Triathlon Knee Replacement for Knee Arthritis

(APT Trial)

Not currently recruiting at 5 trial locations

Overseen By Seth Greenky

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stryker Orthopaedics

Must not be taking: Steroids

Disqualifiers: Infection, Skeletal immaturity, Neuromuscular disorder, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess the effectiveness of the Triathlon All-Polyethylene Tibia Knee device in individuals with knee arthritis. Researchers seek to understand the device's impact on knee function and overall mobility. It is intended for those who have already undergone this specific knee replacement and do not have infections or significant knee instability. Participants must commit to regular follow-ups and check-ups after surgery. As an unphased trial, this study provides participants the opportunity to contribute to valuable research that could enhance future knee replacement outcomes.

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 the Triathlon All-Polyethylene Tibia Knee device is safe?

Research shows that patients generally receive the Triathlon All-Polyethylene Tibia Knee device well. Studies have demonstrated positive results with this knee replacement. Notably, one study found that it moves less after implantation compared to metal-backed parts. This reduces the chance of the knee becoming loose over time, promising long-term stability.

The available research has not reported any specific serious side effects linked to this device. While all medical procedures carry some risks, current evidence suggests that the Triathlon All-Polyethylene Tibia Knee is a safe choice for those needing knee replacement. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Triathlon All-Polyethylene Tibia Knee is unique because it uses a single polyethylene material for the tibial component in knee replacements, which differs from the typical metal and polyethylene combination. This design aims to reduce wear and tear, potentially increasing the longevity of the knee replacement. Researchers are excited about this treatment as it could offer a more durable solution for those suffering from knee arthritis, potentially reducing the need for revision surgeries and improving long-term outcomes for patients.

What evidence suggests that the Triathlon All-Polyethylene Tibia Knee device is effective for knee arthritis?

Studies have shown that the Triathlon All-Polyethylene Tibia Knee device, which all participants in this trial will receive, may benefit people with knee arthritis. Research suggests that using all-plastic parts in knee replacements might outperform those with metal backing. A review of several studies found that these plastic parts can lead to better results in knee replacement surgery. Specifically, patients with a higher body mass index (BMI) who received this device had good outcomes at least two years after surgery. This suggests the device might improve knee function and reduce pain. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have had a primary total knee replacement using the Triathlon All-Polyethylene Tibia and compatible components, without plans for revision. Participants must be able to follow up with clinical evaluations. Those with infections, compromised bone stock, mental or neuromuscular disorders, excessive steroid use, or are prisoners cannot join.

Inclusion Criteria

I have a Triathlon knee implant with no plans for changes.

Patient has signed an IRB-approved, study specific Informed Patient Consent Form.

I am willing and able to follow up with all required post-surgery check-ups and scans.

Exclusion Criteria

Patient is a prisoner.

My knee is very unstable because of damaged ligaments.

I was on high-dose steroids or had a weakened immune system during my surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Retrospective Data Collection

Data obtained retrospectively from medical records from preoperative to shortly after surgery

Not specified

Follow-up

Participants are evaluated at their 5-year and 10-year post-surgery anniversary dates

10 years

Evaluations at 5-year and 10-year postoperative

What Are the Treatments Tested in This Trial?

Interventions

• Triathlon All-Polyethylene Tibia Knee

Trial Overview The study aims to assess the functional outcomes of patients who received the Triathlon All-Polyethylene Tibia Knee Device during knee replacement surgery. It will involve scheduled clinical and radiographic evaluations post-surgery.

How Is the Trial Designed?

Group I: Triathlon All-Polyethylene Tibia Knee Experimental Treatment 1 Intervention

All subjects enrolled will have received the Triathlon All-Polyethylene Tibia Knee device.

Triathlon All-Polyethylene Tibia Knee is already approved in United States, European Union for the following indications:

Approved in United States as Triathlon All-Polyethylene Tibia for:

• Painful, disabling joint disease of the knee resulting from non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis)
• Rheumatoid arthritis or post-traumatic arthritis
• Post-traumatic loss of knee joint configuration and function
• Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability
• Revision of previous unsuccessful knee replacement or other procedure
• Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture management techniques

Approved in European Union as Triathlon All-Polyethylene Tibia for:

• Painful, disabling joint disease of the knee resulting from non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis)
• Rheumatoid arthritis or post-traumatic arthritis
• Post-traumatic loss of knee joint configuration and function
• Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability
• Revision of previous unsuccessful knee replacement or other procedure
• Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture management techniques

Who Is Running the Clinical Trial?

Stryker Orthopaedics

Lead Sponsor

Trials

79

Recruited

20,500+

Kevin A. Lobo

Stryker Orthopaedics

Chief Executive Officer since 2012

Bachelor's degree in Commerce from McGill University, MBA from University of Toronto

Dr. Jorge Enrique Diaz

Stryker Orthopaedics

Chief Medical Officer since 2023

MD from University of Michigan Medical School

Published Research Related to This Trial

In a study of 266 patients who received a Triathlon knee replacement, significant improvements in pain, function, and quality of life were observed within the first 3 months post-surgery, with smaller gains continuing up to 12 months.

