Staged vs Simultaneous Knee Replacement for Osteoarthritis

Recruiting at 7 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

224 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Simultaneous Knee Arthroplasty (UKA) and Staged Knee Arthroplasty (UKA) for osteoarthritis?

Research suggests that simultaneous knee arthroplasty (UKA) can offer benefits like a single anesthesia session, shorter hospital stays, and lower medical costs compared to staged procedures. However, the risk of complications with simultaneous procedures is still debated, and more studies are needed to confirm its overall effectiveness. ^{1 2 3 4 5}

Is simultaneous or staged knee replacement safe for osteoarthritis?

Both simultaneous and staged unicompartmental knee arthroplasty (UKA) are generally safe, with low complication rates. However, simultaneous procedures may have a higher risk of increased blood loss and systemic complications compared to staged surgeries. ^{1 5 6 7 8}

How does simultaneous or staged knee arthroplasty differ from other treatments for osteoarthritis?

Simultaneous knee arthroplasty involves replacing both knees in one surgery, which can lead to a shorter hospital stay and lower medical costs compared to staged arthroplasty, where each knee is replaced in separate surgeries. This approach is unique because it offers the convenience of a single anesthesia administration, although the risk of complications is still debated. ^{1 2 3 5 7}

What is the purpose of this trial?

The purpose of this study is to assist surgeons and patients in answering the question "Should I have both knees replaced at the same time, or should I just do one and wait to do the second one?"

Research Team

Eric R. Bohm, MD

Principal Investigator

University of Manitoba

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Comparison of the therapeutic effect between the simultaneous and staged unicompartmental knee arthroplasty (UKA) for bilateral knee medial compartment arthritis. [2020]

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

Staged vs simultaneous bilateral unicompartmental knee arthroplasty for clinical outcomes: A protocol of systematic review and meta-analysis. [2023]

3. China pubmed.ncbi.nlm.nih.gov

[Comparison of early effectiveness and safety of simultaneous and staged bilateral unicompartmental knee arthroplasty for bilateral anteromedial compartment osteoarthritis]. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Outcomes of Bi-unicompartmental Versus Total Knee Arthroplasty for the Treatment of Medial and Lateral Knee Osteoarthritis: A Systematic Review and Meta-analysis of Comparative Studies. [2023]

5. China pubmed.ncbi.nlm.nih.gov

Clinical Outcomes and Risks of Single-stage Bilateral Unicompartmental Knee Arthroplasty via Oxford Phase III. [2018]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Comparison of early post-operative complications following unilateral or single-stage bilateral unicompartmental knee arthroplasty. [2022]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

Advantages of Simultaneous Cementless Bilateral Unicondylar Knee Arthroplasty Compared to Staged Surgery. [2023]

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

Fewer Adverse Events Following Outpatient Compared with Inpatient Unicompartmental Knee Arthroplasty. [2023]