250025/sicotj250025.html

Safety and early outcomes of simultaneous bilateral TKA in ... This study suggests that SBTKA in patients with a BMI > 40 is safe, with no increased complications, similar surgical time, and blood loss.