The survivorship rate of the Triathlon knee replacement was high at 96.6% after 5 years, and 86% of patients reported satisfaction with their outcomes, indicating good mid-term effectiveness of the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

5 Year Outcomes and Survivorship of the Triathlon Total Knee Replacement: a Cohort Study. Wylde, V., Dixon, S., Miller, LL., et al.[2019]

In a study involving 60 patients, both the posterior stabilised and cruciate retaining versions of the Triathlon™ total knee prosthesis showed similar early stability in terms of tibial component migration over a two-year follow-up period.

Despite differences in specific types of movement (translation) between the two prosthesis types, there were no significant differences in clinical outcomes or functional performance, indicating both designs are effective options for knee arthroplasty.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Similar early migration when comparing CR and PS in Triathlon™ TKA: A prospective randomised RSA trial. Molt, M., Toksvig-Larsen, S.[2014]

In a study involving 59 patients, the all-polyethylene tibial component showed significantly less migration than the metal-backed component after 2 years, indicating a potentially lower risk of late aseptic loosening.

Both all-polyethylene and metal-backed groups demonstrated similar improvements in clinical outcomes, suggesting that while the all-polyethylene design may have advantages in migration, it does not compromise overall functional recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Migration of all-polyethylene compared with metal-backed tibial components in cemented total knee arthroplasty. Van Hamersveld, KT., Marang-Van De Mheen, PJ., Nelissen, RGHH., et al.[2019]

The Stryker Triathlon Total Knee System shows excellent survivorship rates of 98.7% overall and 99.2% for aseptic causes, based on a systematic review of 20 studies with a mean follow-up of 3.8 years.

Clinical outcomes are also promising, with average Knee Society Scores (KSS) indicating high levels of pain relief (92.2) and functional improvement (82.7), suggesting effective performance of the cementless implant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes and survivorship of cementless triathlon total knee arthroplasties: a systematic review. Carlson, BJ., Gerry, AS., Hassebrock, JD., et al.[2022]

The Triathlon total knee replacement (TKR) showed excellent outcomes, with a 95.4% survivorship rate at 10 years post-surgery, indicating its long-term reliability for patients.

Patients experienced significant improvements in pain and function within the first three months after surgery, with satisfaction rates ranging from 79% to 94% over the follow-up period, demonstrating the effectiveness of the Triathlon prosthesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ten-Year Results of the Triathlon Knee Replacement: A Cohort Study. Wylde, V., Penfold, C., Rose, A., et al.[2021]

Patients with the Triathlon(®) total knee replacement reported significantly better outcomes in pain relief, function, quality of life, and satisfaction compared to those with the Kinemax Plus prosthesis, based on a study of 453 knees (233 Kinemax Plus and 220 Triathlon) with follow-up at 3 months and 1 year post-surgery.

The Triathlon(®) prosthesis appears to facilitate a quicker return to function and greater pain reduction within the first three months after surgery, indicating its potential advantages over the previous design.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of patient reported outcomes after Triathlon(®) and Kinemax Plus prostheses. Dixon, S., Blom, AW., Whitehouse, MR., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04636190?term=AREA%5BBasicSearch%5D(triathlon%20knee)&rank=9

Triathlon All-Polyethylene Tibia Outcomes Study (APT) The purpose of this study is to evaluate the clinical functional results of the Triathlon All-Polyethylene Tibia Knee Device. Detailed Description. This study ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10651551/

All-polyethylene versus metal-backed tibial components in ... This meta-analysis suggests that all-polyethylene tibial components in total knee arthroplasty may offer advantages over metal-backed components.

3. arthroplastyjournal.org arthroplastyjournal.org/article/S0883-5403(23)00328-5/fulltext

Minimum 2-Year Outcomes of All-Polyethylene Tibial ... This study aims to analyze the minimum 2-year outcomes in patients who have a body mass index (BMI) > 35 undergoing cemented TKA using an all-polyethylene ...

4. stryker.com stryker.com/content/dam/stryker/no-index/training-and-education/jr45/june/resources/Triathlon%20Design%20Rationale.pdf

Triathlon design rationale The Triathlon Total Knee System offers surgeons a variety of options depending on disease, deformity and demand. Option. Varus/valgus constraint. Internal/.

5. trials.arthritis.org trials.arthritis.org/trials/NCT04636190

Triathlon All-Polyethylene Tibia Outcomes Study The purpose of this study is to evaluate the clinical functional results of the Triathlon All-Polyethylene Tibia Knee Device. Recruitment Criteria. Accepts ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6066763/

Migration of all-polyethylene compared with metal-backed ... Interpretation — The Triathlon all-polyethylene tibial component showed less migration, suggesting a lower risk of late loosening as compared with its metal- ...

7. stryker.com stryker.com/content/dam/stryker/no-index/training-and-education/jr45/june/resources/Triathlon%20Knee%20Replacement%20Presentation.pdf

Triathlon® ... Triathlon CS Tibial. Insert demonstrated excellent clinical outcomes that were comparable to the results obtained with the Triathlon PS. Tibial Insert.32. • In ...

8. isrctn.com isrctn.com/ISRCTN10744502

All-polyethylene tibia PS components compared to metal ... The primary outcome measure will be prosthetic migration after two years of the Triathlon PS Knee System with all-polyethylene tibial components and the ...