Porous Baseplate Knee Replacement for Osteoarthritis

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new knee replacement option for individuals with painful knee osteoarthritis. It focuses on a special knee implant called the porous tibia baseplate with Journey Lock, which might improve stability and movement. Researchers aim to assess how this implant performs in individuals with good ligament health in the knee. Ideal participants are those with one-sided knee osteoarthritis who maintain good ligament function, indicating mostly stable knees. As an unphased trial, this study allows participants to contribute to innovative research that could enhance future knee replacement options.

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 prior data suggests that this device is safe for knee replacement surgery?

Research has shown that the Porous Tibia Baseplate with Journey Lock, used in knee replacement surgeries, has been studied for safety. Earlier versions of uncemented knee implants faced issues like poor attachment and early failure. However, improvements have been made.

One study examined the JOURNEY II XR total knee system, related to the Journey Lock system, and found it performed well for over 10 years, indicating long-term safety. Another study assessed a similar system, the Legion Porous System, and gathered data from patients to confirm its safety and effectiveness.

These findings suggest that while initial concerns existed, current designs like the Porous Tibia Baseplate with Journey Lock have shown improved safety in recent years. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional knee replacements that use solid metal baseplates, the porous tibia baseplate with Journey Lock stands out due to its innovative design. This baseplate features a porous structure that encourages bone growth into the implant, potentially leading to a more stable and long-lasting fit. Researchers are excited about this treatment because it may improve patient outcomes by reducing the risk of implant loosening over time, a common issue with current knee replacement options. This could mean longer-lasting relief for those suffering from osteoarthritis.

What evidence suggests that the Porous Tibia Baseplate with Journey Lock is effective for osteoarthritis?

Research has shown that the Porous Tibia Baseplate with Journey Lock, studied in this trial, may enhance knee stability and bond more effectively with bone due to its special porous design. In one study, patients who received this knee replacement improved their Knee Society score, which measures knee function, from an average of 51.7 to 76.7. Another study found that patients experienced significantly less pain after the procedure. Long-term follow-ups at 5 and 10 years have demonstrated that the results of using these cementless porous tibial components are as good as other methods, indicating durability and effectiveness. These findings suggest that this knee replacement design could be a promising option for reducing pain and improving knee function in people with osteoarthritis. ^{1 2 4 6 7}

Who Is on the Research Team?

Douglas Naudie, MD

Principal Investigator

London Health Sciences Centre

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40738233/

"Primary Total Knee Arthroplasty Using a Cementless ... The purpose of this study was to evaluate the clinical and radiographic results of primary TKA using a cementless, highly porous tibial ...

2. researchgate.net researchgate.net/publication/378797828_Gap_patterns_and_radiographic_follow-up_of_newer-generation_cementless_total_knee_arthroplasty_designs

(PDF) Gap patterns and radiographic follow-up of newer- ... At the most recent evaluation, the Knee Society score improved from an average preoperative value of 51.7 to 76.7, the pain score improved from ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38579049/

Efficacy of cementless porous tantalum tibial components ... Conclusion: The results of the 5-year and 10-year follow-ups indicate that the use of cementless porous tantalum tibial components is comparable ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03136887

JOURNEY II XR Safety and Effectiveness PMCF This study was designed to demonstrate the safety and performance of the JOURNEY II XR total knee system by evaluating implant survival rates at 10 years ...

5. withpower.com withpower.com/trial/phase-osteoarthritis-2-2022-f4c65

Porous Baseplate Knee Replacement 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, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11456906/

Uncemented Total Knee Arthroplasty is on the Rise. A Report ... Earlier reports on uncemented TKA designs raised concerns regarding fixation failure, early implant failure, and suboptimal clinical outcomes. Factors ...

7. clinicaltrial.be clinicaltrial.be/en/details/66675?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

Safety and Performance Study of the Legion Porous System... The purpose of this research is to collect data on patients that had the Legion Porous HA Tibial Baseplates and/or the Legion Porous HA Femoral ...