Porous Baseplate Knee Replacement for Osteoarthritis

Recruiting at 1 trial location

Overseen By Anna Kim

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Canadian Radiostereometric Analysis Network

Disqualifiers: Infection, Major surgery, Life expectancy, others

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

Compensation: Varies

Number of Visits: 9

31 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. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the Porous Tibia Baseplate with Journey Lock treatment for knee replacement in osteoarthritis?

The research on similar treatments, like the uncemented hydroxyapatite-coated Duracon tibial baseplate, shows excellent outcomes with no reoperations needed for issues like loosening or fractures, suggesting that modern tibial baseplate designs can be effective in knee replacements for osteoarthritis. ^{1 2 3 4 5}

Is the Porous Baseplate Knee Replacement generally safe for humans?

The safety of the Porous Baseplate Knee Replacement has been evaluated in several studies. While fractures of the tibial baseplate are rare, they have been reported, particularly in cases of component misalignment or wear. Regular follow-up is recommended to monitor for any potential issues. ^{2 3 4 6 7}

How is the Porous Tibia Baseplate with Journey Lock treatment different from other knee replacement treatments for osteoarthritis?

The Porous Tibia Baseplate with Journey Lock is unique because it uses a highly porous design that may enhance stability and integration with the bone, potentially reducing the risk of subsidence (sinking of the implant). This design is part of a trend towards cementless fixation, which aims to improve long-term outcomes by allowing natural bone growth into the implant. ^{3 4 5 6 8}

What is the purpose of this trial?

This trial involves patients undergoing knee replacement surgery using new parts designed to fit and function like natural knee components. The study will monitor how well these parts stay in place and how patients recover over time. It aims to ensure the new parts are effective and safe for people needing knee replacements.

Research Team

Douglas Naudie, MD

Principal Investigator

London Health Sciences Centre

Eligibility Criteria

This trial is for adults over 21 with knee osteoarthritis needing a total knee replacement, who can follow the study's procedures and provide consent. It's not for those with inflammatory joint diseases, prior infections, severe obesity (BMI >40), conditions that make surgery risky, or certain knee deformities.

Inclusion Criteria

Patients willing and able to comply with follow-up requirements and self-evaluations

My knee's ligaments are strong enough to keep the back one.

I need a knee replacement due to severe arthritis pain.

Exclusion Criteria

I am expected to have knee replacement surgery on the other knee within a year.

My doctor expects me to live more than 2 years.

I need knee replacement surgery on both knees due to deformity.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Assessment

Patient health and functional outcomes are recorded preoperatively

1 week

1 visit (in-person)

Surgery and Immediate Post-operative

Patients undergo cruciate-retaining total knee arthroplasty and immediate post-operative assessments

1 week

1 visit (in-person)

Post-operative Monitoring

Post-operative model-based RSA to identify migration of components and record health outcomes

2 years

Multiple visits at 6 weeks, 6 months, 1 year, and 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Follow-up visits at 1 year and 2 years

Treatment Details

Interventions

• Porous Tibia Baseplate with Journey Lock

Trial Overview The trial tests a new type of tibial baseplate used in cruciate-retaining total knee arthroplasty. Participants will receive this porous baseplate along with compatible components to see how well it works and integrates into the body.

Participant Groups

Group I: POROUS TIBIA BASEPLATE W/ JRNY LOCK Experimental Treatment 1 Intervention

Fixed-bearing POROUS TIBIA BASEPLATE W/ JRNY LOCK and a Legion cruciate-retaining High-Flex or Deep-dish XLPE tibial insert.

Who Is Running the Clinical Trial?

Canadian Radiostereometric Analysis Network

Lead Sponsor

Trials

9

Recruited

420+

References

1. Mexico pubmed.ncbi.nlm.nih.gov

[Cemented polyethylene insert in a well fixed Total knee replacement. Case report]. [2019]

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

Retrospective evaluation of the Duracon periapatite-coated tibial tray: midterm results and factors affecting success. [2013]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Tibial baseplate fracture associated with polyethylene wear and osteolysis after total knee arthroplasty. [2021]

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

Early Tibial Component Fractures in a Cementless, 3D-Printed, Titanium Implant. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Comparison of the primary stability of different tibial baseplate concepts to retain both cruciate ligaments during total knee arthroplasty. [2018]

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

Axial and Sagittal Rotation of Cementless Tibial Baseplates Occurs in Bone Under Joint Loading. [2023]

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

Catastrophic tibial baseplate failure of a modern cementless total knee arthroplasty implant. [2020]

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

Contemporary cruciate-retaining total knee arthroplasty with a pegged tibial baseplate. Results at a minimum of ten years. [2016]